Telemedicine vs. Face-to-Face Cancer Genetic Counseling

Sponsor

Duke University (Other)

Overall Status

Completed

CT.gov ID

NCT00609505

Collaborator

Susan G. Komen Breast Cancer Foundation (Other)

130

Enrollment

Locations

Arms

Duration (Months)

32.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hereditary Breast and Ovarian Cancer Syndrome Lynch Syndrome	Other: Telemedicine Other: Face-to-Face	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

130 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Study Start Date :

Aug 1, 2008

Actual Primary Completion Date :

Mar 1, 2011

Actual Study Completion Date :

Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Other: TM Telemedicine genetic counseling group	Other: Telemedicine Telemedicine genetic counseling
Other: FTF Face-to-face genetic counseling group	Other: Face-to-Face Face-to-face genetic counseling

Arm

Intervention/Treatment

Other: TM

Telemedicine genetic counseling group

Other: Telemedicine

Telemedicine genetic counseling

Other: FTF

Face-to-face genetic counseling group

Other: Face-to-Face

Face-to-face genetic counseling

Outcome Measures

Primary Outcome Measures

Patient satisfaction [One week post-intervention (genetic counseling session)]

Secondary Outcome Measures

Cost-effectiveness [Enrollment completion]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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

Locations

	Site	City	State	Country	Postal Code
1	Maria Parham Medical Center	Henderson	North Carolina	United States	27536
2	Scotland Cancer Treatment Center	Laurinburg	North Carolina	United States	28352
3	Gibson Cancer Center	Lumberton	North Carolina	United States	28358
4	Johnston Cancer Center	Smithfield	North Carolina	United States	27577