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Completed

NCT Number: NCT01086683

Rehabilitation of Cancer Survivors in Denmark: The Effect of a 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.

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Key information

Conditions

Neoplasms Breast Diseases Breast Neoplasms Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Intestinal Diseases Intestinal Neoplasms Male Urogenital Diseases Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Rectal Diseases Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of Psychosocial Cancer Research

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychosocial rehabilitation course

Behavioral

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 outcomes

  1. 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

    self-report questionnaire

Secondary outcomes

  1. health behaviours: physical activity, diet, tobacco and alcohol consumption, use of health services

    Time frame: baseline, 1 month, 6 month, 12 month follow-up

    self-report questionnaire

  2. self-rated health

    Time frame: baseline, 1 month, 6 month, 12 month follow-up

    self-report item

  3. self-efficacy as measured with the General Self-Efficacy Scale (GSE)

    Time frame: baseline, 1 month, 6 month, 12 month follow-up

    self-report questionnaire

Sponsors and collaborators

Lead sponsor

Danish Cancer Society

Other

Collaborators

  • Randers Regional Hospital
  • Regional Hospital Hørsholm, Department of Breast Surgery
  • University Hospital Århus, Department of Surgery
  • University Hospital Århus, Urology Department

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2008
Study completion
2009
First posted
Mar 15, 2010
Registry last updated
Mar 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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