Internet-based Support in Cancer Rehabilitation

This study has been completed.
Sponsor:
Collaborators:
TrygFonden, Denmark
IMK Almene Fond
Information provided by:
Danish Cancer Society
ClinicalTrials.gov Identifier:
NCT00961610
First received: August 17, 2009
Last updated: August 18, 2009
Last verified: August 2009
  Purpose

This 2-arm randomized trial assessed the incremental effect of providing a lecture on Internet use followed by participation in an Internet-based peer support group following a week-long rehabilitation program, over and above any possible general effect of participation in the rehabilitation program.

Primary outcome measures are adjustment to cancer and mood disturbance.


Condition Intervention
Cancer
Behavioral: Internet peer-support group

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Internet-based Support in the Rehabilitation of Danish Cancer Survivors

Resource links provided by NLM:


Further study details as provided by Danish Cancer Society:

Primary Outcome Measures:
  • Adjustment to cancer measured by the Mini-MAC scale Mood disturbance measured by POMS-SF scale [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self-rated global health [ Designated as safety issue: No ]

Enrollment: 794
Study Start Date: April 2004
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Internet support group Intervention Behavioral: Internet peer-support group

The Internet peer-support groups provided a self-guided space for communication, including an Internet discussion forum, a live chat room and a personal message system. No therapeutic content or information services were offered within the groups.

All Internet groups were run in a browser-based software platform with access through the website of the Danish Cancer Society (http://www.cancer.dk). All discussions were protected by a password and communication was encrypted.

The Internet groups in this study were all closed peer-support groups, accessible only by an invitation received by e-mail after registration for the study. The groups were open to access 24 h a day for 13 months from their individual starting date.

Control group Behavioral: Internet peer-support group

The Internet peer-support groups provided a self-guided space for communication, including an Internet discussion forum, a live chat room and a personal message system. No therapeutic content or information services were offered within the groups.

All Internet groups were run in a browser-based software platform with access through the website of the Danish Cancer Society (http://www.cancer.dk). All discussions were protected by a password and communication was encrypted.

The Internet groups in this study were all closed peer-support groups, accessible only by an invitation received by e-mail after registration for the study. The groups were open to access 24 h a day for 13 months from their individual starting date.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Sampling Method:   Probability Sample
Study Population

A total of 66 scheduled rehabilitation course weeks were screened for eligibility between 19 April 2004 and 31 December 2005 from the Rehabilitation Centre Dallund in Denmark. All 58 eligible courses including 921 individuals were enrolled and randomized as 27 case weeks (n = 416 persons) and 31 control weeks (n = 505 persons). Baseline assessments were obtained from 799 individuals. Data from 10 individuals (5 from each treatment group) were subsequently excluded, as they did not attend a rehabilitation course week as planned, leaving final study population of 794 individuals analyzed by 'intention-to-treat' (case: n = 361/794; control: n = 433/794). Participants were followed up for 12 months in accordance with their dates of attendance of the rehabilitation course from 19 April 2004 till 31 December 2006.

Criteria

Inclusion Criteria:

  • Cancer survivors who were randomized for or self-selected to a rehabilitation course at the Dallund Rehabilitation Centre were included in the study.

Exclusion Criteria:

  • Rehabilitation course weeks in which cancer survivors over 50 years of age were targeted specifically were excluded.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00961610

Locations
Denmark
Department of Psychsocial Cancer Research
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Danish Cancer Society
TrygFonden, Denmark
IMK Almene Fond
Investigators
Principal Investigator: Christoffer Johansen, MD, PhD, DrMedSci Department of Psychosocial Cancer Research
  More Information

No publications provided

Responsible Party: Christoffer Johansen, Department of Psychosocial Cancer Research
ClinicalTrials.gov Identifier: NCT00961610     History of Changes
Other Study ID Numbers: PP-07024
Study First Received: August 17, 2009
Last Updated: August 18, 2009
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Danish Cancer Society:
internet support
cancer
rehabilitation

ClinicalTrials.gov processed this record on April 22, 2014