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Telemedicine vs. Face-to-Face Cancer Genetic Counseling
This study is currently recruiting participants.
Verified by Duke University, November 2008
Sponsors and Collaborators: Duke University
Susan G. Komen Breast Cancer Foundation
Information provided by: Duke University
ClinicalTrials.gov Identifier: NCT00609505
  Purpose

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 Intervention
Hereditary Breast and Ovarian Cancer Syndrome
Other Hereditary Breast Cancer Syndromes
Other: Telemedicine
Other: Face-to-Face

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer Genetic Counseling Ovarian Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Health Services Research, Randomized, Open Label, Parallel Assignment
Official Title: Telemedicine vs. Face-to-Face Cancer Genetic Counseling in Rural Oncology Clinics

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Patient satisfaction [ Time Frame: One week post-intervention (genetic counseling session) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cost-effectiveness [ Time Frame: Enrollment completion ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: August 2008
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
TM
Telemedicine genetic counseling group
Other: Telemedicine
Telemedicine genetic counseling
FTF
Face-to-face genetic counseling group
Other: Face-to-Face
Face-to-face genetic counseling

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00609505

Contacts
Contact: Martha B Adams, M.D., M.A. 919-681-2452 martha.adams@duke.edu
Contact: Adam H Buchanan, M.S., M.P.H. 919-668-0766 adam.buchanan@duke.edu

Locations
United States, North Carolina
Maria Parham Medical Center Recruiting
Henderson, North Carolina, United States, 27536
Johnston Cancer Center Recruiting
Smithfield, North Carolina, United States, 27577
Gibson Cancer Center Not yet recruiting
Lumberton, North Carolina, United States, 28358
Scotland Cancer Treatment Center Not yet recruiting
Laurinburg, North Carolina, United States, 28352
Sponsors and Collaborators
Duke University
Susan G. Komen Breast Cancer Foundation
Investigators
Principal Investigator: Martha B Adams, M.D., M.A. Duke University
  More Information

Duke Hereditary Cancer Clinic website  This link exits the ClinicalTrials.gov site
Duke Oncology Network website  This link exits the ClinicalTrials.gov site

Responsible Party: Duke University Medical Center ( Martha Adams, M.D./Vice Chair for Clinical Affairs, Dept. of Medicine )
Study ID Numbers: Pro00001547, DISP0707781
Study First Received: January 25, 2008
Last Updated: November 6, 2008
ClinicalTrials.gov Identifier: NCT00609505  
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Hereditary Breast and Ovarian Cancer syndrome
genetic counseling
breast cancer
ovarian cancer
telemedicine
Cancer genetic counseling

Study placed in the following topic categories:
Ovarian cancer
Ovarian Neoplasms
Facies
Skin Diseases
Gonadal Disorders
Genital Neoplasms, Female
Breast Neoplasms
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Genital Diseases, Female
Endocrinopathy
Breast Diseases
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Pathologic Processes
Disease
Neoplasms by Site
Syndrome
Adnexal Diseases

ClinicalTrials.gov processed this record on January 16, 2009