A Trial Testing Professional and Peer-led Support Online Support Groups for Young Canadian Breast Cancer Survivors
CBCRA09
A Randomized Control Trial Testing the Efficacy of Professional and Peer-Led Online Support Groups for Young Canadian Breast Cancer Survivors
1 other identifier
interventional
210
0 countries
N/A
Brief Summary
Young women who have finished treatment for breast cancer regularly report a lack of psychological and social support in their lives. They often continue to struggle with survivorship issues such as ongoing distress and the challenge of how to rebuild their lives after treatment. This experiment will compare two online support group (OSG) options to determine if both forms of support help young breast cancer survivors adjust, by reducing treatment-related intrusions and helping women re-engage in valued activities and commitments. It will also test if these 2 types of OSG's help womens' mood, feelings of loneliness, confidence, and overall life satisfaction. It will explore the processes within support groups that help to create positive change for young women after cancer treatment. Previous work by this team in a smaller study has shown that online support groups led by professional counselors can be carried out over the Internet, and that they produce helpful benefits for young women survivors of breast cancer. The online groups were comprised of 10 sessions of real time chats, with each session focused on a specific topic. Participants were provided with an educational manual designed to improve skills for coping after cancer, and they were instructed to read one chapter a week in preparation for the chats. The women enjoyed the groups and 3 months after completing the groups, they reported improved quality of life, lower emotional distress, and enhanced coping. However, a large study to determine the strength and reliability of these early promising findings is needed. The questions to be examined are whether trained peers (other young breast cancer survivors) might be able to facilitate the online groups and provide similar positive benefits for young breast cancer survivors, and what facilitators can do to maximize positive benefits in online support groups. This is a multi-provincial, 3-arm study that will compare a professionally-led OSG (with an educational manual) and a peer-led OSG (with an education manual) with a group that just receives the educational manual. Psychological assessment measures given immediately following the 12 week group, and at 6 months and 12 months follow-up, will determine if one or both of the study groups effectively improve quality of life, reduce distress, and enhance self-efficacy and life satisfaction for young breast cancer survivors. Additionally, tests will be performed to investigate whether discussing emotional matters predicts greater improvements.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1 breast-cancer
Started Apr 2010
Longer than P75 for early_phase_1 breast-cancer
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
First Submitted
Initial submission to the registry
March 17, 2010
CompletedFirst Posted
Study publicly available on registry
March 18, 2010
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedMarch 18, 2010
November 1, 2009
2.9 years
March 17, 2010
March 17, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduced anxiety
Psychological assessment measures given immediately following the 12 week group, and at 6 months and 12 months follow-up, will determine if one or both of the study groups effectively improve quality of life, reduce distress, and enhance self-efficacy and life satisfaction for young breast cancer survivors. Additionally, tests will be performed to investigate whether discussing emotional matters predicts greater improvements.
1 year
Study Arms (3)
Professionally-led online support
ACTIVE COMPARATORMembers assigned to 10-week online support group with a professional counsellor.
Peer-led online support
ACTIVE COMPARATORself-study materials
ACTIVE COMPARATORInterventions
online support group
self-study materials
Eligibility Criteria
You may qualify if:
- less than 46 years old with primary breast cancer
You may not qualify if:
- older than 45 and in active treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- British Columbia Cancer Agencylead
- University of Calgarycollaborator
- McMaster Universitycollaborator
- University of British Columbiacollaborator
- Tom Baker Cancer Centrecollaborator
- CancerCare Manitobacollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 17, 2010
First Posted
March 18, 2010
Study Start
April 1, 2010
Primary Completion
March 1, 2013
Study Completion
March 1, 2015
Last Updated
March 18, 2010
Record last verified: 2009-11