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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


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
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