Clinical trial NCT00609505: Telemedicine vs. Face-to-Face Cancer Genetic Counseling
Official title: Telemedicine vs. Face-to-Face Cancer Genetic Counseling in Rural Oncology Clinics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hereditary Breast and Ovarian Cancer Syndrome
Lynch Syndrome
Keywords: Hereditary Breast and Ovarian Cancer syndrome
genetic counseling
breast cancer
ovarian cancer
telemedicine
Cancer genetic counseling
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Susan G. Komen Breast Cancer Foundation
First posted: 2008-02-07
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Patient satisfaction
timeFrame: One week post-intervention (genetic counseling session)
Secondary outcomes:
measure: Cost-effectiveness
timeFrame: Enrollment completion
Other outcomes:
Locations:
city: Henderson
country: United States
facility: Maria Parham Medical Center
state: North Carolina
city: Laurinburg
country: United States
facility: Scotland Cancer Treatment Center
state: North Carolina
city: Lumberton
country: United States
facility: Gibson Cancer Center
state: North Carolina
city: Smithfield
country: United States
facility: Johnston Cancer Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Martha B Adams, M.D., M.A.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Buchanan AH, Datta SK, Skinner CS, Hollowell GP, Beresford HF, Freeland T, Rogers B, Boling J, Marcom PK, Adams MB. Randomized Trial of Telegenetics vs. In-Person Cancer Genetic Counseling: Cost, Patient Satisfaction and Attendance. J Genet Couns. 2015 Dec;24(6):961-70. doi: 10.1007/s10897-015-9836-6. Epub 2015 Apr 3.