- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01089699
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Kate MacGregor, MPH
- Phone Number: 4955 604-707-5900
Study Contact Backup
- Name: Joanne Stephen, Ph.D.
- Phone Number: 4960 604-707-5900
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- less than 46 years old with primary breast cancer
Exclusion Criteria:
- older than 45 and in active treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Professionally-led online support
Members assigned to 10-week online support group with a professional counsellor.
|
online support group
Other Names:
|
ACTIVE_COMPARATOR: Peer-led online support
|
online support group
Other Names:
|
ACTIVE_COMPARATOR: self-study materials
|
self-study materials
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduced anxiety
Time Frame: 1 year
|
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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H09-03302
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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