Telemedicine vs. Face-to-Face Cancer Genetic Counseling

NCT00609505 | Completed

• 2 other identifiers: Pro00001547DISP0707781
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Patient satisfaction

  One week post-intervention (genetic counseling session)

Secondary Outcomes (1)

• Cost-effectiveness

  Enrollment completion

Study Arms (2)

TM

OTHER

Telemedicine genetic counseling group

Other: Telemedicine

FTF

OTHER

Face-to-face genetic counseling group

Other: Face-to-Face

Interventions

Telemedicine OTHER

Telemedicine genetic counseling

TM

Face-to-Face OTHER

Face-to-face genetic counseling

FTF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• Susan G. Komen Breast Cancer Foundation: collaborator

Study Sites (4)

Maria Parham Medical Center

Henderson, North Carolina, 27536, United States

Location

Scotland Cancer Treatment Center

Laurinburg, North Carolina, 28352, United States

Location

Gibson Cancer Center

Lumberton, North Carolina, 28358, United States

Location

Johnston Cancer Center

Smithfield, North Carolina, 27577, United States

Location

Related Publications (1)

• 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.

  PMID: 25833335 DERIVED

Related Links

• Duke Hereditary Cancer Clinic website
• Duke Oncology Network website

MeSH Terms

Conditions

Hereditary Breast and Ovarian Cancer Syndrome; Colorectal Neoplasms, Hereditary Nonpolyposis; Breast Neoplasms; Ovarian Neoplasms

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Neoplastic Syndromes, Hereditary; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine System Diseases; Gonadal Disorders; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Martha B Adams, M.D., M.A.

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2008
• First Posted: February 7, 2008
• Study Start: August 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: April 1, 2011
• Last Updated: February 22, 2012

Record last verified: 2012-02

Locations

US (4)