Telemedicine vs. Face-to-Face Cancer Genetic Counseling

Not Applicable

Completed

• Conditions: Hereditary Breast and Ovarian Cancer Syndrome; Lynch Syndrome
• Interventions: Other: Telemedicine; Other: Face-to-Face

• Registration Number: NCT00609505
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-01-25
• Study First Submitted QC: 2008-02-06
• Study First Posted: 2008-02-07
• Study Start: 2008-08
• Primary Completion: 2011-03
• Study Completion: 2011-04
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-21
• Last Update Posted: 2012-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TM	Telemedicine	Telemedicine genetic counseling group
FTF	Face-to-Face	Face-to-face genetic counseling group

Primary Outcome Measures

Name	Time	Method
Patient satisfaction	One week post-intervention (genetic counseling session)

Secondary Outcome Measures

Name	Time	Method
Cost-effectiveness	Enrollment completion

Trial Locations

Locations (4)

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, United States