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

This study has been completed.
Sponsor:
Collaborators:
University Hospital Århus, Department of Surgery
University Hospital Århus, Urology Department
Regional Hospital Randers, Department of Colorectal Surgery
Regional Hospital Hørsholm, Department of Breast Surgery
Information provided by:
Danish Cancer Society
ClinicalTrials.gov Identifier:
NCT01086683
First received: March 12, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted

March 12, 2010
March 12, 2010
May 2004
December 2008   (final data collection date for primary outcome 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) [ Time Frame: baseline, 1 month follow-up, 6 month follow-up, 12 month follow-up ] [ Designated as safety issue: No ]
self-report questionnaire
Same as current
No Changes Posted
  • health behaviours: physical activity, diet, tobacco and alcohol consumption, use of health services [ Time Frame: baseline, 1 month, 6 month, 12 month follow-up ] [ Designated as safety issue: No ]
    self-report questionnaire
  • self-rated health [ Time Frame: baseline, 1 month, 6 month, 12 month follow-up ] [ Designated as safety issue: No ]
    self-report item
  • self-efficacy as measured with the General Self-Efficacy Scale (GSE) [ Time Frame: baseline, 1 month, 6 month, 12 month follow-up ] [ Designated as safety issue: No ]
    self-report questionnaire
Same as current
Not Provided
Not Provided
 
Rehabilitation of Cancer Survivors in Denmark: The Effect of a Psychosocial Rehabilitation Course
Rehabilitation of Cancer Survivors in Denmark: A Randomized Controlled Trial on the Effect of a Multi-focused Psychosocial Rehabilitation Course

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.

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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Neoplasms
  • Breast Neoplasms
  • Colorectal Neoplasms
  • Prostatic Neoplasms
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.
  • Experimental: Intervention group
    Intervention: Behavioral: Psychosocial rehabilitation course
  • No Intervention: Control group
    Wait list control group: The control group received usual care including clinical control visits but no systematic rehabilitation activities.
Ibfelt E, Rottmann N, Kjaer T, Høybye 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
513
December 2009
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01086683
225 06 001
No
Professor Christoffer Johansen, MD, PhD, DMSc, Department of Psychosocial Cancer Research, Institute of Cancer Epidemiology, The Danish Cancer Society
Danish Cancer Society
  • University Hospital Århus, Department of Surgery
  • University Hospital Århus, Urology Department
  • Regional Hospital Randers, Department of Colorectal Surgery
  • Regional Hospital Hørsholm, Department of Breast Surgery
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
Danish Cancer Society
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP