Rehabilitation of Cancer Survivors in Denmark: The Effect of a Psychosocial Rehabilitation Course

Study Overview
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Brief Summary
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This randomized study evaluates the effect of a multi-focused, psychosocial 6-day residential rehabilitation course at a Danish rehabilitation centre for cancer survivors. The investigators hypothesize that individuals in the intervention group will experience better psychosocial well-being and more adaptive health behaviour changes as compared to individuals in the control group.

Detailed Description
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Worldwide, the number of cancer survivors is increasing. In the Danish population of 5.4 million people, more than 300 000 are cancer survivors. Given the range of physical, psychological and social late effects of cancer and its primary treatment many survivors need tailored rehabilitation interventions. This randomized study evaluates the effect of a multi-focused, psychosocial 6-day residential rehabilitation course at the Dallund Rehabilitation Centre in Denmark. We hypothesize that individuals in the intervention group will experience better psychosocial well-being and more adaptive health behaviour changes as compared to individuals in the control group.

Official Title
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Rehabilitation of Cancer Survivors in Denmark: A Randomized Controlled Trial on the Effect of a Multi-focused Psychosocial Rehabilitation Course

Conditions
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Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Prostatic Neoplasms

Intervention / Treatment
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* Behavioral: Psychosocial rehabilitation course


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of breast, colorectal or prostate cancer Completion of primary treatment Ability to participate physically in the activities offered in the intervention Exclusion Criteria: Acute need for treatment Terminal cancer phase

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br> | Behavioral: Psychosocial rehabilitation course<br>* Groups of 20 cancer survivors participated in a 6-day multi-focused, psychosocial intervention at the Dallund rehabilitation centre. The overall aim was to strengthen each individual's physical, psychological and social functioning. Sharing experiences with other cancer patients and experiencing peer-support was a central issue. The retreat combined lectures, discussions and patient group work on themes such as the treatment of cancer, psychological reactions, spirituality, sexuality and lifestyle. Participants were involved in physical activities, and the daily menu represented a healthy diet. The course was conducted by a multi-disciplinary team. Each participant produced a personal, specific 'action plan', which was intended to serve as a 'booster' after returning to daily life.<br>|
| No Intervention: Control group<br>Wait list control group: The control group received usual care including clinical control visits but no systematic rehabilitation activities. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| psychosocial well-being (as assessed by the EORTC-QLQ C30 Quality of life core questionnaire by the European Organization of Research and Treatment in Cancer (EORTC-QLQ C30) and the Profile of Mood States Short form (POMS-SF) | self-report questionnaire | baseline, 1 month follow-up, 6 month follow-up, 12 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| health behaviours: physical activity, diet, tobacco and alcohol consumption, use of health services | self-report questionnaire | baseline, 1 month, 6 month, 12 month follow-up | 
| self-rated health | self-report item | baseline, 1 month, 6 month, 12 month follow-up | 
| self-efficacy as measured with the General Self-Efficacy Scale (GSE) | self-report questionnaire | baseline, 1 month, 6 month, 12 month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neoplasms, rehabilitation, intervention, quality of life, lifestyle