Rehabilitation of Cancer Survivors in Denmark: The Effect of a Psychosocial Rehabilitation Course
Primary Purpose
Neoplasms, Breast Neoplasms, Colorectal Neoplasms
Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Psychosocial rehabilitation course
Sponsored by
About this trial
This is an interventional supportive care trial for Neoplasms focused on measuring neoplasms, rehabilitation, intervention, quality of life, lifestyle
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
Sites / Locations
- Department of Psychosocial Cancer Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
Wait list control group: The control group received usual care including clinical control visits but no systematic rehabilitation activities.
Outcomes
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)
self-report questionnaire
Secondary Outcome Measures
health behaviours: physical activity, diet, tobacco and alcohol consumption, use of health services
self-report questionnaire
self-rated health
self-report item
self-efficacy as measured with the General Self-Efficacy Scale (GSE)
self-report questionnaire
Full Information
NCT ID
NCT01086683
First Posted
March 12, 2010
Last Updated
March 12, 2010
Sponsor
Danish Cancer Society
Collaborators
University Hospital Århus, Department of Surgery, University Hospital Århus, Urology Department, Randers Regional Hospital, Regional Hospital Hørsholm, Department of Breast Surgery
1. Study Identification
Unique Protocol Identification Number
NCT01086683
Brief Title
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
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Danish Cancer Society
Collaborators
University Hospital Århus, Department of Surgery, University Hospital Århus, Urology Department, Randers Regional Hospital, Regional Hospital Hørsholm, Department of Breast Surgery
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Prostatic Neoplasms
Keywords
neoplasms, rehabilitation, intervention, quality of life, lifestyle
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
513 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Wait list control group: The control group received usual care including clinical control visits but no systematic rehabilitation activities.
Intervention Type
Behavioral
Intervention Name(s)
Psychosocial rehabilitation course
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Description
self-report questionnaire
Time Frame
baseline, 1 month follow-up, 6 month follow-up, 12 month follow-up
Secondary Outcome Measure Information:
Title
health behaviours: physical activity, diet, tobacco and alcohol consumption, use of health services
Description
self-report questionnaire
Time Frame
baseline, 1 month, 6 month, 12 month follow-up
Title
self-rated health
Description
self-report item
Time Frame
baseline, 1 month, 6 month, 12 month follow-up
Title
self-efficacy as measured with the General Self-Efficacy Scale (GSE)
Description
self-report questionnaire
Time Frame
baseline, 1 month, 6 month, 12 month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoffer Johansen, MD, PhD
Organizational Affiliation
Department of Psychosocial Cancer Research, Institute of Cancer Epidemiology and National Centre for Cancer Rehabilitation Research, University of Southern Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychosocial Cancer Research
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
21231790
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.
Results Reference
derived
Learn more about this trial
Rehabilitation of Cancer Survivors in Denmark: The Effect of a Psychosocial Rehabilitation Course
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