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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
  Purpose

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.


Condition Intervention Phase
Neoplasms
Breast Neoplasms
Colorectal Neoplasms
Prostatic Neoplasms
Behavioral: Psychosocial rehabilitation course
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Rehabilitation of Cancer Survivors in Denmark: A Randomized Controlled Trial on the Effect of a Multi-focused Psychosocial Rehabilitation Course

Resource links provided by NLM:


Further study details as provided by Danish Cancer Society:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 513
Study Start Date: May 2004
Study Completion Date: December 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention group 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.
No Intervention: Control group
Wait list control group: The control group received usual care including clinical control visits but no systematic rehabilitation activities.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01086683

Locations
Denmark
Department of Psychosocial Cancer Research
Copenhagen, Denmark, 2100
Sponsors and Collaborators
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
Investigators
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
  More Information

No publications provided by Danish Cancer Society

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professor Christoffer Johansen, MD, PhD, DMSc, Department of Psychosocial Cancer Research, Institute of Cancer Epidemiology, The Danish Cancer Society
ClinicalTrials.gov Identifier: NCT01086683     History of Changes
Other Study ID Numbers: 225 06 001
Study First Received: March 12, 2010
Last Updated: March 12, 2010
Health Authority: Denmark: Danish Data Protection Agency (Datatilsynet)

Keywords provided by Danish Cancer Society:
neoplasms
rehabilitation
intervention
quality of life
lifestyle

Additional relevant MeSH terms:
Breast Neoplasms
Colorectal Neoplasms
Neoplasms
Prostatic Neoplasms
Breast Diseases
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site
Prostatic Diseases
Rectal Diseases
Skin Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014