Telemedicine vs. Face-to-Face Cancer Genetic Counseling

Lynch Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00609505
• Other study ID #: Pro00001547
• Secondary ID: DISP0707781
• Status: Completed
• Phase: N/A
• First received: January 25, 2008
• Last updated: February 21, 2012
• Start date: August 2008
• Est. completion date: April 2011

Study information

• Verified date: February 2012
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: April 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Hereditary Breast and Ovarian Cancer Syndrome
• Lynch Syndrome
• Ovarian Neoplasms
• Syndrome

Intervention

Other:
• Telemedicine
Telemedicine genetic counseling
• Face-to-Face
Face-to-face genetic counseling

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Susan G. Komen Breast Cancer Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient satisfaction		One week post-intervention (genetic counseling session)	No
Secondary	Cost-effectiveness		Enrollment completion	No

External Links

•   Duke Hereditary Cancer Clinic website
•   Duke Oncology Network website