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Sponsors and Collaborators: |
Duke University Susan G. Komen Breast Cancer Foundation |
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Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00609505 |
Cancer genetic counseling (CGC) has been found to have "substantial" benefits for individuals with breast cancer and their family members; it has been deemed by multiple organizations as "standard of care" for women with breast cancer and their relatives. Unfortunately, there is a disparity in access to CGC, especially among women who live in rural and underserved areas. In North Carolina, only two cancer genetic counselors practice in rural clinics - each only for a few days per month. Therefore, in an effort to make CGC more widely available in a timely manner, we propose to test provision of counseling through telemedicine (TM), in which a patient and health care provider communicate with each other using videoconferencing. In 4 rural oncology clinics, we will implement low-cost TM and compare satisfaction and cost-effectiveness between groups of women designated to have their CGC session by TM or FTF. We'll use a validated measure to assess satisfaction by a phone survey one week after the CGC appointment; cost-effectiveness will be measured at project's end by calculating length of wait time for appointment and costs of equipment, labor, and mileage. Study hypothesis: TM is as satisfactory as FTF counseling and is a more cost-effective way to provide this beneficial service.
Condition | Intervention |
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Hereditary Breast and Ovarian Cancer Syndrome Other Hereditary Breast Cancer Syndromes |
Other: Telemedicine Other: Face-to-Face |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Open Label, Parallel Assignment |
Official Title: | Telemedicine vs. Face-to-Face Cancer Genetic Counseling in Rural Oncology Clinics |
Estimated Enrollment: | 120 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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TM
Telemedicine genetic counseling group
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Other: Telemedicine
Telemedicine genetic counseling
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FTF
Face-to-face genetic counseling group
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Other: Face-to-Face
Face-to-face genetic counseling
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Martha B Adams, M.D., M.A. | 919-681-2452 | martha.adams@duke.edu |
Contact: Adam H Buchanan, M.S., M.P.H. | 919-668-0766 | adam.buchanan@duke.edu |
United States, North Carolina | |
Maria Parham Medical Center | Recruiting |
Henderson, North Carolina, United States, 27536 | |
Johnston Cancer Center | Recruiting |
Smithfield, North Carolina, United States, 27577 | |
Gibson Cancer Center | Not yet recruiting |
Lumberton, North Carolina, United States, 28358 | |
Scotland Cancer Treatment Center | Not yet recruiting |
Laurinburg, North Carolina, United States, 28352 |
Principal Investigator: | Martha B Adams, M.D., M.A. | Duke University |
Responsible Party: | Duke University Medical Center ( Martha Adams, M.D./Vice Chair for Clinical Affairs, Dept. of Medicine ) |
Study ID Numbers: | Pro00001547, DISP0707781 |
Study First Received: | January 25, 2008 |
Last Updated: | November 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00609505 |
Health Authority: | United States: Institutional Review Board |
Hereditary Breast and Ovarian Cancer syndrome genetic counseling breast cancer |
ovarian cancer telemedicine Cancer genetic counseling |
Ovarian cancer Ovarian Neoplasms Facies Skin Diseases Gonadal Disorders Genital Neoplasms, Female Breast Neoplasms |
Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Genital Diseases, Female Endocrinopathy Breast Diseases Endocrine Gland Neoplasms |
Neoplasms Pathologic Processes Disease |
Neoplasms by Site Syndrome Adnexal Diseases |