Telemedicine vs. Face-to-Face Cancer Genetic Counseling

This study has been completed.
Sponsor:
Collaborator:
Susan G. Komen Breast Cancer Foundation
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00609505
First received: January 25, 2008
Last updated: February 21, 2012
Last verified: February 2012
  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
Lynch Syndrome
Other: Telemedicine
Other: Face-to-Face

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Telemedicine vs. Face-to-Face Cancer Genetic Counseling in Rural Oncology Clinics

Resource links provided by NLM:


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 ]

Enrollment: 130
Study Start Date: August 2008
Study Completion Date: April 2011
Primary Completion Date: March 2011 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00609505

Locations
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
Investigators
Principal Investigator: Martha B Adams, M.D., M.A. Duke University
  More Information

Additional Information:
No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00609505     History of Changes
Other Study ID Numbers: Pro00001547, DISP0707781
Study First Received: January 25, 2008
Last Updated: February 21, 2012
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

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

ClinicalTrials.gov processed this record on August 26, 2014