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Psycho-Oncology Psycho-Oncology 18: 795–810 (2009) Published online 17 December 2008 in Wiley InterScience (www.interscience.wiley.com). DOI: 10.1002/pon.1443

Review

Psychosocial interventions and quality of life in gynaecological cancer patients: a systematic review Jolyn Hersch, Ilona Juraskova, Melanie Price and Barbara Mullan Medical Psychology Research Unit, School of Psychology, University of Sydney, New South Wales, Australia

* Correspondence to: Medical Psychology Research Unit, School of Psychology, Brennan MacCallum bld. (A18), University of Sydney, NSW 2006, Australia. . E-mail: [email protected]. edu.au

Received: 6 March 2008 Revised: 11 July 2008 Accepted: 31 July 2008

Abstract Objective: Women with gynaecological cancer are at risk of poor quality of life outcomes. Although various psychosocial interventions have been developed to address these concerns, such interventions have not yet been systematically evaluated in this population. The current review provides an up-to-date and comprehensive summary of the evidence regarding the effectiveness of psychosocial interventions in women with gynaecological cancers. Methods: Relevant studies were identified via Medline, CINAHL, and PsycINFO databases (1980 to June 2008), reference lists of articles and reviews, grey literature databases, and consultations with physicians and other experts in the field. Only controlled trials comparing a psychosocial intervention with a control group in a gynaecological cancer population, with at least one quality of life variable as a main outcome, were included in the review. Two authors independently assessed trial quality and extracted data. Results: Twenty-two studies involving 1926 participants were included. There was substantial variability in study quality and results. Evidence was mixed regarding intervention effects on social and sexual functioning, distress, depression, anxiety, attitude to medical care, selfesteem and body image. Interventions generally did not improve physical or vocational outcomes. Conclusions: There was limited evidence in support of healing touch, whereas informationbased interventions seemed largely unable to provide meaningful benefits. Cognitivebehavioural interventions had some positive effects. Counselling appeared to be the most promising intervention strategy for addressing quality of life concerns for women with gynaecological cancers. Copyright r 2008 John Wiley & Sons, Ltd. Keywords: systematic review; psychosocial interventions; quality of life; gynaecological cancer; gynaecological oncology

Gynaecological cancers account for approximately 942 000 new cases per year worldwide or 19% of all female cancers [1]. Both incidence rates and prognosis vary widely across countries. In Australia, incidence per 100 000 females is 15.9 for cancer of the uterus, 10.1 for ovarian cancer, 7.0 for cervical cancer, 1.9 for cancer of the vulva, and 0.6 for vaginal cancer [2]. Five-year survival in Australia is estimated to be 81% for cancer of the uterus, 75% for cervical cancer, and 42% for ovarian cancer [3]. In recent years, there has been increasing recognition of the importance of quality of life (QoL) when considering outcomes of disease [4]. QoL reflects a patient’s subjective evaluation of all dimensions of their health experience, including physical health, psychological state, level of independence, social relationships, personal beliefs, and their relationship to salient features of the environment [5]. For people with a life-

Copyright r 2008 John Wiley & Sons, Ltd.

threatening illness, multiple aspects of QoL may be impaired by the challenges associated with both disease and treatment [4]. It is well documented that many cancer patients suffer long-term psychological distress [6,7]. Standard medical treatments, including surgery, chemotherapy, and radiation therapy, can also be detrimental to QoL [4]. For example, in addition to the physical impact of chemotherapy on QoL, the associated alopecia may adversely affect body image [8], impacting on psychological and social aspects of QoL. Moreover, a diagnosis of gynaecological cancer may entail additional consequences beyond those common to all cancer patients. Gynaecological malignancies may be particularly distressing because the body parts involved are emotionally charged, being associated with femininity, sexuality, and childbearing [9]. Impairment in sexual functioning is common among gynaecological

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cancer patients due to anatomical or physiological changes following treatment [10]. Sexual dysfunction may also be exacerbated or caused by psychological factors such as the erosion of self-esteem, which may have negative consequences for intimate relationships [4]. Therefore, women with gynaecological cancers are in need of interventions to address specific aspects of QoL. Various psychosocial interventions have been developed to address a range of factors that challenge QoL in cancer patients. A psychosocial intervention may be defined as any treatment intended to address psychological, social, and/or spiritual needs [11], rather than the medical disease itself. These interventions commonly incorporate a number of different components but can generally be classified as primarily based on education, social support development, cognitive-behavioural techniques, or counselling. Many interventions include an educational component to satisfy patients’ needs for comprehensive information about their disease, treatment options, and potentially helpful coping strategies. A lack of accurate information can lead to erroneous beliefs or fears that may constitute barriers to adequate management of symptoms or treatment side effects [12], and hence have a detrimental impact on QoL outcomes. Myths that cancer can be ‘caught’ through sexual activity, that resuming intercourse will trigger cancer recurrence, or that a sexual partner can be exposed to radiation from a previously irradiated vagina are still relatively prevalent [13]. Thus, the provision of factual information can counter specific misconceptions and help patients to develop accurate expectations [12]. Some interventions involve contact between cancer patients during which common experiences can be shared. For example, a person who has previously suffered from cancer can explain to a new patient the strategies she found useful in coping with the illness [14]. Interventions are sometimes conducted in a group format to allow patients to compare their experiences with those of others in similar situations, thereby promoting the normalisation of feelings [10]. Cognitive-behavioural therapies may facilitate successful processing by helping women to actively deal with cognitive and affective aspects of their cancer experience [15]. Coping may be enhanced through developing problem-solving skills and learning behavioural techniques that can be incorporated into daily life [10]. Supportive interventions may minimise distress by enhancing feelings of control [16]. There is some evidence supporting the positive effects of psychosocial interventions on QoL outcomes in the general oncology population [17,18]. In spite of this apparently favourable evidence, however, reviewers have thus far been unable to draw firm conclusions and have stressed the need Copyright r 2008 John Wiley & Sons, Ltd.

J. Hersch et al.

for further research [19,20]. This is partly because results from different trials are simply inconsistent with each other [20]. For example, in a recent largescale review of psychological therapies for cancer patients [19], 24 trials found no significant impact on general affect whereas 9 trials had significant positive results. Moreover, methodological shortcomings create another major problem for the evaluation of intervention studies. For example, out of 155 randomised controlled trials (RCTs) analysed in the aforementioned review, most trials either failed to fulfil an adequate number of methodological quality indicators or provided insufficient information for assessment. The reviewers also raised the issues of small samples increasing the likelihood of type II errors and short follow-up periods prohibiting evaluation of longterm effectiveness [19]. In addition, it is important to recognise that the issues and vulnerabilities of particular importance in women with gynaecological cancers may differ from those affecting cancer patients in general. To our knowledge, this is the first systematic review to date that limits its scope to only psychosocial intervention studies focusing mainly or entirely on the gynaecological cancer population. The purpose of the present review is to provide a comprehensive summary of the evidence regarding the effectiveness of psychosocial interventions in women with gynaecological cancers. The primary aim is to evaluate whether or not these interventions result in better QoL outcomes compared with control conditions.

Materials and methods Literature search strategy Electronic literature searches were performed using Medline, CINAHL, and PsycINFO databases (1980–June 2008). Separate lists of keywords were used to identify studies including the types of participants, interventions, and outcomes relevant to the review, and the results were then combined. The search for appropriate participants was conducted using the subject heading female genital neoplasms. This term is valid in Medline and CINAHL, and explodes to include ovarian neoplasms, uterine neoplasms (including cervix neoplasms and endometrial neoplasms), vaginal neoplasms, and vulvar neoplasms. In order to ensure adequate coverage of relevant studies, such as in PsycINFO, the keywords gyn(a)ecologic(al) cancer and gyn(a)ecologic(al) oncology were also used. Relevant outcomes were located using the following subject headings and keywords: quality of life, self-concept, body image, well being, adjustment, psychological adaptation, depression, distress, sexual dysfunction. To identify appropriate intervention Psycho-Oncology 18: 795–810 (2009) DOI: 10.1002/pon

Psychosocial interventions in gynaeoncology

search terms, an initial scoping exercise was conducted exploring the utility of 34 different terms across the three databases. The following subject headings and keywords were thereby determined to be sufficient to achieve coverage of all relevant intervention studies: psychotherapy, counsel(l)ing, relaxation, patient education, client education, intervention, oncologic nursing, alternative therapies. Reference lists of identified papers and of reviews in related areas were manually searched for additional studies. Contact was made with two senior practising gynae-oncologists to assist with the identification of new or unpublished studies that might be pertinent to the review. In addition, the CRISP online database of current funded research was searched for relevant projects, and several authors were contacted regarding the availability of data from unpublished intervention studies.

Study selection criteria Types of studies

Only studies that described and evaluated a psychosocial intervention were eligible for inclusion in this review. All comparative designs with concurrent controls, whether or not allocation was random, were considered. There was no restriction according to the duration of follow-up. Types of participants

The participants were women diagnosed with gynaecological cancers, including cancers of the cervix, uterus, ovaries, vulva, and vagina. All studies with samples consisting only of gynaecological cancer patients, whether homogenous or heterogeneous for the site of malignancy, were eligible for inclusion in the review. In addition, studies including only women with either gynaecological cancer or breast cancer were also eligible, provided that gynaecological cancer patients made up at least one-third of the sample. This type of mixed sample was considered appropriate due to the key commonalities between breast and gynaecological cancers, specifically the fact that they both affect sites associated with femininity, sexuality, and childbearing. Studies including patients with any other type of cancer were not eligible. There were no restrictions according to age or number of participants. Types of interventions

Studies eligible for inclusion in the review evaluated psychosocial interventions to improve QoL. These included interventions based around elements such as psychotherapy, counselling, relaxation, and other complementary therapies and the provision of education and support. There were no Copyright r 2008 John Wiley & Sons, Ltd.

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restrictions according to the frequency, intensity, or duration of interventions. Types of outcome measures

The primary outcome of interest was QoL. In the current review, this term was conceptualised as encompassing disease symptoms, treatment side effects, mood and distress, self-concept, body image, relationship and sexual functioning, overall adjustment to life with cancer, and general sense of well-being. All studies that reported at least one of these aspects of QoL as a main outcome were eligible for inclusion in the review. There were no restrictions according to the method of outcome assessment.

Methods of the review The abstracts of the identified records were screened for relevance. Articles were rejected if it was determined from the abstract that the study failed to meet the selection criteria. When an abstract could not be rejected with certainty, the full text of the article was obtained for further evaluation. Any ambiguities regarding the application of the selection criteria were resolved through consultation among the authors. A review template was developed specifying the key information about each study (see Tables 1 and 2). This information was extracted independently by two reviewers (J. H. and I. J.), and the results were compared. Discrepancies were resolved by consensus. Two reviewers independently rated the level of evidence provided by each included study. This was performed according to the Australian National Health and Medical Research Council (NHMRC) evidence rating system as follows: ‘Level I: evidence obtained from a systematic review of all relevant RCTs. Level II: evidence obtained from at least one properly designed randomised controlled trial. Level III-1: evidence obtained from well-designed pseudo-RCTs. Level III-2: evidence obtained from comparative studies with concurrent controls and allocation not randomised, case–control studies, or interrupted time series with a control group. Level III-3: evidence obtained from comparative studies with historical control, two or more single-arm studies, or interrupted time series without a parallel control group’. [21]. The two reviewers compared results and resolved any discrepancies by consensus.

Results Literature search results Electronic database searching yielded 386 bibliographic records (after removing duplicates). One additional study was identified through the CRISP Psycho-Oncology 18: 795–810 (2009) DOI: 10.1002/pon

III-2

II

III-1

Capone et al. [9] (USA)

Cain et al. [32] (USA)

Houts et al. [14] (USA)

Reference Level of & country evidence

Eligibility criteria n 5 97. Approximately 68% cervical. Stages I–IV, approximately 53% stage I. Age 20–80 years.

Psychologist. Individual counselling (4 or more sessions). Program modelled on crisis intervention with focus on shaping reality-based expectations, facilitating attainment, encouraging adaptive behavioural change, reintegration of holistic concept of self, processing of information. Material tailored to needs of each patient.

Intervention & provider Counselling (n 5 56), no counselling (n 5 41): these already treated patients were enrolled when they returned for scheduled medical examination 3 months posttreatment

Comparison groups Initial assessment: questionnaires1 interview by psychologist before medical treatment (intervention group only). Intervention throughout hospital stay; assessments repeated at 3, 6, 12 month posttreatment medical examinations.

Study schedule

Outcome/secondary measures

Cohort study: inhospital crisis counselling vs. control

Diagnosed no more than 6 weeks ago, hospitalised & about to begin initial treatment, informed of cancer diagnosis. Able to read & speak English.

CR 87%. Post-test & follow-up RR not stated.

Self-Rating Symptom Scale (depression, fear -anxiety, performance difficulty, somatisation, general neurotic feelings), Profile Of Mood States (tension-anxiety, depression-dejection, anger-hostility, fatigueinertia, confusionbewilderment), Tennessee Self-Concept Scale; scales have established reliability & validity. Data also collected on employment status, frequency of intercourse. Initial assessment by Hamilton Depression Individual Social worker. 8 weekly n 5 80. 47% Newly diagnosed, no CR 85%. RCT: thematic medical social worker Scale, Hamilton Anxiety counselling sessions of thematic endometrial, Post-test previous cancer individual (n 5 21), group using structured counselling, either RR 90%. 1- 25% ovarian. history, expected counselling vs. Scale, Psychosocial individually or in groups of counselling Stages I–IV, 2 wk survival of at least 1 thematic group Adjustment to Illness Scale interview format. (n 5 28), 4–6. Themes based on approximately follow-up year. No severe counselling vs. Intervention. Repeat (health, vocational, standard 43% stage I, 37% authors’ past experience. psychiatric problems RR 75%. standard interview assessment domestic, sexual counselling stage II. Mean age Sessions included now or previously. counselling 1-2 weeks after end relationship, extended (n 5 31): usual information, discussion of 59 years. Age 18–75, living family, leisure, psychologic of counselling. interactions feelings & problems, within 60 miles of the Follow-up interview distress). All scales were problem solving. Additional between patient assessment 6 months interviewer-rated. All have hospital. & physicians/ input by oncologic nurse established reliability & after end of nurses/social and/or other staff. validity. counselling. worker Profile Of Mood States Initial assessment Counselling by Social worker. TelephCR 98%. Six n 5 40. Sites & Pseudo-RCT: Newly diagnosed, during 1st clinic visit. (established reliability & former cancer stages of cancer one counselling (three & twelve just beginning counselling by validity)1post-intervention patients1usual First session of wk follow- not given. Mean sessions) by experienced former cancer treatment. only: questionnaire about intervention shortly care (n 5 14 female social worker, who up total RR age 50 years. patients vs. control thereafter, just prior degree to which after had cancer. Four coping 80%. respondent used four to hospitalisation strategies explained: maintain withdrawals), regular support (further sessions at 5 coping strategies normal relationships, make emphasised in intervention services of clinic & 10 weeks). Both positive future plans, ask (constructed by authors). questionnaires then doctors questions, keep up only (n 5 18 mailed to participants after normal routines. Patients at 6 & 12 weeks. received notebook & audio withdrawals) tape about strategies.

Study design

Consent rate (CR), response Sample size & rate (RR) characteristics

Table 1. Studies with samples including gynaecological cancer patients only

Copyright r 2008 John Wiley & Sons, Ltd. At post-test, improvement across measures for all participants. Those individually counselled had lower anxiety than others (p 5 0.02). At follow-up, both intervention groups had improved more than controls on adjustment (po0.01), depression (p 5 0.02) & anxiety (po0.01). No group differences at any time on POMS total & subscales. Intervention group more likely to have changed relationships (opposite to prediction), no other differences on coping questionnaire.

At 3 months, intervention group had better selfconcept & sexual functioning than controls (both po0.05). Only sexual functioning difference remained at 6 & 12 months (both po0.05). Advantages in employment status & other questionnaires were not significant.

Results

Similar efficacy for individual counselling and more cost-effective group counselling.

In follow-up interviews, most patients indicated that telephone counselling was helpful Allocation alternated by week of 1st treatment, not random. Small sample, particularly after withdrawals. Controls had comprehensive support program including individual counselling.

Patients in control group emphasised the lack of opportunity for discussion of sex activities during treatment.

Further comments

High loss to follow-up, partially due to deaths among participants. Lack of detail regarding analysis.

No mention of whether outcomes were assessed blind to treatment status. Lack of baseline measures for control group. Low levels of emotional distress & symptomatology may have led to floor effects.

Limitations

798 J. Hersch et al.

Psycho-Oncology 18: 795–810 (2009) DOI: 10.1002/pon


Robinson et II al. [10] (Canada)

II

1–6 months postdiagnosis, stage I–II. Age 18–70, English speaking.

CR not stated. Post-test & follow-up total RR 80%.

n 5 40. Approximately 75% cervical. Stages I-II. Mean age approximately 47 years (range 28–73).

n 5 37; 43% cervical, 27% endometrial. Stages I-II, 84% stage I. Mean age 43 years (range 18–70).

CR 35%. Four wk RR 92%. 1-2 yr RR 41%.

Counsellor. Five weekly group counselling sessions (each 1.5 h) with trained female counsellor. Treatment based on Cancer Problem Solving Instrument, included problem solving, deep muscle relaxation, weekly goal setting. Patients given relaxation tape and asked to listen twice daily. Group leaders reviewed taped sessions. Psychologist. Two psychoeducational group sessions (each 1.5 h) led by two clinical psychologists. Information booklet (same given to controls)1 handout1additional information on sexuality & cancer. Motivational component to enhance view of own sexuality.

Psychotherapist. Group psychotherapy (eight sessions, groups of five–six) including progressive muscle relaxation, roleplaying, learning by imitation, videos of cancer survivors sharing experiences. Alternatively, individual psychotherapy (4–22 sessions) with same themes as above1optional sessions with partner/ parents. Psychologist. 1 h interview n 5 83; 39% devoted to answering cervical, 37% patient’s concerns about endometrial. Stages I–III, 69% cancer and sexuality. stage I. Mean age Patients were given 4046 years (range page information booklet ‘Sexuality and Cancer’. 19–81).

n 5 90. Approximately 41% ovarian, 35% cervical. Stages of cancer not given. Mean age 49 years, range 14–70.

CR not stated. Nine mth RR 92%.

Diagnosed no more CR 70%. than 12 months ago. Post-test No previous history RR 99%. of diagnosed sexual dysfunction, no current diagnosis of mental disorder. English speaking.

In remission for at least 6 months after treatment, informed about cancer diagnosis, free of any other type of cancer. Free of manifest psychiatric pathology. Not older than 70, able to speak Dutch.

RCT: group Endometrial or psycho-education cervical cancer, stage Iprogram vs. control II, radiotherapy started. No previous history of severe sexual dysfunction. Residing within 60 miles of the cancer centre.

RCT: group counselling vs. information-only control

Quasi-experiment: pre- vs. post-brief bibliotherapeutic intervention (NB: analysis incorporated comparisons between subjects who were pre- and post-intervention but with same time since diagnosis)

Robinson et III-2 al. [24] (Canada)

Wenzel et al. [26] (USA)

Cohort study: psycho-therapy vs. control

III-2

BosBranolte et al. [25] (The Netherlands)

Psychoeducation (n 5 23), control intervention (n 5 17): information booklet11 session with counsellor

Group counselling (n 5 18), mailed information booklet only (n 5 19)

Baseline questionnaires. Intervention. Questionnaires repeated 3, 6, 9, & 12 months postdiagnosis.

Sexual History Form (sexual health), Fears about Cancer & Sexuality questionnaire, sexual knowledge questionnaire (constructed by study authors), vaginal dilation compliance1 baseline only: Profile Of Mood States, Dyadic Adjustment Inventory

Intervention reduced fears (p 5 0.01 one-tailed) but did not impact SHF scores (p40.05). Intervention improved knowledge in older patients (po0.01) and increased compliance in younger patients. Mood scores were in normal range. Most patients had happy relationships.

Intervention group had elevated mood disturbance at post-intervention (po0.01) but not at 4week follow-up. In both groups, adjustment & helplessness-hopelessness improved over time (both po0.04). No differences or changes in problemfocused coping.

Baseline SHF scores differ. Pre-morbid sexual health measured by recall. Ceiling effect for knowledge. Partners not involved. Site may confound age effects. Small sample, particularly after withdrawals.

Low consent rate. Low distress level in sample. Poor reliability of POMS (baseline data). Small sample. Very high loss to long-term follow-up.

High reading level required to understand booklet. Highly educated sample. Patients who refused to participate were significantly older than those who consented. Short intervention.

Intervention improved knowledge (po0.0001) & mood (po0.001). No effects for fears, sexual problems, communication, body image. Women evaluated intervention as helpful. Post-intervention, 83% felt they had enough information (compared to 42% pre-intervention)

Sex History Form, Profile Of Mood States, Primary Communication Inventory (communication between couples), Body Image Scale, Fears about Cancer & Sexuality questionnaire. Scales have established reliability & validity. Authors constructed questionnaires to assess knowledge, patient evaluation of intervention. Profile Of Mood States, Baseline measures. Intervention began 2 Psychosocial Adjustment to weeks later. Post-test Illness Scale, Psychological 6 weeks after pre-test Adjustment to Cancer Scale (helplessness(at close of final counselling session), hopelessness subscale), Ways of Coping Scale follow-up 4 weeks (problem-focused later, long-term subscale). All scales have follow-up 1-2 years been used in prior research, later. reliability & validity reported.

All patients received intervention

Mailed questionnaire. Intervention 1-2 weeks later. Post-test 3 months after intervention.

Self selection into groups. At baseline, patients who accepted therapy had more anxiety & depression1 lower well-being than control group. No mention of whether outcomes were assessed blind to treatment status.

Improvement of moderate problems was greater after therapy than in controls for well-being, partner relation, self-esteem, body image (all po0.05). Individual therapy patients improved more than group therapy patients (but samples too small to test this properly).

Basic Oncology Scale (constructed by authors) measuring anxiety, depression, body image, selfesteem, partner/proximity relation, general feeling of well-being. Short questionnaire evaluating psychotherapy. Semistructured in-depth interviews also conducted but data not reported.

Initial assessment: questionnaire1 interview by psychotherapist. Intervention during next 3 months. Follow-up questionnaire1 interview at 6 months (not analysed) and 9 months after initial assessment.

Patients chose group therapy (n 5 21), individual therapy (n 5 6), or none (n 5 63).

In the absence of the intervention, older women were more compliant with dilation. Fears declined over time for both groups.

Counselling may have heightened awareness & processing of feelings. Patients evaluated intervention & booklet favourably.

Most patients ‘knew’ if they needed therapy. Many said they would have preferred an earlier offer of therapy. Most group therapy patients felt eight sessions were insufficient.

Psychosocial interventions in gynaeoncology 799



II

CR 56%. One mth RR 77%. Two mth RR 58%.

Scheduled to receive CR 100%. major pelvic surgery Post-test & follow-up total RR 94%.

Undergoing treatment for metastatic or progressive disease. Experienced cancerrelated pain during last 2 weeks.

Eligibility criteria Behavioural skills component involved teaching use of dilators, lubricants, Kegel exercises. Nurse. Individualised discussion (25 min) with reference to booklet. Booklet contained information to counter eight patient-related barriers to pain management1sensory & coping information about analgesic side effects. Nurse focused on main concerns & side effects reported by each patient.

Intervention & provider

Intervention (n 5 21), usual care (n 5 22)

Comparison groups

Baseline measures. Intervention. Assessment repeated at 1 & 2 months postintervention. Participant satisfaction with the intervention was completed immediately after reading the booklet.

Study schedule (relationship happiness). Scales have established reliability.


Barriers Questionnaire (pain management barriers), Pain Management Index (adequacy of analgesic use), Medication Side Effect Checklist (analgesic side effect severity), Brief Pain Inventory (pain intensity, interference with life), Functional Assessment of Cancer Therapy (overall QOL). Scales have established reliability & validity. Participant satisfaction was also assessed. Specialist nursing EORTC QLQ prior n 5 36. Variable Nurse. Sessions at home EORTC Quality of Life sites & stages of with clinical nurse specialist intervention to surgery and at 6, Questionnaire (reliable & including cancer. Mean age (trained in psychosexual valid instrument designed 12, 24 weeks post50 years (range medicine) prior to surgery psychosexual surgery. Intervention for range of cancer 1 3 more times. Aimed intervention 15–78). patients) assessing impact began prior to to provide information & (n 5 19), of cancer & treatment on surgery and standard preemotional support, continued as needed. health, Lasry Sexual facilitate communication & trial information Lasry scale at 12 & 24 Functioning Scale for discussion, explore social Breast Cancer Patients weeks. & nursing care role, support coping (not widely tested) (n 5 17) strategies. Sexual partners assessing impact of cancer encouraged to attend. on sexual functioning & body image Hospital Anxiety & Baseline Doctor. 1 h interview with Intervention n 5 53. senior doctor involved in (n 5 26), normal questionnaires post- Depression Scale, General Approximately surgery. Intervention Health Questionnaire post-operative patient’s care (with basic 46% support services within 24 h of hospital (subscales: anxiety, training in counselling & endometrial, depression, somatisation, discharge. relaxation). Five minutes of only (n 5 27) 28% ovarian. personality development). Questionnaires relaxation music, 20 min of Stages I–III, Both scales are widely used repeated 6 weeks relaxation exercises. approximately 1considered reliable & post-surgery. Patients given written 60% stage I. valid. At baseline, outline of exercises. Mean age participants answered Remaining time spent approximately questions on social support. discussing patient’s 62 years. Intervention group also condition.

n 5 43. 56% ovarian. Advanced stage. Mean age 58 years (range 37–79).


CR 93%. RCT: counselling & Newly diagnosed, Post-test relaxation vs. recovering from RR 94%. control surgery. No psychiatric history. Able to speak English.

RCT: clinical nurse specialist intervention vs. control

II

Maughan & Clarke, [7] (UK)

Petersen & Quinlivan, [27] (Australia)

RCT: nursing intervention vs. control

II

Study design

Ward et al. [12] (USA)


Table 1. (Continued )

Both total scores lower for intervention group than controls (po0.04). Intervention reduced total HADS score1both subscales (all po0.03), as well as total GHQ score1 3 subscales (all po0.03).

Compared to controls, intervention group had significantly less anxiety about sex, less sleep disturbance, and better global health status (all po0.05). Trends for intervention group to have better functioning1more frequent & satisfying sex than controls.

No group differences for barriers, side effects, pain intensity & interference, quality of life, adequacy of analgesic use. Both groups improved in barriers & adequacy of analgesic use over time (both po0.05). Most patients (86%) found intervention helpful.

Results

Study included qualitative arm involving interviews 6 months after surgery. Central core category emerging was future disorientation. Unmet needs identified.

Most patients found intervention positive, most preferred doctor to other health professional Short intervention. Difficult to separate effect of counselling & relaxation from effect of spending time talking with doctor. Lack of longer-term follow-up.

Supplemental questionnaire sent 2 weeks after study completion: Most patients reported talking to their physician or nurse about pain management during study

Further comments

Questionable validity of Lasry scale. Lack of baseline Lasry data. Lack of detail in outcome data. More intervention patients had radiotherapy after surgery. Small sample.

Short intervention. Low consent rate - many invited patients cited excessive pain as a reason for refusing participation. Possible floor effects in outcome variables. Small sample. High loss to follow-up, partially due to deaths among participants.

Limitations




RCT: psychotherapy vs. control

II

II

Chan et al. [6] (China)

Nolte et al. [8] (USA)

II


III-1

McCorkle et al. [16] (USA)

Velji [23] (Canada)


III-1


RCT: individualised symptom education program vs. control

RCT: videotape intervention vs. control


III-1

McCorkle et al., [16] (USA)

First time diagnosis of cancer in uterus, cervix, vagina or vulva; beginning 1st

CR 72%. Baseline RR 95%. Posttest RR

n 5 142; 64% endometrial. Stages I–IV, 77% stages I–II. Mean

Videotape. 45 min instructional video of cancer patients presenting makeup techniques & suggestions on hair & headpieces. Developed by professional production company in collaboration with a study author. Positively reviewed by expert panel of 20 oncology nurses. Patients watched video at home/ clinic. Nurse. Six weekly sessions (each 20–30 min) of evidence-based symptom management

CR 100%. Post-test RR 100%.

CR 86%. Phase 1: about to begin chemotherapy, Post-test no other malignancy, RR 100%. no prior hair loss or other disfigurement, able to read English Phase 2: pronounced or total hair loss

Newly diagnosed, recovering from surgery

n 5 136. Approximately 74% ovarian. Approximately 93% stages III–IV. Mean age 58 years (range 27–80).

Contacts with oncology clinical nurse specialist & psychiatric consultation liaison nurse during 8 weeks after surgery

n 5 17. All ovarian. Stages not given. Mean age 61 years (range 35–68).

Above intervention tested for 8, 12, 16, 20, 24 weeks. Patients taught to monitor & document symptoms for review with clinic nurses. Psychologist. Individual psychotherapy with clinical psychologist. Sessions every 2 weeks throughout treatment1every 6 weeks during follow-up (up to 1.5 years). Core components: psychoeducation, supportive care, brief crisis counselling, relaxation, management of symptoms & distress.

CR not stated. Posttest RR not stated.

Recovering from surgery

Nurse. Eight contacts with oncology clinical nurse specialist within 4 weeks after surgery (two home visits, two clinic visits, four phone calls)

n 5 41. All ovarian. Variable stages. Mean age 69 years.

n 5 21. All ovarian. 73% late-stage. Mean age 64 years (range 43–90). n 5 155; 48% Newly diagnosed. No CR 97%. Baseline RR ovarian, 32% known confusion. 94%. Three cervical. Stages Age 18–70, able to I–IV, 57% stage I. mth RR understand & read Mean age 45 80%; 18 Chinese. years. mth RR 57%.

CR not stated. Post-test RR not stated.

Recovering from surgery

Intervention (n 5 70), usual care only (n 5 72)

Videotape intervention (n 5 68), only standard counselling about hair loss (n 5 68)

Specialist nurse intervention (n 5 10), no intervention (n 5 11) Psychotherapy (n 5 80), standard medical care only (n 5 75)

Specialist nurse intervention (n 5 10), no intervention (n 5 7)

Specialist nurse intervention (n 5 20), no intervention (n 5 21)

Baseline measures. Intervention (over 7–9 weeks). Post-test at end of intervention

Symptom Distress Scale, Brief Fatigue Inventory, & Brief Pain Inventory (intensity & impact

EORTC Quality of Life Questionnaire, Beck Depression & Anxiety Inventories, Impact of Events Scale, Generalised Self-Efficacy Scale, Rosenberg Self-Esteem Scale, Medical Interview Satisfaction Scale. Chinese versions used, prior evidence of reliability & validity given. Body Cathexis/SelfBCSCS prior to 1st course of treatment Cathexis Scale measuring & prior to 3rd course. body image & self-esteem Intervention. BCSCS (used in prior research on & video questionnaire body image & cancerinduced alopecia, after 4th course (exact timing relative established reliability). Intervention group also to intervention not completed a qualitative given). questionnaire on usefulness of video.

Baseline in hospital. Intervention began soon after discharge. Repeat measures 3 months post-surgery. Initial assessment questionnaires. Intervention began about 1 week later. Repeat assessment every 3 months for 18 months.

Baseline measures. Intervention. Repeat assessment at 3 months post-surgery.

Baseline measures. Intervention. Repeat assessment at 3 months post-surgery.

provided short comments of their impression of the session. Enforced Social Dependency Scale (functional status), Symptom Distress Scale, CES Depression Scale, MOS Health Survey (mental health scale). Scales are reliable & valid. Distress Thermometer (baseline), State Trait Anxiety Inventory, Symptom Distress Scale, CES Depression Scale, MOS Health Survey (physical, pain, emotional, social, mental health scales) Self-report questionnaires (details not given but presumably similar to above), chart audits

Compared to controls, worsening of symptom distress since baseline was less in intervention group

No group differences in body image or self-esteem (both p40.5). Scores were very stable over time. Most patients in intervention group reported that video was helpful in adjusting to hair loss.

8–12 weeks not long enough. Twenty weeks optimal for reducing physical & psychological distress. No group difference on any measure at any time. Both groups showed clinically significant improvements over time for overall quality of life1 most functional & symptom scales from 6 months on. Psychological status stable over time.

Outcome predicted by time since diagnosis, age, disease stage at diagnosis, education level

Patients identified uncertainty as major concern.

Baseline pain significantly higher in intervention group. Poss-

Overall distress increased to posttest, then dropped to baseline levels by

Standard counselling Short intervention received by all was taking place after hair loss had already started. probably effective No measure of overall well-being or distress. Lack of longer-term follow-up.

High loss to follow-up, partially due to deaths among participants. Low levels of anxiety & depression1high level of medical team satisfaction in unselected patients may have led to floor & ceiling effects.

Outcome data not given. Small sample.

No significant differences. Small sample. Trends for highly distressed patients to improve after intervention (p 5 0.1).

No significant differences. Small sample. Trends for highly distressed patients to improve after intervention (p 5 0.1).




RCT: coping/communicationenhancing intervention vs. supportive counselling vs. control

RCT: specialised nursing intervention program vs. attention control

II

II


Study design

Manne et al. [15] (USA)


Table 1. (Continued )

n 5 353; 81% ovarian. Stages I–IV, 56% stages III–IV. Mean age 50 years.

n 5 145; 58% ovarian. Stages I–IV, 65% stages III–IV. Mean age 61 years (range 21–86).

CR 41%. Three mth RR 84%. Six mth RR 75%. Nine mth RR 64%.

CR 68%. One mth RR 88%. Three mth RR 83%. Six mth RR 74%.

On active treatment (i.e. o3 months post-surgery or currently receiving chemotherapy or radiation). Age 181, English speaking, no hearing impairment, residing within a 2 h commuting distance from recruitment centre.

Suspected primary diagnosis of ovarian cancer, expected survival of 61 months, scheduled for surgery, planning to start chemotherapy. Age 211, residing in same state as recruitment centre.

time external beam 92%. Three age 59 years radiation therapy to mth follow- (range 26–87). pelvis, not in palliative up RR 85%. care. Age 181, able to speak & understand English.

Eligibility criteria


Coping & communication intervention (n 5 122), supportive counselling (n 5 120), usual care (n 5 111)

Comparison groups

Baseline measures. Intervention. Assessment repeated at 3, 6, & 9 months post-baseline.

(corresponding to completion of radiation therapy), follow-up 3 months later.

Study schedule subscale), Rhodes Index of Nausea & Vomiting (nausea subscale), Hospital Anxiety & Depression Scale. Prior evidence of reliability & validity given for all above. Pelvic Symptom Index (constructed by study author).


Beck Depression Inventory, Impact of Events Scale (cancer-specific distress), Emotional Expressiveness Questionnaire positive subscale, Cancer Rehabilitation Evaluation System functional subscale (physical symptoms), Expectancy Rating Form (at end of Session 1), treatment evaluation (after final session). Scales have established reliability & validity. Baseline measures 1- Centre for Epidemiological Nurse, 18 contacts (home Intervention 2 days after surgery. Studies Depression Scale, (n 5 73), visits, phone calls, clinic Symptom Distress Scale, Intervention during attention visits) with advanced Short-Form Health Survey practice nurse. Individually control (n 5 72): first 6 months after (overall quality of life hospital discharge. Symptom tailored specialised care Assessment repeated calculated from physical & Management provided: education, mental subscales). Mishel at 1, 3, & 6 months Toolkit18 symptom monitoring & Uncertainty in Illness Scale post-baseline. contacts with management, counselling, (ambiguity subscale), trained nonsupport, referrals, selfDistress Thermometer nurse symptom management skills, (baseline only). All are manager facilitation of decision standardised measures participation. Women with established reliability given Symptom & validity. Management Toolkit (same as controls).

education in private room at radiation clinic. Focus on strategies to manage symptoms identified as being of most concern for each woman in each week. Women chose strategies they wished to use from pharmacological & nonpharmacological options. Patients given one-page written guide for each symptom. Social worker/psychologist. 6 individual sessions (each 1 h)1one telephone session. CCI: Enhancing coping & supportsolicitation skills, evaluating life priorities, dealing with emotional reactions to cancer. SC: Enhancing adaptation by encouraging emotional expression, supporting existing coping behaviours, improving selfesteem.


follow-up. Intervention did not influence strategies used. Mood disturbance was most frequently reported symptom. Pelvic symptoms (e.g. diarrhoea) were of most concern.

Further comments

Treatment evaluation scores were significantly higher for coping/ com-munication intervention than supportive counselling. In the total sample, both depressive symptoms and cancer-specific distress decreased significantly over time. Overall Baseline group Compared to controls, improvement in intervention group improved differences on three more in uncertainty but less outcome variables. Low both groups over in physical health, depression consent rate. High loss time. Women in to long-term follow-up, intervention group & distress (all po0.01). partially due to deaths with significant Psychiatric referrals (n 5 distress at baseline 32) increased improvement among participants. were offered in uncertainty (p 5 0.02), additional evaluation distress, mental & physical by psychiatric health (all po0.01). consultation liaison nurse (1-2 contacts). Low consent rate. Women who refused to participate were significantly older than those who consented. 19% of women in intervention groups attended no sessions. High loss to long-term follow-up, partially due to deaths among participants.

ible floor effects for individual symptoms. Highly educated sample. Patients who left the study were less likely to be Caucasian and more likely to be of South or Southeast Asian origin.

at post-test (p 5 0.04) & follow-up (p 5 0.07). At post-test, intervention group also had nonsignificantly less worsening on all symptom scores (all p40.01).

At 9 months only, depressive symptoms were lower after supportive counselling (p 5 0.04) & coping intervention (p 5 0.06) than in controls. Effect of supportive counselling was greater in women with greater change in functional status over time. No group differences in cancer distress at any time.

Limitations

Results




database of current funded research and subsequent contact with the lead author [22]. One of the included studies, identified through electronic database searching, was reported in a doctoral thesis [23], with the remainder reported in published journal articles. In total, 22 studies met the inclusion criteria and were included in the review (see Tables 1 and 2). Three of the studies were small pilot studies conducted by one research team and reported together in a single article [16]. Thus, the 22 studies were reported in 20 separate papers.

Study characteristics Of the 22 included studies, 18 were RCTs of interventions. One controlled trial used a pseudorandom allocation method [14], one study used a quasi-experimental pre-/post-intervention design (with comparisons between subjects who were pre- and post-intervened) [24], and the remaining two were cohort studies [9,25]. With one exception [26], most participants were recruited from hospitals or cancer centres. Two studies recruited patients from 10 or more institutions [8,15], 4 studies used two or three hospitals [23,27,28,29], and the remaining 15 studies were based in single hospitals or cancer centres. Sample sizes varied from 17 to 353, however most samples were small. Only one study included more than 200 participants [15], and an additional four had more than 100 participants [6,8,22,23]. All but one study [9] reported the mean age of patients and this varied from 43 to 69 years. There was one Chinese sample, one Spanish sample, and one Latin-American sample, however most studies (n 5 11) reported majority-Caucasian samples. Eight studies did not report data on ethnicity. Four studies [28,29,30,31] included women with either breast cancer or gynaecological cancer (proportion ranged between 39 and 71%) (see Table 2). The remaining 18 studies included only participants with gynaecological cancer (see Table 1). One of these studies did not report any information on cancer sites among patients [14]. Three studies—reported in a single article— included women with ovarian cancer only [16]. However, most studies contained patients with mixed sites of cancer (n 5 14). Six studies consisted primarily of women with ovarian cancer, four cervical, and three endometrial cancer. Stages in most samples were mixed, with earlier stages (I & II) predominant, although six studies did not provide sufficient detail regarding disease staging. One study separately evaluated two different styles of intervention in a three-group design [15], therefore this study was considered to contribute two interventions to the review. Interventions incorporated a range of different components. One reported a trial of an energy-based complementary therapy (healing touch) believed to exert Copyright r 2008 John Wiley & Sons, Ltd.

803

positive effects by influencing energy fields [30], and one intervention was purely supportive in nature [15]. All other interventions included either information provision (n 5 17) or coping strategies such as problem solving and relaxation techniques (n 5 14) or both (n 5 10). In many of the studies that included information or education, this component of the intervention was tailored to the needs of individual patients. Encouragement of emotional expression and general support were other common elements of several interventions. Nurses and psychologists were the most common intervention providers. Although most studies integrated multiple components into their psychosocial treatment, the interventions were categorised according to their primary features. Cognitive-behavioural interventions formed the largest category (n 5 11) and were characterised by a focus on changing unhelpful thoughts or behaviours or on learning coping skills [6,9,10,14,15,16,25,26,28,29,31]. Seven interventions were best described as counselling or psychotherapy [7,15,16,22,27,32], whereas four were primarily educational, based on the provision of information to patients [8,12,23,24]. The healing touch intervention [30] was categorised as ‘other’. Most studies utilised multiple instruments to measure multiple outcomes. In total, 50 different instruments were employed across the sample. Emotional adjustment was assessed in all studies. Symptoms of depression or anxiety or overall psychological distress were measured in all but one study [8]. Other aspects of emotional adjustment included body image, self-esteem, and satisfaction with medical care. Apart from emotional adjustment, the other main type of outcome was functional adjustment (n 5 16). These measures were used to assess patients’ ability to function in various aspects of everyday life, such as social, physical, sexual, marital, and vocational domains. In addition to measures of emotional and functional adjustment, six studies also included measures of pain or side effects associated with disease or treatment [6,12,16,23,29,30].

Study quality Of the 18 RCTs, 12 reported using an adequate randomisation method to allocate participants to treatment groups. The remaining six trials [8,10,15,16] claimed randomisation but either failed to describe an appropriate technique or failed to document group similarity at baseline. Most studies used self-report questionnaires as their main outcome measures. Owing to the nature of the interventions, proper blinding of participants was generally not possible. However, the study of healing touch [30] included a mock-treatment control condition, where all participants were Psycho-Oncology 18: 795–810 (2009) DOI: 10.1002/pon


III–1

n 5 94 couples; 39% gynaecological (mainly cervical), 61% breast. Stages I–III, but mainly stages I–II. Mean age of women 51 years.

CR 94%. Post-test RR 90%. Six mth followup RR 83%. Twelve mth follow-up RR 70%.

Early stage cancer, about to begin treatment, no other cancer history. No treatment for psychological disorder in past year, married or in committed relationship for 121 months. Living in or near the city, able to read and speak English.

n 5 55. 51% CR 68%. Baseline RR cervical, 49% 96%. Post- breast. Stages

n 5 78. Approximately 61% gynaecological (mainly cervical, endometrial), 39% breast. Stages I–IV, but mainly stages I–II. Mean age approximately 51 years.

CR 35%. Post-test RR 79%.

Newly diagnosed, having radiation therapy, condition unlikely to rapidly deteriorate. No prior experience of healing touch. Age 17 1, able to read English, not cognitively impaired.

Eligibility criteria

31 months since RCT: collaborative diagnosis, not in palliative care. care

RCT: couplebased coping training vs. individual coping training vs. medical education

II

Scott et al. [28] (Australia)

DwightJohnson

RCT: healing touch vs. mock treatment

II

Study design

Cook et al. [30] (USA)



Social worker/doctor. Initial clinical assessment 1 education session with

Certified HT provider. Six half-hour sessions of healing touch, held weekly at medical centre after radiation (4 week gap before final session). Patients lay on massage table with opaque screen between head & body to prevent view of provider’s identity & actions. Video monitoring to check integrity of treatment. Psychologist. Five sessions (each 2 h) of couple coping training at home12 phone calls (each 30 min). Therapy integrated medical information with coping education & supportive counselling. Couples received sexual counselling and were taught supportive communication & partner support.


Table 2. Studies with samples including gynaecological cancer and breast cancer patients

Baseline measures presurgery. Intervention (from pre-surgery to 6 months later). Repeat measures postintervention and at 6 months. All assessments except couple communication also repeated at 12 months.

Baseline sociodemographic interview 1 questionnaire assessment. Intervention. Repeat of questionnaire assessment (exact timing not given).

Study schedule MOS Health Survey (measuring activity limitations, pain, mental health, vitality, health perceptions, health transition; established reliability & validity). Short questionnaire on attitude to healing touch (at baseline), question on belief about group assignment (at end).


Dyadic Adjustment Scale (baseline), Psychosocial Adjustment to Illness Scale (psychological distress & sexual difficulties), Ways of Coping Questionnaire. Women also completed Impact of Events Scale, Sexual Self-Schema Scale, Self-Image Scale, Brief Index of Sexual Functioning. Scales have established reliability & validity. Couple communication assessed via videotaped discussion. Client satisfaction was also assessed. Personal Health Collaborative care Baseline assessment. Intervention. Follow-up Questionnaire (depression), (n 5 28), usual assessments at 4 & 8 Functional Assessment of care (n 5 Couple-coping training, individual coping training, medical information education (n 5 approx 30 each). All provided by experienced registered psychologist.

Healing touch (n 5 44), mock treatment (n 5 34): for this group, lay person stood and walked around patient’s body with hands at sides (same schedule as intervention group)

Comparison groups

More improvement in depressive symptoms & emotional well-being 1

Benefits of couple training in coping effort, avoidance, sexual self-schemas, perceived partner acceptance of body image, sexual intimacy (all po0.05). Couple training improved couple coping in communication (po0.05). No group differences in satisfaction with service & therapist.

No group difference in overall score (p40.05). Mean improvement for intervention group in overall score 1 health transition, emotional role functioning, mental health (all po0.04). Control group improved in physical role functioning, health transition (both po0.02).

Results

Unclear which elements of training produced the effect. At baseline, 72% of gynaeco-logical cancer patients reported cancer-related cessation of sex.

Dropout rate significantly higher among gynaecological cancer patients than breast cancer patients. At end of study, most patients believed they had received healing touch.

Further comments

Low consent rate. Participants were lowincome Latinas, most Baseline group differences in well-

Inadequate power. High loss to long-term follow-up. Dropouts were less maritally satisfied and showed less warmth in baseline discussion.

Low consent rate. High loss to follow-up. Dropouts more highly educated than others. Lack of longer-term follow-up. Trend for higher baseline scores in intervention group.

Limitations



RCT: relaxation & guided imagery training vs. control

LeońPizarro et al. [29] (Spain)

II

(therapy or medication) vs. control

et al. [31] (USA)


About to be hospitalised for brachytherapy treatment

Depressed but not suicidal, no history of bipolar disorder or psychosis, no current drug abuse, no current psychotherapy. Cognitively unimpaired, able to speak Spanish or English.

CR 68%. Post-test & follow-up total RR 73%.

test & follow-up total RR 65%.

n 5 90. 71% gynaecological, 29% breast. Stages I–IV, 85% stages I–II. Mean age 54 years (range 24-82).

I–IV. Mean age 47 years.

Provider not stated. Information about brachytherapy, exploring fears, clarifying doubts (45–50 min individual session, same as controls). Intervention group also received 10–15 min training in relaxation & guided imagery1individualised cassette recording. Instructions included headto-toe relaxation, breathing techniques, descriptions of pleasing images (preselected by patients), description of treatment process.

social worker. Patients chose antidepressants or problem-solving therapy. Therapy (8 weekly sessions with social worker) based on cognitive behaviour theory. Antidepressants initiated in conjunction with oncologist who provided medication follow-up.

Relaxation & guided imagery training (n 5 32 after withdrawals), information control (n 5 34 after withdrawals)

27): patients informed of depression diagnosis 1 usual mental health resources available

Cancer Therapy Scale (functional status, quality of life), treatment adherence 1 baseline only: Personal Health Questionnaire (anxiety), Karnofsky Performance Status Scale (functional status), Hispanic Stress Inventory, items to assess knowledge of depression & barriers to care. Assessments were by telephone. Scales have established reliability & validity. Hospital Anxiety & Baseline assessment. Intervention 1-2 weeks Depression Scale (Spanish prior to hospitalisation. version), Cuestionario de Post-test on day 2 of Calidad de Vida (self-report hospitalisation, follow- quality of life questionnaire with subscales: body up 2–3 weeks after discomfort, psychosocial brachytherapy (at disorders). A Visual hospital follow-up Analogue Scale was used to visit). assess pain (post-test only), support from relatives & satisfaction with support (baseline only). All scales have established reliability & validity. months. Patients in intervention group were also contacted at least every 2 weeks to assess depressive symptom severity, medication adherence, & side effects.

Compared to controls, intervention reduced anxiety, depression, body discomfort (all po0.05), psychosocial disorders (p 5 0.06). Pain correlated with anxiety, support correlated negatively with depression.

higher survival in intervention group (all po0.05). No group difference on change in overall quality of life scores (p 5 0.13). Trend for better cancer treatment adherence in intervention group (p 5 0.08).

Low consent rate. Short intervention. High loss to follow-up.

On pain scale, gynaecological cancer patients had higher mean, range, & standard deviation of scores than breast cancer patients. Frequent patient complaints included lack of information on treatment, sensation of isolation during hospitalisation.

being. High loss to with Spanish as primary follow-up; 18% of language intervention group received no services. Two distinct types of intervention not analysed separately.



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blinded to their condition using an opaque screen that prevented them from viewing their own body and the actions of the provider. In one study, communication between patients and partners was assessed using a videotape recording of a conversation and scoring was performed blind to intervention condition [28]. However, of four studies that included outcome assessment via interviews, only two stated that interviewers were blind to the intervention condition [31,32]. Three studies failed to state whether any loss to follow-up occurred [9,16]. In 15 of the remaining 19 studies, at least 80% of participants provided some post-intervention data. Rates of completion of subsequent follow-up assessments varied widely among the studies. However, 10 papers reported substantial loss to follow-up (completion rates ranging from only 41 to 79%). Differential dropout was evident in two studies [28,30], potentially leading to selection bias. In one study involving a couple-based intervention, couples who withdrew from the study were less maritally satisfied and displayed less warmth in their communication at baseline than did those who completed the trial [28]. In the other study, participants who dropped out were more highly educated than those who remained in the trial [30]. Selection issues were another potential source of bias for a number of studies. Three studies achieved consent rates of less than 45% [15,26,30], and a further four studies reported consent rates below 70% [12,22,29,31]. In one study that assessed pain as a main outcome variable, many of the invited patients cited excessive pain as a reason for refusing to participate, meaning that the results may not generalise to those in the population with more severe pain [12].

Outcomes Psychological distress

There was evidence from one randomised controlled trial that healing touch reduced limitations in usual role activities due to emotional problems [30]. This study was generally well designed, but the very low consent rate (35%) and the fact that noncompleters tended to be highly educated are sources of concern in terms of the generalisability of findings. Velji’s randomised controlled trial demonstrated benefits of symptom education for participants’ symptom distress [23], while results reported by Robinson et al. provide some evidence that information on cancer and sexuality improved women’s mood [24]. Evidence regarding the impact of counselling interventions on distress was mixed. Four RCTs reported no change in levels of distress [7,15,16]. However, a better quality study showed that Copyright r 2008 John Wiley & Sons, Ltd.

J. Hersch et al.

distress was reduced after thematic counselling in either individual or group format [32]. A more recent RCT demonstrated benefits of a specialised nursing intervention on patients’ sense of uncertainty [22]. Similarly, trials of cognitive-behavioural interventions yielded mixed results. A well-conducted RCT found that women who received coping training together with their partners experienced improvement in their psychological distress levels [28]. Training in relaxation and guided imagery appeared to be somewhat beneficial to women’s emotional status [29]. However, other level II evidence did not support any benefit from cognitive-behavioural interventions [6,15,26]. Level III studies also provided mixed evidence, with two positive [25,31] and two negative results [9,14]. Depression and anxiety

Two good-quality RCTs showed that counselling interventions reduced symptoms of depression and anxiety [27,32]. However, the intervention conducted by Petersen and Quinlivan [27] was unusual in that it was provided by a senior doctor involved in the patient’s care. This makes it difficult to know whether the success of the intervention was due to the content of counselling or simply the rare opportunity to spend time alone and uninterrupted with the doctor in a quiet and relaxed environment. In further level II evidence, supportive counselling reduced depressive symptoms [15]. Another study evaluating a specialised nursing intervention found that depressive symptoms improved over time across both the intervention and control groups, but no additional benefit was conferred by the intervention itself [22]. Two small pilot studies of counselling by oncology nurse specialists for ovarian cancer patients also failed to find any significant results, although one reported a trend for highly distressed patients to improve in depressive symptoms [16]. Evidence regarding the effectiveness of cognitivebehavioural interventions on reducing depression and anxiety symptoms is less clear. Three RCTs reported benefits for anxiety [10,29] and depression [15,29], and one pseudo-RCT found benefits for depression [31]. However, four other trials of cognitive-behavioural interventions (evidence levels II and III) failed to detect any improvement in these symptoms [6,9,25,26]. An information-based intervention was also found to have no effect on patients’ fears [24]. Self-esteem, body image, attitude to medical care

One good-quality RCT found no evidence for an information-based intervention improving self-esteem and body image [8], consistent with a methodologically weaker study of an informationbased intervention [24]. Similarly, in RCTs Psycho-Oncology 18: 795–810 (2009) DOI: 10.1002/pon


neither counselling [7] nor cognitive-behavioural interventions [6,28] improved self-esteem or body image. However, two cohort studies of cognitive-behavioural interventions provide level III-2 evidence for significant benefits in self-esteem and body image [9,25]. Individual and group counselling were shown to improve patients’ general attitude towards their health care in one well-conducted RCT [32]. However, other studies found informational [12] or cognitive-behavioural interventions [6,26,31] had no impact on attitudes towards medical care.

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tioning reported any benefit of the intervention as determined by differences between intervention and control groups [29], in spite of the fact that the interventions in the aforementioned studies were carried out with patients who were in the treatment phase and therefore at a time of high symptom load. The three cognitive-behavioural or counselling intervention studies assessing vocational functioning also failed to find any beneficial intervention effects [9,26,32]. Physical symptoms

Social and sexual functioning

Ten studies, including interventions spanning all four categories (cognitive-behavioural, counselling/ psychotherapy, educational, and other), assessed social functioning. This involved the attempt to index the extent to which the patient’s social activities had been disrupted by her cancer. Of the 10 studies, only one statistically significant positive result was reported (level II evidence). In this RCT [32], patients who received individual or group thematic counselling experienced less disruption of their social environment and leisure activities than controls six months after the intervention. However, 25% of participants were lost to follow-up, and the same effect was not evident in the more complete data collected immediately after counselling. Two studies reported level II evidence that counselling was beneficial to sexual functioning or satisfaction [7,32]. Both of these studies incorporated discussion of treatment effects on sexual functioning into their interventions. Of the four trials of cognitive-behavioural interventions that included sexual functioning outcome measures, two reported positive results [7,28] and two did not [10,26]. The successful RCT [28] engaged patients in coping training together with their partners. Finally, a quasi-experimental trial of an intervention based around providing information on cancer and sexuality did not demonstrate any benefit to sexual functioning [24]. Physical and vocational functioning

Seven studies [6,12,16,22,29,30,31], including interventions spanning all four categories (cognitivebehavioural, counselling/psychotherapy, educational, and other), incorporated an outcome measure assessing functional adjustment in the physical domain. It is important to note that some samples included progressively ill patients. Therefore, a positive result in favour of the intervention could occur in the form of either (a) more improvement over time in intervention participants than controls or (b) less deterioration over time in intervention participants than controls. However, only one of the studies measuring physical funcCopyright r 2008 John Wiley & Sons, Ltd.

A relaxation and guided imagery intervention reduced symptom-related body discomfort [29]. However, no positive results were reported in the other five studies assessing the impact of various types of interventions on the physical symptoms associated with cancer or treatment side effects [6,12,16,23,30].

Discussion The evidence regarding the effectiveness of the reviewed psychosocial interventions on overall psychological distress was inconclusive. One study suggested that healing touch was effective, but the results from trials of cognitive-behavioural and counselling interventions were mixed. However, there was limited evidence that psychoeducation could improve mood or distress, whereas symptoms of depression and anxiety seemed to be amenable to counselling. There was limited evidence that counselling also improved satisfaction with medical care and that self-esteem and body image benefited from cognitive-behavioural interventions. The positive effects of cognitive-behavioural and counselling interventions on emotional adjustment are consistent with the results of an earlier meta-analysis of psychosocial interventions with cancer patients [33]. Very little evidence was found for benefits attributable to any intervention type on physical symptoms or on functional adjustment in physical, vocational, and social domains. These results are in line with those of a large-scale review of psychological interventions in the general oncology population, which also failed to make any firm recommendations about interventions for physical symptoms, vocational adjustment, or social relationships [19]. In terms of sexual functioning, however, the earlier general review found no intervention that could be recommended for improving sexual functioning [19] whereas in the current review, sexual functioning results were mixed for cognitive-behavioural interventions and more positive for counselling. This discrepancy may reflect the particular relevance of sexual concerns for women with cancers directly affecting Psycho-Oncology 18: 795–810 (2009) DOI: 10.1002/pon

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their sexual organs, with interventions often exploring these issues in some depth.

Quality of the evidence The 22 reviewed studies included approximately 1900 women with gynaecological cancers. Methodological quality varied, but every study had its limitations (see Tables 1 and 2). A common weakness was a small sample size, with 10 studies having fewer than 60 participants, thus limiting their power to detect intervention effects. Many studies also reported high (420%) loss to followup, potentially introducing selection bias into the results. Low consent rates (o70%) were another possible source of selection bias. In some studies, intervention and control groups differed at baseline with regard to important variables such as wellbeing, sexual health, anxiety, and depression, making accurate comparisons difficult. Floor and ceiling effects on some outcome measures were also of concern. Considering that intervention studies commonly involve small sample sizes, future studies would benefit from screening procedures enabling the targeting of only those participants who are in need of the proposed interventions (i.e. those with unmet needs, psychological distress and/ or lower QoL) in order to maximise the power of the study and to minimise floor effects. In addition, a number of studies included just one post-intervention assessment without attempting to investigate any longer-term effects of the interventions [8,16,24,27,30]. Furthermore, there was a high degree of inconsistency between results of different studies, even when testing similar interventions and using similar outcome measures. Therefore, it was difficult to draw robust conclusions based on the available evidence.

Limitations Bias at the data extraction stage of the review process was reduced by developing a study review template that was then used by two independent reviewers to extract key data from each study. However, although some effort was made to identify ‘grey literature’, including through personal contact with experts in the field, this review relied primarily on published studies and hence may be subject to publication bias. In addition, there may be relevant studies published in languages other than English that have not been indexed by the bibliographic databases employed here. The reviewed research involved participants at various periods of the illness trajectory. However, it was not possible to conduct analyses on subgroups of studies according to participant characteristics such as disease stage and treatment phase. This was because of the relatively small Copyright r 2008 John Wiley & Sons, Ltd.

J. Hersch et al.

number of studies that were eligible for inclusion and also because of the great variety within and between the samples. No patterns were identified linking intervention success to any sample variables. The conclusions below are therefore intended to be relevant to women with gynaecological cancers as a general group.

Conclusions Further research is needed to clarify whether psychosocial interventions enhance QoL for women with gynaecological cancers and to identify what types of interventions are most effective. In designing intervention studies, researchers need to be mindful of the factors that may influence QoL in this population. RCTs are the gold standard design for evaluating interventions [21], which is reflected in a clear predominance of this type of study in the literature published since 1990. However, future studies need to aim to recruit larger numbers of participants in order to (a) reduce the probability of important baseline group differences arising due to chance; (b) allow for analyses involving subsamples (e.g. women who are sexually active); and (c) help offset loss to follow-up. However, even though longer-lasting studies are almost inevitably subject to some loss of participants, it is nonetheless worthwhile to conduct multiple postintervention assessments in order to obtain a comprehensive picture of patient outcomes and any long-term effects associated with interventions. Sometimes, positive outcomes may be more evident in the long term than immediately after the intervention [15,32]. Additionally, future research should address possible influences of ethnicity by evaluating intervention effects on QoL among women who are culturally and linguistically diverse. There is also a need for better reporting of intervention studies. It is important to provide a complete description of the sample, including the age range and stages of cancer among participants. The proportion of invited patients who consented to participate and the proportion of the initial sample that provided post-intervention outcome data serve as a guide to how representative of the general patient population the sample is likely to be. Therefore, consent rates and the extent of loss to follow-up should be routinely reported. Finally, accurate evaluation of trials is facilitated when authors provide complete details of their analysis and results, including group means and test statistics for specific comparisons. Three very brief interventions (single sessions lasting 1 h or less) based primarily on imparting helpful information to patients were largely unsuccessful in enhancing their targeted QoL outcomes [8,12,24]. Another psychoeducational Psycho-Oncology 18: 795–810 (2009) DOI: 10.1002/pon


intervention had more success [23], but this program involved six contacts with an advanced practice nurse, meaning there was arguably an important supportive component in addition to information provision. Therefore, although psychoeducation was a component of most of the reviewed interventions, the evidence suggests that information alone is not sufficient to bring about positive changes in QoL for gynaecological cancer patients. However, it may be that the psychoeducational interventions reviewed here did not incorporate long enough follow-up periods to detect benefits that may have become apparent at 6 months or more post-intervention, as suggested by a previous review [19]. Healing touch may positively influence healthrelated QoL, but the evidence is very limited, coming from just one study with a sample of questionable representativeness [30]. Cognitivebehavioural interventions may improve self-esteem and body image [9,25], but other possible benefits remain unclear. From this review, the strongest implications for clinical practice are regarding counselling interventions. The evidence suggests that such interventions may be beneficial to women with gynaecological cancers with respect to their sexual functioning, symptoms of depression and anxiety as well as psychological distress in general, and attitudes towards health care [7,15,22,27,32].

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