Telemedicine vs. Face-to-Face Cancer Genetic Counseling
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Purpose
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 |
|---|---|
|
Hereditary Breast and Ovarian Cancer Syndrome Lynch Syndrome |
Other: Telemedicine Other: Face-to-Face |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Telemedicine vs. Face-to-Face Cancer Genetic Counseling in Rural Oncology Clinics |
- Patient satisfaction [ Time Frame: One week post-intervention (genetic counseling session) ] [ Designated as safety issue: No ]
- Cost-effectiveness [ Time Frame: Enrollment completion ] [ Designated as safety issue: No ]
| Enrollment: | 130 |
| Study Start Date: | August 2008 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
TM
Telemedicine genetic counseling group
|
Other: Telemedicine
Telemedicine genetic counseling
|
|
FTF
Face-to-face genetic counseling group
|
Other: Face-to-Face
Face-to-face genetic counseling
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| United States, North Carolina | |
| Maria Parham Medical Center | |
| Henderson, North Carolina, United States, 27536 | |
| Scotland Cancer Treatment Center | |
| Laurinburg, North Carolina, United States, 28352 | |
| Gibson Cancer Center | |
| Lumberton, North Carolina, United States, 28358 | |
| Johnston Cancer Center | |
| Smithfield, North Carolina, United States, 27577 | |
| Principal Investigator: | Martha B Adams, M.D., M.A. | Duke University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT00609505 History of Changes |
| Other Study ID Numbers: | Pro00001547, DISP0707781 |
| Study First Received: | January 25, 2008 |
| Last Updated: | February 21, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Duke University:
|
Hereditary Breast and Ovarian Cancer syndrome genetic counseling breast cancer |
ovarian cancer telemedicine Cancer genetic counseling |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Colorectal Neoplasms, Hereditary Nonpolyposis Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders |
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplastic Syndromes, Hereditary Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Genetic Diseases, Inborn DNA Repair-Deficiency Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on May 21, 2013