Risk Education and Assessment for Cancer Heredity

NCT01346761 | Completed DMC

• 2 other identifiers: 231461R01CA129142-01A2
• Study Type: interventional
• Target: 1,012
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Ovarian Cancer; Genetic Predisposition

Keywords

Genetic Counseling; Genetic Counseling Interventions; Genetic Testing; BRCA1 gene; BRCA2 gene; Risk Communication

Outcome Measures

Primary Outcomes (1)

• Determine the non-inferiority/equivalency of telephone genetic counseling to standard in-person genetic counseling

  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 Outcomes (1)

• Determine the feasibility of the intervention

  1 week pre-test, 1 week post-test, 6 & 12 month follow-ups

Study Arms (2)

Telephone genetic counseling

EXPERIMENTAL

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

In-person genetic counseling

ACTIVE COMPARATOR

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

Interventions

Telephone Genetic Counseling 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.

Also known as: BRCA1/BRCA2 genetic counseling via telephone

Telephone genetic counseling

In-Person Genetic Counseling 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.

Also known as: BRCA1/BRCA2 traditional genetic counseling in-person

In-person genetic counseling

Eligibility Criteria

• Age: 25 Years - 74 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84118, United States

Location

Related Publications (2)

• 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.

  PMID: 28971986 DERIVED

• 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.

  PMID: 27325848 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Ovarian Neoplasms; Genetic Predisposition to Disease; Fanconi Anemia, Complementation Group D1

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; 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; Endocrine System Diseases; Gonadal Disorders; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anita Y. Kinney, R.N., Ph.D.

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 29, 2011
• First Posted: May 3, 2011
• Study Start: August 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 14, 2016

Record last verified: 2016-04

Locations

US (1)