Rehabilitation of Cancer Survivors in Denmark: The Effect of a Psychosocial Rehabilitation Course
1 other identifier
interventional
513
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2004
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 12, 2010
CompletedFirst Posted
Study publicly available on registry
March 15, 2010
CompletedMarch 15, 2010
March 1, 2010
4.6 years
March 12, 2010
March 12, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
health behaviours: physical activity, diet, tobacco and alcohol consumption, use of health services
baseline, 1 month, 6 month, 12 month follow-up
self-rated health
baseline, 1 month, 6 month, 12 month follow-up
self-efficacy as measured with the General Self-Efficacy Scale (GSE)
baseline, 1 month, 6 month, 12 month follow-up
Study Arms (2)
Intervention group
EXPERIMENTALControl group
NO INTERVENTIONWait list control group: The control group received usual care including clinical control visits but no systematic rehabilitation activities.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Diagnosis of breast, colorectal or prostate cancer
- Completion of primary treatment
- Ability to participate physically in the activities offered in the intervention
You may not qualify if:
- Acute need for treatment
- Terminal cancer phase
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Danish Cancer Societylead
- University Hospital Århus, Department of Surgerycollaborator
- University Hospital Århus, Urology Departmentcollaborator
- Randers Regional Hospitalcollaborator
- Regional Hospital Hørsholm, Department of Breast Surgerycollaborator
Study Sites (1)
Department of Psychosocial Cancer Research
Copenhagen, 2100, Denmark
Related Publications (1)
Ibfelt E, Rottmann N, Kjaer T, Hoybye MT, Ross L, Frederiksen K, Johansen C, Dalton SO. No change in health behavior, BMI or self-rated health after a psychosocial cancer rehabilitation: Results of a randomized trial. Acta Oncol. 2011 Feb;50(2):289-98. doi: 10.3109/0284186X.2010.531761.
PMID: 21231790DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christoffer Johansen, MD, PhD
Department of Psychosocial Cancer Research, Institute of Cancer Epidemiology and National Centre for Cancer Rehabilitation Research, University of Southern Denmark
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 12, 2010
First Posted
March 15, 2010
Study Start
May 1, 2004
Primary Completion
December 1, 2008
Study Completion
December 1, 2009
Last Updated
March 15, 2010
Record last verified: 2010-03