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

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01086683
• Other study ID #: 225 06 001
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 12, 2010
• Last updated: March 12, 2010
• Start date: May 2004
• Est. completion date: December 2009

Study information

• Verified date: March 2010
• Source: Danish Cancer Society
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Data Protection Agency (Datatilsynet)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 513
• Est. completion date: December 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Neoplasms
• Colorectal Neoplasms
• Neoplasms
• Prostatic Neoplasms

Intervention

Behavioral:
• Psychosocial rehabilitation course
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.

Locations

Country	Name	City	State
Denmark	Department of Psychosocial Cancer Research	Copenhagen

Sponsors (5)

Lead Sponsor	Collaborator
Danish Cancer Society	Randers Regional Hospital, Regional Hospital Hørsholm, Department of Breast Surgery, University Hospital Århus, Department of Surgery, University Hospital Århus, Urology Department

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	self-rated health	self-report item	baseline, 1 month, 6 month, 12 month follow-up	No
Secondary	self-efficacy as measured with the General Self-Efficacy Scale (GSE)	self-report questionnaire	baseline, 1 month, 6 month, 12 month follow-up	No