Lynch Syndrome Clinical Trial
Official title:
Telemedicine vs. Face-to-Face Cancer Genetic Counseling in Rural Oncology Clinics
Verified date | February 2012 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 130 |
Est. completion date | April 2011 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Individuals referred for cancer genetic counseling (e.g., by medical oncologist, primary care physician or self) in one of 4 oncology clinics: Gibson Cancer Center in Lumberton, NC; Scotland Cancer Treatment Center in Laurinburg, NC; Johnston Cancer Center in Smithfield, NC; and Maria Parham Cancer Center in Henderson, NC. - Willing to be randomized to receive counseling via telemedicine or face-to-face. Exclusion Criteria: - Referred for cancer genetic counseling from any clinic other than the 4 listed above. - Unwilling to be randomized to receive counseling via telemedicine or face-to-face. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
United States | Maria Parham Medical Center | Henderson | North Carolina |
United States | Scotland Cancer Treatment Center | Laurinburg | North Carolina |
United States | Gibson Cancer Center | Lumberton | North Carolina |
United States | Johnston Cancer Center | Smithfield | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University | Susan G. Komen Breast Cancer Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient satisfaction | One week post-intervention (genetic counseling session) | No | |
Secondary | Cost-effectiveness | Enrollment completion | No |
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