Long-term outcome after colorectal cancer resection ...

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Jan 29, 2007 - Long-term outcome after colorectal cancer resection. Patients' self-reported quality of life, sexual dysfunction and surgeons' awareness.
Tumori, 94: 30-35, 2008

Long-term outcome after colorectal cancer resection. Patients’ self-reported quality of life, sexual dysfunction and surgeons’ awareness of patients’ needs Francesco Di Fabio1, Michael Koller2, Riccardo Nascimbeni1, Carlo Talarico1, and Bruno Salerni1 1

Cattedra di Chirurgia Generale, University of Brescia School of Medicine, Brescia, Italy; Center for Clinical Studies, University Hospital Regensburg, Regensburg, Germany

2

ABSTRACT

Aims and background. Current follow-up care programs focus mainly on detection of tumor recurrence or metachronous cancer. Other aspects that affect the quality of life (QoL) of long-term survivors, such as sexual dysfunction, psychological distress or depressive symptoms, have been poorly investigated. We studied these issues, and also investigated the surgeons’ awareness of their patients’ needs in order to determine how to improve follow-up care programs. Methods. QoL of 62 colorectal cancer patients was assessed during follow-up using the European Organization for Research and Treatment of Cancer (EORTC) questionnaire QLQ-C30 and the symptom-specific module (QLQ-CR38). Postoperative sexual problems were evaluated with a 6-item questionnaire. Relevant needs to be examined during follow-up were investigated among patients and surgeons, by filling in the same checklist. Results. During long-term follow-up (range,14-74 months), rectal cancer patients reported lower QoL than colon cancer patients regarding defecation-related problems (P = 0.0001). Sixty-one percent of colon cancer patients reported no sexual dysfunction, whereas only 24% of individuals with rectal cancer reported no problems (P = 0.007). Patients reporting no sexual problems had significantly better QoL than the others, particularly with respect to physical functioning (P = 0.001), social functioning (P = 0.05), financial problems (P = 0.01) and body image (P = 0.0001). Addressing emotional problems during follow-up was important for 26% of the patients, while this was neglected by surgeons (P = 0.03). Conclusions. QoL measurement in a clinical setting may help to detect QoL problems that could otherwise go unnoticed in the routine of follow-up care. Specifically, it was useful to detect defecation-related problems, sexual dysfunction and a mismatch in judging the importance of psychological distress between patients and their doctors. Neglecting these issues may cause long-term postoperative dissatisfaction.

Introduction Colorectal cancer is a major health problem in industrialized countries. In Europe, almost 150,000 new cases are observed every year1. Recent data show that the 5-year survival exceeds 60%, implying that many patients will require extended follow-up after surgery2. Current follow-up care programs focus mainly on detection of tumor recurrence or metachronous cancer. Other aspects, such as sexual dysfunction, psychological distress or depressive symptoms, which are relevant for long-term survivors in that they

Key words: colorectal cancer, outcome, quality of life, sexual dysfunction. Correspondence to: Francesco Di Fabio, MD, Cattedra di Chirurgia Generale, University of Brescia School of Medicine, Viale Europa 11, 25123 Brescia, Italy. Tel +39-030-3995614; fax +39-030-3700472; e-mail [email protected] Received January 29, 2007; accepted May 30, 2007.

QUALITY OF LIFE IN COLORECTAL CANCER SURVIVORS

affect their quality of life (QoL), have been poorly investigated3-8. This limitation probably originates from a “mechanistic” concept of outcome, based on the analysis of easily observed clinical variables3,9. In addition, the practical relevance of current QoL assessment is yet to be fully explored. The diagnosis and treatment of colorectal cancer has dramatic effects on patients’ QoL, particularly during the early postoperative period10. In contrast, studies show that long-term survivors of colorectal cancer without major comorbidities or recurrence seem to experience only minor deficits in overall QoL. This may be explained by the fact that relevant areas such as sexual dysfunction are often omitted in conventional QoL assessment11. Implementation of QoL concepts in clinical practice is relevant only if it helps clinicians to understand their patients’ perspective and to improve patient care12. For this reason, in order to identify ways to improve the existing follow-up care program, we analyzed patients’ self-reported QoL during long-term follow-up, and investigated the surgeons’ awareness of their patients’ needs.

Patients and methods

31 Table 1 - Patient characteristics Variables Age (years) Mean ± SD Range Gender Male Female Months since operation Mean ± SD Range

N = 62

61.6 ± 9.3 45-77

36 26

37.2 ± 18.8 14-74

Tumor location Colon Rectum

41 21

UICC cancer stage I (pT1-2, N0, M0) II (pT3-4, N0, M0) III (all pT, N+, M0)

14 24 24

Adjuvant therapy Yes No

41 21

Education Compulsory Advanced vocational University

44 15 3

Study design and population A cross-sectional study was performed between November 2002 and November 2003 in the 1st Department of General Surgery at the University of Brescia School of Medicine, which has a high volume of colorectal diseases. The patients recruited for the study (Table 1) underwent colon or rectal resection for carcinoma at least 1 year previously, and agreed to participate in the follow-up program. The 1-year cutoff was chosen in order to avoid the specific effect of the early postoperative period on QoL. Patients with the following criteria were excluded from the study: cancer recurrence, remaining stoma, familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, inflammatory bowel disease, mental inability to fill in a questionnaire, and age over 80. The study was approved by the local Institutional Review Board, and informed written consent was obtained from all patients.

QLQ-C30 is a validated cancer-specific QoL questionnaire composed of 1 global QoL scale, 5 functional scales (assessing physical, role, emotional, cognitive and social functioning) and 9 symptom scales (measuring fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties). The cancer-specific module QLQ-CR38 addresses issues specifically related to colorectal cancer, such as defecation-related problems, gastrointestinal tract symptoms, and weight loss. To investigate patients’ needs in the course of followup, we designed an additional questionnaire to focus on clinical and QoL issues (e.g., emotional distress, expectations) (Table 2). The face validity of this new questionnaire was established in a sample of patients and surgeons, and was found to be satisfactory18.

Patients’ QoL and needs

Evaluation of surgeons’ judgment of patients’ needs

Patients’ QoL was assessed by means of the European Organization for Research and Treatment of Cancer (EORTC) questionnaire QLQ-C30 (version 3.0)13,14 and the symptom-specific module (QLQ-CR38)15. Sexual dysfunction was assessed using a separate 6-item questionnaire that had proved to be suitable in earlier studies11,16. This separate questionnaire was added because the items on sexuality in the symptom-specific module (QLQ-CR38) are poorly accepted by patients17. The

The patients’ need scale (Table 2) was also completed by all 14 general surgeons working at the 1st Department of Surgery of the University of Brescia (excluding the principal investigator (FDF)). Surgeons’ age range was 35 to 61 years and the male:female ratio was 12:2. The surgeons’ task in filling out the needs scale was to identify what they perceived were issues that should be addressed in a routine examination in order to assess patients’ needs.

32

F DI FABIO, M KOLLER, R NASCIMBENI ET AL

Table 2 - Needs of patients during follow-up care program as reported by patients (N = 62). Patients could mark up to 3 most important needs in a closed-answer fashion. Surgeons (N = 14) guessed what they thought were the patients’ 3 most prevailing needs Question: In your experience, what are the main issues that should be assessed by a surgeon during follow-up, after colorectal cancer resection? 1. Making sure there are no signs of disease recurrence (local recurrence, liver or lung metastases)

Surgeons’ estimates of patients’ preferences

Patients’ preferences

100%

89%

2. Making sure the lab exams are within the normal range (Hgb, WBC, liver enzymes, CEA, CA 19-9)

50%

69%

3. Evaluating whether patient has defecation problems (diarrhea, incontinence, constipation)

36%

21%

4. Evaluating the condition of the abdominal wound (infection) and of the abdominal wall (postoperative hernia)

7%

19%

36%

21%

6. Evaluating whether the patient has digestive problems (dyspepsia, nausea, vomiting)

7%

16%

7. Evaluating whether the patient has sexual problems

0

3%

8. Evaluating whether the patient feels that he/she is being treated like a sick person

0

8%

5. Evaluating whether the patient has pain

9. Evaluating whether the patient feels unpleasant emotional states (anxiety, restlessness, depression, low self-esteem)

0

26%*

10. Making sure the patient has a good social life

21%

10%

11. Making sure the patient has no limitations in his/her everyday activities

14%

8%

12. Evaluating whether the patient has good or bad expectations for the future

29%

10%

*P = 0.03, Fisher’s exact test.

Demographic and clinical characteristics

Results

The following demographic and clinical variables were recorded: age, gender, level of education, months since operation, tumor location (colon vs rectum), tumor stage according to the UICC classification19, permanent stoma, neoadjuvant or adjuvant therapy (Table 1).

Patient characteristics

Course of the study Each patient was seen individually by the main investigator (FDF), who explained the purpose of the study. The procedure took place in the 1st Department of Surgery, in a quiet location providing adequate privacy. The investigation started with a basic physical examination, and then the patient completed the questionnaires in privacy. The results of the physical examination, laboratory tests and imaging studies (performed prior to the appointment) were then discussed. Lastly, the patients’ comments on the questionnaires were reviewed. The entire procedure took approximately 45 minutes.

Sixty-nine patients were initially eligible for the study. Seven patients were excluded: 1 (UICC stage III) patient had carcinoma associated with ulcerative colitis, 3 had permanent stomas, 2 developed cancer recurrence and 1 (UICC stage IV) refused to take part in the study. Thus, 62 patients were included in this analysis. The characteristics of the study sample are shown in Table 1. Compliance with completing the questionnaire Patients took an average of 10 minutes to fill in the questionnaires (range, 5-32 minutes). Patients with compulsory education took longer than those with an advanced vocational or university degree (mean of 11 vs 8 vs 7 minutes, respectively; P = 0.025, Kruskal-Wallis test). The proportion of missing answers in the EORTC questionnaires was minimal (0.2%). None of the subjects had difficulty understanding or filling in the questionnaires.

Statistical analysis Quality of life scores were computed according to the EORTC scoring manual20. Mann-Whitney or KruskalWallis tests were used to compare continuous variables. Chi-square or Fisher’s exact tests were applied for analysis of categorical variables. The level of statistical significance was set at P