A Phase 1 interventional study of Follow-up Telephone Genetic Counselling in BRCA1 Gene Mutation, BRCA2 Gene Mutation and Breast Cancer, sponsored by Women's College Hospital. Status unknown at 3 sites in Canada. Open to female participants aged 35 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-06-09.
Sponsored by Women's College Hospital · Phase 1, Interventional, and Supportive care
This study aims to develop a follow-up telephone-based genetic counselling (FTGC) intervention for women with a BRCA1 or BRCA2 mutation who have received genetic counseling in the past. Typically, when women undergo genetic testing, they receive standard genetic counselling prior to testing in order to fully understand the procedure and associated implications. If a woman's genetic test results are positive for a mutation, cancer prevention options are then discussed with a counsellor. However, in Canada, there is currently no formal follow-up counselling for women with a BRCA mutation to provide ongoing guidance and support about latest risk reduction strategies. Standard care relies on women making contact for any follow-up questions or concerns they may have. As a result, these women might not have the most current information regarding genetic risk assessment and prevention options. Therefore, individuals are being asked to participate in this study to aid research about the efficacy of FTGC in women with a BRCA mutation.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's planned enrollment of 300 is above the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
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Exclusion Criteria:
Individuals randomized to the intervention group will receive a tailored cancer risk assessment via a follow-up telephone genetic counselling (FTGC) session within one month of study enrollment.
Behavioral: Follow-up Telephone Genetic Counselling
Individuals randomized to the intervention group will receive a tailored cancer risk assessment at 12 months following study enrollment
Individualized theoretical genetic counselling among women with BRCA mutations to assess the impact it has on the uptake of cancer prevention strategies.
Efficacy of FTGC session
The primary aim is to determine the effects of a tailored risk communication intervention (FTGC) compared to a standard intervention
Time frame: 3 years
Emotional and cognitive outcomes of intervention
Secondary aims are to compare the two study groups with regard to intent of cancer prevention strategies, decisional conflict, cancer-related distress, cancer risk and prevention knowledge, choice predisposition and health service utilization.
Time frame: 3 yrs
This study is status unknown, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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