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Risk Education and Assessment for Cancer Heredity

NCT01346761 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1012

Last updated 2016-04-14

No results posted yet for this study

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 Breast Cancer susceptibility gene (BRCA) 1/2 mutations.

Conditions

Interventions

BEHAVIORAL

Telephone Genetic Counseling

Participants will complete a pre-test session and a test results disclosure session (if tested) with a licensed, board-certified genetic counselor over the telephone. Counseling sessions will be audiotaped for quality control of intervention.

BEHAVIORAL

In-Person Genetic Counseling

Participants will complete a pre-test session and a test results disclosure session (if tested) with a licensed, board-certified genetic counselor in person. Counseling sessions will be audiotaped for quality control of intervention.

Sponsors & Collaborators

Principal Investigators

  • Anita Y. Kinney, R.N., Ph.D. · University of Utah

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
74 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2012-09-30
Completion
2012-12-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01346761 on ClinicalTrials.gov