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

NCT ID: NCT01086683

Last Updated: 2010-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

513 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2009-12-31

Brief Summary

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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

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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.

Conditions

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Neoplasms Breast Neoplasms Colorectal Neoplasms Prostatic Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention group

Group Type EXPERIMENTAL

Psychosocial rehabilitation course

Intervention Type 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.

Control group

Wait list control group: The control group received usual care including clinical control visits but no systematic rehabilitation activities.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Århus, Department of Surgery

UNKNOWN

Sponsor Role collaborator

University Hospital Århus, Urology Department

UNKNOWN

Sponsor Role collaborator

Randers Regional Hospital

OTHER

Sponsor Role collaborator

Regional Hospital Hørsholm, Department of Breast Surgery

UNKNOWN

Sponsor Role collaborator

Danish Cancer Society

OTHER

Sponsor Role lead

Responsible Party

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Department of Psychosocial Cancer Research, Institute of Cancer Epidemiology, The Danish Cancer Society

Principal Investigators

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Christoffer Johansen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Department of Psychosocial Cancer Research

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 21231790 (View on PubMed)

Other Identifiers

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225 06 001

Identifier Type: -

Identifier Source: org_study_id

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