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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| London Health Sciences Centre | OTHER |
| Princess Margaret Hospital, Canada | OTHER |
| H. Lee Moffitt Cancer Center and Research Institute |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FTGC at 1 month | Active Comparator | 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. |
|
| Standard Care + FTGC in 12 months | No Intervention | Individuals randomized to the intervention group will receive a tailored cancer risk assessment at 12 months following study enrollment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Follow-up Telephone Genetic Counselling | Behavioral | Individualized theoretical genetic counselling among women with BRCA mutations to assess the impact it has on the uptake of cancer prevention strategies. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of FTGC session | The primary aim is to determine the effects of a tailored risk communication intervention (FTGC) compared to a standard intervention | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 yrs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sophia Virani | Contact | 416-351-3800 | 2761 | sophia.virani@wchospital.ca |
| Name | Affiliation | Role |
|---|---|---|
| Kelly Metcalfe, Dr. | University of Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Regional Cancer Centre | Not yet recruiting | London | Ontario | N6C 2R6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24449229 | Background | Kinney AY, Boonyasiriwat W, Walters ST, Pappas LM, Stroup AM, Schwartz MD, Edwards SL, Rogers A, Kohlmann WK, Boucher KM, Vernon SW, Simmons RG, Lowery JT, Flores K, Wiggins CL, Hill DA, Burt RW, Williams MS, Higginbotham JC. Telehealth personalized cancer risk communication to motivate colonoscopy in relatives of patients with colorectal cancer: the family CARE Randomized controlled trial. J Clin Oncol. 2014 Mar 1;32(7):654-62. doi: 10.1200/JCO.2013.51.6765. Epub 2014 Jan 21. | |
| 18268356 |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010051 | Ovarian Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| OTHER |
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| Women's College Hospital | Recruiting | Toronto | Ontario | M5S 1B1 | Canada |
|
| Princess Margaret Hospital | Not yet recruiting | Toronto | Ontario | M5T 2M9 | Canada |
|
| Background |
| Kauff ND, Domchek SM, Friebel TM, Robson ME, Lee J, Garber JE, Isaacs C, Evans DG, Lynch H, Eeles RA, Neuhausen SL, Daly MB, Matloff E, Blum JL, Sabbatini P, Barakat RR, Hudis C, Norton L, Offit K, Rebbeck TR. Risk-reducing salpingo-oophorectomy for the prevention of BRCA1- and BRCA2-associated breast and gynecologic cancer: a multicenter, prospective study. J Clin Oncol. 2008 Mar 10;26(8):1331-7. doi: 10.1200/JCO.2007.13.9626. Epub 2008 Feb 11. |
| 12023993 | Background | Rebbeck TR, Lynch HT, Neuhausen SL, Narod SA, Van't Veer L, Garber JE, Evans G, Isaacs C, Daly MB, Matloff E, Olopade OI, Weber BL; Prevention and Observation of Surgical End Points Study Group. Prophylactic oophorectomy in carriers of BRCA1 or BRCA2 mutations. N Engl J Med. 2002 May 23;346(21):1616-22. doi: 10.1056/NEJMoa012158. Epub 2002 May 20. |
| D004701 |
| Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |