Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00150917
Status:
COMPLETED
Last Update Posted:
2008-06-17
First Post:
2005-09-06
Brief Title:
RCT of a Group Intervention for Women With a Family History of Breast Cancer
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
A Randomized Controlled Trial of a Group Intervention for Women With a Family History of Breast Cancer
Status:
COMPLETED
Status Verified Date:
2006-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 factorsgenetics 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 riskgenetic knowledge and c screening behaviors
Detailed Description:
Keywords Breast cancer genetics psychotherapy group counselling randomized control trial risk counselling womens 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 riskgenetic 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 Womens 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 riskgenetic 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
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 riskgenetic 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 Womens 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 riskgenetic 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CBCRA 015445 | None | None | None |