RCT of a Group Intervention for Women With a Family History of Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00150917|
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : June 17, 2008
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasms||Behavioral: Supportive-Expressive Group Therapy||Phase 3|
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 diagnosed with breast cancer (BC) and approximately 5% of all BC is believed to be hereditary. Women with a family history of BC experience high levels of perceived risk and vulnerability for developing BC. Elevated risk perceptions for BC are difficult to modify and have been associated with psychological distress that, in turn, can interfere with screening adherence. The specific objectives of the current randomized trial are to determine the effects of a supportive-expressive group intervention on a) psychosocial functioning (using standardized instruments), b) BC risk/genetic knowledge and c) screening behaviors in women with a family history of breast cancer receiving standard genetic risk counseling. Preliminary data will be collected to examine the cost effectiveness of the intervention.
The study is being conducted in the following University of Toronto affiliated teaching hospitals: Mount Sinai Hospital; Preventive Oncology Program, Sunnybrook and Women's College Health Sciences; Toronto Sunnybrook Regional Cancer Centre; University Health Network; North York General Hospital; Credit Valley Hospital. A total of 150 women with a family history of BC will be randomized in a ratio of 2 to 1 to participate in an 8 weekly/ 4 monthly support group or to a control arm that receives educational materials.
The study has been funded by the Canadian Breast Cancer Research Initiative (CBCRI) of the National Cancer Institute of Canada since 2001. To date 66 women have been enrolled in the study and we anticipate a total of 90 women will be enrolled by the end of the current funding year in June 2004. At this rate it is expected that recruitment will be completed in June 2005, the last intervention groups will be completed by January 2006 and that analysis of the final study results will be completed by June 2006. Analysis of baseline data will begin in September 2005 once the last study groups have been initiated and a manuscript reporting the final results will be prepared by June 2006. Two years of funding is requested for these activities.
Significance: Technological advances in molecular biology and genetics are occurring rapidly. Our proposed research has direct relevance for advancing knowledge on the communication and provision of risk/genetic information to individuals with a family history of BC and has both direct and indirect relevance to individuals at all stages of cancer. Improved counselling techniques for those with a family history may impact on the prevention and management of BC through improved surveillance and preventive techniques, enhanced psychosocial functioning and wellbeing through increased psychological resilience. In addition, effective risk counselling interventions may facilitate the understanding of and decision-making around genetic testing, and the adjustment to a cancer diagnosis, should these women with family histories later develop the disease.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Trial of a Group Intervention for Women With a Family History of Breast Cancer|
|Study Start Date :||July 2001|
|Primary Completion Date :||December 2006|
|Study Completion Date :||January 2007|
- Psychosocial functioning (using standardized instruments) [ Time Frame: 1 year ]
- Breast Cancer risk/genetic knowledge [ Time Frame: 1 year ]
- Screening behaviors [ Time Frame: 1 year ]
- Post Traumatic Growth [ Time Frame: 1 year ]
- Cost effectiveness [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00150917
|University Health Network|
|Toronto, Ontario, Canada, M5G 2C4|
|Principal Investigator:||Mary Jane Esplen, PhD||University Health Network, Toronto|