RCT of a Group Intervention for Women With a Family History of Breast Cancer
A Randomized Controlled Trial of a Group Intervention for Women With a Family History of Breast Cancer
2 other identifiers
interventional
150
1 country
1
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 developing BC. Elevated risk perceptions for BC have been associated with psychological distress, which, in turn, can interfere with screening adherence. In our completed CBCRI-funded study, we developed and standardized a group intervention designed to address the psychological issues associated with having a family history of BC. Results demonstrated that the intervention led to significant improvement in levels of anxiety and depression, improved BC risk factors/genetics knowledge and was associated with optimal screening behavior. The proposed study will rigorously test the group intervention in comparison to standard risk counselling in a sample of 150 women recruited from Familial BC clinics in Toronto. The interventions will be examined for their impact on a) psychological functioning, b) BC risk/genetic knowledge and c) screening behaviors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2001
Longer than P75 for phase_3
1 active site
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
July 1, 2001
CompletedFirst Submitted
Initial submission to the registry
September 6, 2005
CompletedFirst Posted
Study publicly available on registry
September 8, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedJune 17, 2008
December 1, 2006
5.4 years
September 6, 2005
June 12, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Psychosocial functioning (using standardized instruments)
1 year
Breast Cancer risk/genetic knowledge
1 year
Screening behaviors
1 year
Secondary Outcomes (2)
Post Traumatic Growth
1 year
Cost effectiveness
1 year
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Health Network, Torontolead
- Canadian Breast Cancer Research Alliancecollaborator
- Canadian Cancer Trials Groupcollaborator
Study Sites (1)
University Health Network
Toronto, Ontario, M5G 2C4, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mary Jane Esplen, PhD
University Health Network, Toronto
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 6, 2005
First Posted
September 8, 2005
Study Start
July 1, 2001
Primary Completion
December 1, 2006
Study Completion
January 1, 2007
Last Updated
June 17, 2008
Record last verified: 2006-12