Status:
COMPLETED
RCT of a Group Intervention for Women With a Family History of Breast Cancer
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Canadian Breast Cancer Research Alliance
Canadian Cancer Trials Group
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
18-70 years
Phase:
PHASE3
Brief Summary
One in 10 Canadian women will be diagnosed with breast cancer (BC) and approximately 5% of all BC is believed to be hereditary. Women with a family history experience high levels of perceived risk for...
Detailed Description
Keywords: Breast cancer, genetics, psychotherapy, group counselling, randomized control trial, risk counselling, women's mental health, familial breast cancer. One in 10 Canadian women will be diagno...
Eligibility Criteria
Inclusion
- at least one 1st-degree relative with Breast Cancer
- age 18-70 years
- live within one hour of downtown Toronto
- score higher than 15 in Breast Cancer Anxiety Scale (BCAS)
Exclusion
- Carrier status for genetic mutation (i.e. BRCA1) known
- Previous diagnosis of breast cancer or other malignancy (other than non-melanoma skin cancer)
- History of major psychiatric disorder, such as schizophrenia, active psychosis, untreated major depression, as defined in the DSM IV and obtained through a semi-structured psychiatric interview
- Failure to provide informed consent
Key Trial Info
Start Date :
July 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00150917
Start Date
July 1 2001
End Date
January 1 2007
Last Update
June 17 2008
Active Locations (1)
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1
University Health Network
Toronto, Ontario, Canada, M5G 2C4