Overview

This trial is active, not recruiting.

Conditions breast cancer, ovarian cancer, genetic predisposition
Treatment brca1/brca2 genetic counseling
Sponsor University of Utah
Collaborator National Cancer Institute (NCI)
Start date August 2009
End date May 2016
Trial size 1021 participants
Trial identifier NCT01346761, 1R01CA129142-01A2, 23146

Summary

Individuals living in geographically underserved areas encounter considerable barriers to access of quality cancer genetic services. Although in-person genetic counseling has generally been accepted as the standard of care, the use of telecommunications to deliver clinical genetic services may help reduce this disparity in access to such services. However, before the widespread adoption of telephone-delivered cancer genetic services occurs, it is critical to analyze the efficacy and safety of this mode of communication. This two-group randomized equivalency/non-inferiority trial will determine whether telephone-based cancer genetic counseling is an acceptable alternative to the traditional in-person mode among women who have a personal or family history of breast and/or ovarian cancer strong enough to warrant genetic counseling and testing. This study's findings will provide important information to cancer centers and cancer control policies about the safety, efficacy, and costs of delivering telephone-based clinical cancer genetic services for geographically challenged women at risk for having BRCA 1/2 mutations.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose health services research
Arm
(Active Comparator)
brca1/brca2 genetic counseling
Participants will complete a pre-test session and a test results disclosure session (if tested) with a licensed, board-certified genetic counselor either over the telephone or in-person. Counseling sessions will be audiotaped for quality control of intervention.
(Active Comparator)
brca1/brca2 genetic counseling
Participants will complete a pre-test session and a test results disclosure session (if tested) with a licensed, board-certified genetic counselor either over the telephone or in-person. Counseling sessions will be audiotaped for quality control of intervention.

Primary Outcomes

Measure
Determine the non-inferiority/equivalency of telephone genetic counseling to standard in-person genetic counseling
time frame: 12-month follow-up

Secondary Outcomes

Measure
Determine the feasibility of the intervention
time frame: 1 week pre-test, 1 week post-test, 6 & 12 month follow-ups

Eligibility Criteria

Female participants from 25 years up to 74 years old.

Inclusion Criteria: - Utah resident - Meets National Comprehensive Cancer Network (NCCN) guidelines for hereditary breast/ovarian cancer syndrome (personal and/or family history of breast and/or ovarian cancer, or is a member of a family with a known positive BRCA1/BRCA2 mutation). Exclusion Criteria: - Has had genetic counseling and/or BRCA 1/2 testing - Physically or mentally unable to complete telephone surveys, telephone or in-person counseling or provide informed consent. - Unable to read and speak English fluently - Unable to travel to in-person genetic counseling session (17 in-person sites throughout Utah) - Male gender

Additional Information

Official title Bridging Geographic Barriers: Remote Cancer Genetic Counseling for Rural Women
Principal investigator Anita Y. Kinney, R.N., Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by University of Utah.