Telemedicine vs. Face-to-Face Cancer Genetic Counseling

Study Overview
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Brief Summary
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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.

Official Title
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Telemedicine vs. Face-to-Face Cancer Genetic Counseling in Rural Oncology Clinics

Conditions
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Hereditary Breast and Ovarian Cancer Syndrome, Lynch Syndrome

Intervention / Treatment
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* Other: Telemedicine
* Other: Face-to-Face


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: TM<br>Telemedicine genetic counseling group | Other: Telemedicine<br>* Telemedicine genetic counseling<br>|
| Other: FTF<br>Face-to-face genetic counseling group | Other: Face-to-Face<br>* Face-to-face genetic counseling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction |  | One week post-intervention (genetic counseling session) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-effectiveness |  | Enrollment completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hereditary Breast and Ovarian Cancer syndrome, genetic counseling, breast cancer, ovarian cancer, telemedicine, Cancer genetic counseling