Clinical trial NCT01086683: Rehabilitation of Cancer Survivors in Denmark: The Effect of a Psychosocial Rehabilitation Course
Official title: Rehabilitation of Cancer Survivors in Denmark: A Randomized Controlled Trial on the Effect of a Multi-focused Psychosocial Rehabilitation Course
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Neoplasms
Breast Neoplasms
Colorectal Neoplasms
Prostatic Neoplasms
Keywords: neoplasms
rehabilitation
intervention
quality of life
lifestyle
Lead sponsor: Danish Cancer Society
Sponsor class: OTHER
Collaborators: name: University Hospital Århus, Department of Surgery
name: University Hospital Århus, Urology Department
name: Randers Regional Hospital
name: Regional Hospital Hørsholm, Department of Breast Surgery
First posted: 2010-03-15
Enrollment: 513
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: baseline, 1 month follow-up, 6 month follow-up, 12 month follow-up
Secondary outcomes:
measure: health behaviours: physical activity, diet, tobacco and alcohol consumption, use of health services
timeFrame: baseline, 1 month, 6 month, 12 month follow-up
measure: self-rated health
timeFrame: baseline, 1 month, 6 month, 12 month follow-up
measure: self-efficacy as measured with the General Self-Efficacy Scale (GSE)
timeFrame: baseline, 1 month, 6 month, 12 month follow-up
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Psychosocial Cancer Research
Study officials:
affiliation: Department of Psychosocial Cancer Research, Institute of Cancer Epidemiology and National Centre for Cancer Rehabilitation Research, University of Southern Denmark
name: Christoffer Johansen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.