Breast Cancer Clinical Trial
— CBCRA09Official title:
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.
Status | Not yet recruiting |
Enrollment | 210 |
Est. completion date | March 2015 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - less than 46 years old with primary breast cancer Exclusion Criteria: - older than 45 and in active treatment |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
British Columbia Cancer Agency | CancerCare Manitoba, McMaster University, Tom Baker Cancer Centre, University of British Columbia, University of Calgary |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
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