Telemedicine vs. Face-to-Face Cancer Genetic Counseling

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2011-04-30

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.

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Detailed Description

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Conditions

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Hereditary Breast and Ovarian Cancer Syndrome Lynch Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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TM

Telemedicine genetic counseling group

Group Type OTHER

Telemedicine

Intervention Type OTHER

Telemedicine genetic counseling

FTF

Face-to-face genetic counseling group

Group Type OTHER

Face-to-Face

Intervention Type OTHER

Face-to-face genetic counseling

Interventions

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Telemedicine

Telemedicine genetic counseling

Intervention Type OTHER

Face-to-Face

Face-to-face genetic counseling

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes