Feasibility of a Psychosocial Rehabilitation Intervention to Enhance the Involvement of Relatives in Cancer Rehabilitation: Pilot Study for a Randomized Controlled Trial
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Cancer often affects the quality of life and well-being of patients as well as their relatives. Previous studies have suggested that relatives should be involved in psychosocial rehabilitation to address the needs for an interpersonal relationship with others in the disease trajectory. We developed an innovative rehabilitation program to be offered to the patient and a relative as a pair.
The aim of the present pilot study was to examine the feasibility of the intervention in a randomized controlled trial (RCT) and to evaluate the impact on quality of life.
The study was designed as an RCT comparing the new multimodal psychosocial rehabilitation with the usual services. The intervention comprised three ‘supportive talks’ and a residential rehabilitation course. From March 2010 to March 2011, participation was offered at the time of diagnosis to patients with lung or gynecological cancer from two departments at Odense University Hospital in Denmark. Questionnaires were used to estimate changes in quality of life (EORTC-QLQ-C30 on global health status) and well-being (WHO-Five Well-Being Index) at baseline and after 2 and 12 months. Information on the participants’ views about the rehabilitation intervention was obtained from assessment charts and qualitative interviews.
A total of 209 patients were assessed for eligibility, but only 42 pairs were randomized to the study. The 2-month follow-up was completed by 34 patients and 32 relatives, and 19 patients and 21 relatives completed the 12-month follow-up. A higher dropout rate at the 12-month follow-up was reported in the intervention group compared with controls. Quality of life and well-being increased for patients and relatives in both the intervention and the control group, and no clinically significant difference was observed between the intervention and the control group. Pairs reported that the time of inclusion was inconvenient and that rehabilitation ought to meet their changing needs.
The pilot study showed that it may be difficult to conduct an RCT of a psychosocial rehabilitation intervention for pairs, and difficulties with inclusion and drop out have to be addressed. Interventions need to be carefully developed and tested before evaluating an effect in a large-scale study.
KeywordsGynecological Cancer Rehabilitation Service Rehabilitation Intervention Global Health Status Supportive Talk
The study was funded by the Danish Cancer Society (Grant number OKV 08008).
JK, OM, EJ, and HPH conceived the study and developed the design of the overall study. The study was conducted by LL in collaboration with OM, EJ, KLC, and HPH. RDC performed the statistical analyses in collaboration with LL. LL drafted the manuscript, and all authors were involved in critically revising it. All authors have read and approved the final manuscript.
We thank the patients and their relatives who participated in the study. We acknowledge the work of the project nurse, Biddy Madsen, and the important collaboration with nurses from Odense University Hospital, Gitte Bekker, Susanne Pedersen, and Camilla A. Holt, and also the staff at Rehabilitation Center Dallund. The Danish Milieu for Humanistic Cancer Research (http://www.mifohuk.dk) provided support for discussions and writing seminars.
Conflicts of interests
The authors declare no conflict of interest, and the authors alone are responsible for the content of the paper.
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