NCT00961610

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
794

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2004

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 19, 2009

Completed
Last Updated

August 19, 2009

Status Verified

August 1, 2009

Enrollment Period

2.7 years

First QC Date

August 17, 2009

Last Update Submit

August 18, 2009

Conditions

Keywords

internet supportcancerrehabilitation

Outcome Measures

Primary Outcomes (1)

  • Adjustment to cancer measured by the Mini-MAC scale Mood disturbance measured by POMS-SF scale

Secondary Outcomes (1)

  • Self-rated global health

Study Arms (2)

Internet support group Intervention

Behavioral: Internet peer-support group

Control group

Behavioral: Internet peer-support group

Interventions

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 groupInternet support group Intervention

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • Rehabilitation course weeks in which cancer survivors over 50 years of age were targeted specifically were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychsocial Cancer Research

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Christoffer Johansen, MD, PhD, DrMedSci

    Department of Psychosocial Cancer Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 17, 2009

First Posted

August 19, 2009

Study Start

April 1, 2004

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

August 19, 2009

Record last verified: 2009-08

Locations