Accepted Manuscript Measuring the psychosocial dimensions of quality of life in advanced cancer patients: Psychometrics of the German Quality of Life at the End of Life–Cancer–Psychosocial (QUAL-EC-P) Questionnaire Britta Grünke, MSc, Rebecca Philipp, MSc, Sigrun Vehling, PhD, Katharina Scheffold, MSc, Martin Härter, Prof, MD, PhD, Karin Oechsle, Prof, MD, Frank SchulzKindermann, PhD, Anja Mehnert, Prof, PhD, Christopher Lo, PhD PII:
S0885-3924(17)30637-1
DOI:
10.1016/j.jpainsymman.2017.11.006
Reference:
JPS 9634
To appear in:
Journal of Pain and Symptom Management
Received Date: 24 August 2017 Revised Date:
3 November 2017
Accepted Date: 4 November 2017
Please cite this article as: Grünke B, Philipp R, Vehling S, Scheffold K, Härter M, Oechsle K, SchulzKindermann F, Mehnert A, Lo C, Measuring the psychosocial dimensions of quality of life in advanced cancer patients: Psychometrics of the German Quality of Life at the End of Life–Cancer–Psychosocial (QUAL-EC-P) Questionnaire, Journal of Pain and Symptom Management (2017), doi: 10.1016/ j.jpainsymman.2017.11.006. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT Article type:
Brief Methodological Report
Title: Measuring the psychosocial dimensions of quality of life in advanced cancer patients: Psychometrics of the German Quality of Life at the End of Life–Cancer–
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Psychosocial (QUAL-EC-P) Questionnaire Authors: Britta Grünke, MSc1, Rebecca Philipp, MSc1, Sigrun Vehling, PhD1,2,3, Katharina Scheffold, MSc1, Martin Härter, Prof, MD, PhD1, Karin Oechsle, Prof, MD2,3, Frank SchulzKindermann, PhD1, Anja Mehnert, Prof, PhD4, Christopher Lo, PhD5,6,7
Department of Medical Psychology, University Medical Center Hamburg-Eppendorf,
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1
Hamburg, Germany
Department of Oncology, Hematology and Bone Marrow Transplantation with section of
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2
Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany 3
University Cancer Center Hamburg (UCCH) – Hubertus Wald Tumor Center, University
Medical Center Hamburg-Eppendorf, Hamburg, Germany 4
Department of Medical Psychology and Medical Sociology, University Medical Center
Leipzig, Germany
Department of Supportive Care, Princess Margaret Cancer Centre, University Health
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5
Network, Toronto, Canada
Department of Psychiatry, University of Toronto, Toronto, Canada
7
Department of Psychology, University of Guelph-Humber, Toronto, Canada
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6
Corresponding author:
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Rebecca Philipp, M. Sc. Psych.
Department of Medical Psychology University Medical Center Hamburg-Eppendorf Martinistr. 52 - W26
20246 Hamburg, Germany
Phone: ++49 40 7410 56203 Fax: ++49 40 7410 54940 E-Mail:
[email protected] Number of tables: 3, Appendix: 1 Number of references: 42 Word count: 2,473
ACCEPTED MANUSCRIPT Abstract Context: Quality of life is a central focus of care in advanced cancer. Specialized instruments, such as the QUAL-EC, may be useful to assess psychosocial issues associated with quality of life unique to this population.
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Objectives: To evaluate the measurement of the psychosocial dimensions of quality of life using the German translation of the QUAL-EC-Cancer-Psychosocial Questionnaire (QUALEC-P), including factor structure and psychometrics.
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Methods: 183 patients with advanced cancer from the University Medical Center HamburgEppendorf and University Medical Center Leipzig completed the QUAL-EC-P. We
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conducted exploratory factor analysis, and item and reliability analysis. We examined convergent validity with correlations between the scale and relevant psychological constructs.
Results: The sample was 60% female with mean age of 57.7 (SD=11.7). We extracted three factors accounting for 44% of the variance aligning with the structure of the instrument. The QUAL-EC-P showed good to acceptable internal consistency for the QoL-psychosocial total
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score (α=0.77), the Life Completion subscale (α=0.77) and the Relationship with Healthcare Provider subscale (α=0.81). The Preparation for End of Life subscale had adequate albeit low internal consistency (α=0.64) because concerns about family were less associated with financial worry and fear of death than expected. The psychosocial dimensions of QoL
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correlated negatively with depression (r=-0.27, p≤0.001), anxiety (r=-0.32, p≤0.001), demoralization (r=-0.63, p≤0.001), attachment insecurity (r=-0.51, p≤0.001) and positively
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with spiritual well-being (r=0.63, p≤0.001).
Conclusion: The QUAL-EC-P may be used to assess the psychosocial aspects of quality of life and promote their clinical discussion in patients with advanced cancer.
Keywords: cancer; advanced; quality of life; oncology; depression
Running title: Psychometric properties of the QUAL-EC-P
ACCEPTED MANUSCRIPT Introduction Advanced cancer patients suffer from multiple physical, psychosocial and spiritual problems [1–3] that affect quality of life (QoL) [4, 5]. Modern medicine has increasingly emphasized patient-oriented care including more holistic approaches and medical outcomes within the field of palliative and supportive care. This has led to greater interest in promoting well-being
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and adaptation to the end of life through early intervention and advance care planning [6, 7]. To maximize QoL, palliative and supportive care encourages preparation for death, a sense of life closure, and trust and reliance on health care teams to support patients and families at the
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end of life [8].
Although a consistent definition of QoL has proven to be elusive [9], four components have generally been distinguished: (1) illness-related physical complaints, (2) mental states that
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capture a patient’s emotional condition, (3) impairments caused by illness in everyday life, and (4) changes in social relationships as a function of these limitations [9, 10]. Improving any one of these aspects has a positive impact on QoL [11, 12, 13]. Studies have found that the assessment and discussion of QoL improves patient communication, symptom management and satisfaction with care [14, 15]. Such interactions may allow clinicians to
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explore patient values and beliefs to better inform medical decision-making [16].
To take QoL into consideration during clinical discussions, valid assessments of QoL are required. There are only a few validated questionnaires available today for use in advanced
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cancer [17, 18, 19]. The QUAL-E by Steinhauser and colleagues [8] is distinct from other tools in that it was constructed from the ground up based on patient interviews about QoL and quality of death [20]. The instrument comprises four dimensions: Symptom Control based on
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the discomfort associated with a self-nominated symptom identified as most severe; Relationship with Healthcare Provider which concerns the perceived supportiveness of the health care team in the context of progressive disease; Preparation for End of Life which addresses worries about the readiness of the patient and family to cope with death and dying; and Life Completion which concerns feelings of connection and of being known by a loved one. It is these latter three psychosocial factors that may lend the instrument a more holistic and patient-centred focus by addressing existential issues relevant to the end of life.
The 26-item QUAL-E has shown good psychometric properties (α=0.83 for Symptom Control, α=0.80 for Relationship with Healthcare Provider, α=0.73 for Preparation for End of Life and α=0.86 for Life Completion) [19]. In a clinical trial of early palliative care in patients
ACCEPTED MANUSCRIPT with advanced cancer, the intervention showed larger effects on the QUAL-E than on the more established FACT-G/FACIT-Sp [21, 22]. For brief assessment, it was validated into a 17-item short form called the QUAL-E-Cancer (QUAL-EC), which retained the factor structure of the original instrument but with fewer items [19].
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To promote the assessment and treatment of QoL in advanced cancer, we have translated the psychosocial subscales of the QUAL-EC into the German language. We focused on these three dimensions because we wanted an outcome that could show clinical benefit from psychotherapeutic intervention in a terminally ill population for whom physical deterioration
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is expected to worsen until death. The aim of the present study was to examine the factor structure and other psychometric properties of the German QUAL-EC-Psychosocial (QUALEC-P) questionnaire in a sample of advanced cancer patients. In regard to construct validity,
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we hypothesized significant negative associations between these psychosocial dimensions of quality of life and depression, anxiety, demoralization, and attachment insecurity (i.e. difficulty trusting and relying on others), and significant positive associations with spiritual well-being [4, 19, 25, 26, 27].
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Methods Participants and procedure
We recruited patients from the Outpatient Clinic for Psychooncology at the Department of Medical Psychology, University Medical Center Hamburg-Eppendorf; the Outpatient Cancer
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Counseling Center at the Department of Medical Psychology and Medical Sociology, University Medical Center Leipzig; and the universities’ cancer care units and external cancer
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care facilities. The sample analysed in this paper participated in the German CALM (Managing Cancer And Living Meaningfully) study, a randomized controlled trial of a psychotherapeutic intervention to improve distress and quality of life (see [24] for study protocol). Eligible patients were ≥18 years old and diagnosed with a solid, incurable advanced tumor (UICC stage III or IV). They suffered from clinically meaningful psychological distress (PHQ-9 ≥9 or Distress Thermometer ≥5), without necessarily having a current depressive episode. Exclusion criteria were severe cognitive or physical impairment, language barrier, current receipt of other psychosocial interventions and acute suicidality. After providing written informed consent, participants completed baseline self-reported measures, including the QUAL-EC-P. The study was approved by the local research ethics committees (Hamburg: PV4435; Leipzig: 143–14–14042014).
ACCEPTED MANUSCRIPT Measures The 14-item German QUAL-EC-Psychosocial (QUAL-EC-P) is composed of the three psychosocial subscales of the QUAL-E-Cancer (QUAL-EC) [19], which in turn is a short form of the QUAL-E [8]. These subscales are: Relationship with Healthcare Provider (5
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items), Preparation for End of Life (4 items) and Life Completion (5 items). Items are rated on a 5-point Likert-scale ranging from 1 (not at all) to 5 (completely), and has shown acceptable internal consistency (α=0.80, α=0.73, and α=0.83, respectively). Higher total and
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subscale scores indicate greater QoL.
Depression was assessed using the Depression Module of the Patient Health Questionnaire (PHQ-9) [28], which measures depression based on the symptom criteria of DSM-IV. Scores
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≥10 indicate moderate depression, scores ≥15 indicate severe depression. The German adaptation shows good internal consistency (α=0.89) [29, 30].
Anxiety was assessed using the Generalized Anxiety Disorder Questionnaire (GAD-7) [31, 32], which measures generalized anxiety disorder based on the symptom criteria of DSM-IV.
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Scores ≥10 indicate moderate anxiety, scores ≥15 indicate severe anxiety. The German adaptation shows good internal consistency (α=0.89).
Demoralization was assessed using the German version of the Demoralization Scale (DS) [33,
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34]. Scores ≥30 indicate high demoralization. The German adaption shows good internal consistency (α=0.84) [34, 35].
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Attachment insecurity was assessed using the Experiences in Close Relationships Scale (ECRM16) [36, 37] and refers to difficulty in trusting and relying on others in times of need. The scale measures dimensions of Attachment Anxiety (i.e. fear of abandonment) and Attachment Avoidance (i.e. defensive independence). An overall score may be calculated from the scale such that higher scores indicate greater insecurity. The German adaptation shows good internal consistency for the overall scale (α=0.83) [38].
Spiritual well-being was assessed using the Functional Assessment of Chronic Illness Therapy – Spiritual Well-Being Scale (FACIT-Sp) [22]. The scale measures the extent to which faith and spirituality contribute to the QoL of cancer patients. Higher scores indicate greater spiritual well-being. The scale has shown good internal consistency (α=0.80).
ACCEPTED MANUSCRIPT Statistical analysis Statistical analyses were performed using the Statistical Package for the Social Sciences (SPSS, 22.0). We conducted an exploratory factor analysis on the QUAL-EC-P using principal axis factoring (PAF) and varimax rotation. Factors were extracted based on their
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eigenvalues (≥1) and scree plot [39]. To identify significant loading items, we used as our criterion a factor loading >0.30 [40]. Item and reliability analysis were performed by calculating the mean, standard deviation, item difficulty and selectivity (discriminatory power), skewness and kurtosis, as well as Cronbach’s α and the mean inter-item correlation
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(MIC) as measures of internal consistency. To examine convergent validity we calculated Pearson correlations between theoretically related measures and the psychosocial total and subscale scores. The significance level of our two-sided tests was p≤0.05. Missing values
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occurred in 122 of 2,257 responses and were replaced with multiple imputation using the Markov chain Monte Carlo (MCMC) method. The imputation model included the variables gender, age, quality of life, death anxiety, depression, anxiety, demoralization, attachment insecurity, and spiritual well-being.
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Results
183 patients completed the QUAL-EC-P. See Table 1 for demographic and medical characteristics. Sixty-one percent reported moderate to severe depression (M=11.4; SD=5.2), 48% moderate to severe anxiety (M=9.7; SD=5.0), and 60% reported high demoralization
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(M=35.3; SD=15.9). The mean QoL-psychosocial total score was M=3.3 (SD=0.6), M=49.6 (SD=16.1) for the ECR-M16 and M=23.8 (SD=8.9) for the FACIT-Sp. The mean scores for the subscales of the QUAL-EC-P were M=3.4 (SD=0.9) for Relationship with Healthcare
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Provider, M=3.0 (SD=1.0) for Preparation for End of Life, and M=3.6 (SD=0.9) for Life Completion.
--------------------------------------Please insert Table 1 about here --------------------------------------Factor Structure The data were suitable for EFA according to the Kaiser-Meyer-Olkin measure of sampling adequacy value (MSA=0.74) and the Bartlett test of sphericity (χ²=778.82, df=91, p
