Risk Education and Assessment for Cancer Heredity

NCT ID: NCT01346761

Last Updated: 2016-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1012 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2012-12-31

Brief 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.

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.

Conditions

Breast Cancer; Ovarian Cancer; Genetic Predisposition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Telephone Genetic Counseling

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

In-Person Genetic Counseling

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

BRCA1/BRCA2 genetic counseling via telephone; BRCA1/BRCA2 traditional genetic counseling in-person

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Anita Kinney

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anita Y. Kinney, R.N., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Countries

United States

References

Steffen LE, Du R, Gammon A, Mandelblatt JS, Kohlmann WK, Lee JH, Buys SS, Stroup AM, Campo RA, Flores KG, Vicuna B, Schwartz MD, Kinney AY. Genetic Testing in a Population-Based Sample of Breast and Ovarian Cancer Survivors from the REACH Randomized Trial: Cost Barriers and Moderators of Counseling Mode. Cancer Epidemiol Biomarkers Prev. 2017 Dec;26(12):1772-1780. doi: 10.1158/1055-9965.EPI-17-0389. Epub 2017 Sep 29.

Reference Type: DERIVED

PMID: 28971986 (View on PubMed)

Kinney AY, Steffen LE, Brumbach BH, Kohlmann W, Du R, Lee JH, Gammon A, Butler K, Buys SS, Stroup AM, Campo RA, Flores KG, Mandelblatt JS, Schwartz MD. Randomized Noninferiority Trial of Telephone Delivery of BRCA1/2 Genetic Counseling Compared With In-Person Counseling: 1-Year Follow-Up. J Clin Oncol. 2016 Aug 20;34(24):2914-24. doi: 10.1200/JCO.2015.65.9557. Epub 2016 Jun 20.

Reference Type: DERIVED

PMID: 27325848 (View on PubMed)

Other Identifiers

1R01CA129142-01A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23146

Identifier Type: -

Identifier Source: org_study_id