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


Phase 2/Phase 3
18 Years
N/A
Not Enrolling
Both
Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Prostatic Neoplasms

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

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)

Outcome Description:

self-report questionnaire

Outcome Time Frame:

baseline, 1 month follow-up, 6 month follow-up, 12 month follow-up

Safety Issue:

No

Principal Investigator

Christoffer Johansen, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Psychosocial Cancer Research, Institute of Cancer Epidemiology and National Centre for Cancer Rehabilitation Research, University of Southern Denmark

Authority:

Denmark: Danish Data Protection Agency (Datatilsynet)

Study ID:

225 06 001

NCT ID:

NCT01086683

Start Date:

May 2004

Completion Date:

December 2009

Related Keywords:

  • Neoplasms
  • Breast Neoplasms
  • Colorectal Neoplasms
  • Prostatic Neoplasms
  • neoplasms
  • rehabilitation
  • intervention
  • quality of life
  • lifestyle
  • Breast Neoplasms
  • Neoplasms
  • Colorectal Neoplasms
  • Prostatic Neoplasms

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