Risk Education and Assessment for Cancer Heredity (REACH)

April 12, 2016 updated by: Anita Kinney, University of Utah

Bridging Geographic Barriers: Remote Cancer Genetic Counseling for Rural Women

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Following confirmation of eligibility and completion of baseline surveys, participants will be randomly assigned to one of the study arms by the project coordinator, using a computer-generated allocation algorithm on the basis of a randomization blocks method using four, six or eight participants in each block.

In-person and telephone counseling will be delivered by the same board-certified genetic counselors using a guideline-concordant semi-structured protocol that will allow for personalization of counseling.

Participants randomly assigned to telephone counseling will be mailed packets that include a sealed envelope containing an educational brochure about hereditary breast and ovarian cancer genetic counseling with visual aids. At the time of their session, participants will review the brochure and genetic counselors will use visual aids to explain breast-ovarian cancer genetics. Women receiving in-person counseling will be given the same materials during their session at the community clinic.

For women who elect to have testing, those who have telephone counseling will be sent a genetic test kit; those who have in-person counseling will have the option of giving a sample immediately at the clinic, or will be given a test kit with the same instructions as those in the telephone-counseling group.

When BRCA test results become available, participants will be offered individual post-test counseling with the same genetic counselor who conducted the pretest session.

Study Type

Interventional

Enrollment (Actual)

1012

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84118
        • Huntsman Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telephone genetic counseling
Participants randomly assigned to telephone counseling are mailed packets that included a sealed envelope containing an educational brochure about hereditary breast and ovarian cancer (HBOC) genetic counseling with visual aids. At the time of their session, participants open their envelope and counselors use the visual aids to explain breast-ovarian cancer genetics and administer BRCA1/BRCA2 genetic counseling. Women receiving in-person counseling are given these same materials during their session at the community clinic. In-person and telephone counseling are delivered by the same five board-certified genetic counselors.
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.
Other Names:
  • BRCA1/BRCA2 genetic counseling via telephone
Active Comparator: In-person genetic counseling
In-person BRCA1/BRCA2 genetic counseling is delivered by board-certified genetic counselors using a guide-line-concordant semistructured protocol that allows for personalization of counseling and is similar to that used by others. All sessions are audiotaped for treatment fidelity assessments. In-person and telephone counseling are delivered by the same five board-certified genetic counselors.
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.
Other Names:
  • BRCA1/BRCA2 traditional genetic counseling in-person

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the non-inferiority/equivalency of telephone genetic counseling to standard in-person genetic counseling
Time Frame: 6 &12-month follow-up
  1. Compare utilization of BRCA1/BRCA2 testing among telephone genetic counseling relative to in-person genetic counseling.
  2. Determine the safety and efficacy of telephone genetic counseling relative to in-person genetic counseling by evaluating psychological and quality of life outcomes.
  3. Compare communication-related and decision-making outcomes among telephone genetic counseling relative to in-person genetic counseling.
6 &12-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the feasibility of the intervention
Time Frame: 1 week pre-test, 1 week post-test, 6 & 12 month follow-ups
  1. Examine the intervention delivery and patient costs of telephone genetic counseling relative to in-person genetic counseling.
  2. Examine mediators (sociodemographic, communication factors, health care access, clinical, & psychosocial factors) of genetic testing decisions, and affective and cognitive outcomes.
  3. Compare decisions and perceptions about use of primary/secondary prevention strategies for hereditary breast/ovarian cancer.
1 week pre-test, 1 week post-test, 6 & 12 month follow-ups

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Anita Y. Kinney, R.N., Ph.D., University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

April 29, 2011

First Submitted That Met QC Criteria

May 2, 2011

First Posted (Estimate)

May 3, 2011

Study Record Updates

Last Update Posted (Estimate)

April 14, 2016

Last Update Submitted That Met QC Criteria

April 12, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23146
  • 1R01CA129142-01A2 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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