Telemedicine vs. Face-to-Face Cancer Genetic Counseling
Primary Purpose
Hereditary Breast and Ovarian Cancer Syndrome, Lynch Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telemedicine
Face-to-Face
Sponsored by
About this trial
This is an interventional health services research trial for Hereditary Breast and Ovarian Cancer Syndrome focused on measuring Hereditary Breast and Ovarian Cancer syndrome, genetic counseling, breast cancer, ovarian cancer, telemedicine, Cancer genetic counseling
Eligibility Criteria
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.
Sites / Locations
- Maria Parham Medical Center
- Scotland Cancer Treatment Center
- Gibson Cancer Center
- Johnston Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
TM
FTF
Arm Description
Telemedicine genetic counseling group
Face-to-face genetic counseling group
Outcomes
Primary Outcome Measures
Patient satisfaction
Secondary Outcome Measures
Cost-effectiveness
Full Information
NCT ID
NCT00609505
First Posted
January 25, 2008
Last Updated
February 21, 2012
Sponsor
Duke University
Collaborators
Susan G. Komen Breast Cancer Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00609505
Brief Title
Telemedicine vs. Face-to-Face Cancer Genetic Counseling
Official Title
Telemedicine vs. Face-to-Face Cancer Genetic Counseling in Rural Oncology Clinics
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Susan G. Komen Breast Cancer Foundation
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hereditary Breast and Ovarian Cancer Syndrome, Lynch Syndrome
Keywords
Hereditary Breast and Ovarian Cancer syndrome, genetic counseling, breast cancer, ovarian cancer, telemedicine, Cancer genetic counseling
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TM
Arm Type
Other
Arm Description
Telemedicine genetic counseling group
Arm Title
FTF
Arm Type
Other
Arm Description
Face-to-face genetic counseling group
Intervention Type
Other
Intervention Name(s)
Telemedicine
Intervention Description
Telemedicine genetic counseling
Intervention Type
Other
Intervention Name(s)
Face-to-Face
Intervention Description
Face-to-face genetic counseling
Primary Outcome Measure Information:
Title
Patient satisfaction
Time Frame
One week post-intervention (genetic counseling session)
Secondary Outcome Measure Information:
Title
Cost-effectiveness
Time Frame
Enrollment completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martha B Adams, M.D., M.A.
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maria Parham Medical Center
City
Henderson
State/Province
North Carolina
ZIP/Postal Code
27536
Country
United States
Facility Name
Scotland Cancer Treatment Center
City
Laurinburg
State/Province
North Carolina
ZIP/Postal Code
28352
Country
United States
Facility Name
Gibson Cancer Center
City
Lumberton
State/Province
North Carolina
ZIP/Postal Code
28358
Country
United States
Facility Name
Johnston Cancer Center
City
Smithfield
State/Province
North Carolina
ZIP/Postal Code
27577
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25833335
Citation
Buchanan AH, Datta SK, Skinner CS, Hollowell GP, Beresford HF, Freeland T, Rogers B, Boling J, Marcom PK, Adams MB. Randomized Trial of Telegenetics vs. In-Person Cancer Genetic Counseling: Cost, Patient Satisfaction and Attendance. J Genet Couns. 2015 Dec;24(6):961-70. doi: 10.1007/s10897-015-9836-6. Epub 2015 Apr 3.
Results Reference
derived
Links:
URL
http://www.dukehealth.org/Services/HereditaryCancer/index
Description
Duke Hereditary Cancer Clinic website
URL
http://www.cancer.duke.edu/don/
Description
Duke Oncology Network website
Learn more about this trial
Telemedicine vs. Face-to-Face Cancer Genetic Counseling
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