Telemedicine vs. Face-to-Face Cancer Genetic Counseling

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00609505
Recruitment Status : Completed
First Posted : February 7, 2008
Last Update Posted : February 22, 2012
Susan G. Komen Breast Cancer Foundation
Information provided by (Responsible Party):
Duke University

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
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 : August 2008
Actual Primary Completion Date : March 2011
Actual Study Completion Date : April 2011

Arm Intervention/treatment
Telemedicine genetic counseling group
Other: Telemedicine
Telemedicine genetic counseling

Face-to-face genetic counseling group
Other: Face-to-Face
Face-to-face genetic counseling

Primary Outcome Measures :
  1. Patient satisfaction [ Time Frame: One week post-intervention (genetic counseling session) ]

Secondary Outcome Measures :
  1. Cost-effectiveness [ Time Frame: Enrollment completion ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00609505

United States, North Carolina
Maria Parham Medical Center
Henderson, North Carolina, United States, 27536
Scotland Cancer Treatment Center
Laurinburg, North Carolina, United States, 28352
Gibson Cancer Center
Lumberton, North Carolina, United States, 28358
Johnston Cancer Center
Smithfield, North Carolina, United States, 27577
Sponsors and Collaborators
Duke University
Susan G. Komen Breast Cancer Foundation
Principal Investigator: Martha B Adams, M.D., M.A. Duke University

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Duke University Identifier: NCT00609505     History of Changes
Other Study ID Numbers: Pro00001547
First Posted: February 7, 2008    Key Record Dates
Last Update Posted: February 22, 2012
Last Verified: February 2012

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

Additional relevant MeSH terms:
Ovarian Neoplasms
Colorectal Neoplasms, Hereditary Nonpolyposis
Hereditary Breast and Ovarian Cancer Syndrome
Pathologic Processes
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplastic Syndromes, Hereditary
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders
Metabolic Diseases
Breast Neoplasms
Breast Diseases