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Risk Education and Assessment for Cancer Heredity (REACH)

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Anita Kinney, University of Utah
ClinicalTrials.gov Identifier:
NCT01346761
First received: April 29, 2011
Last updated: April 12, 2016
Last verified: April 2016
  Purpose
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.

Condition Intervention
Breast Cancer
Ovarian Cancer
Genetic Predisposition
Behavioral: Telephone Genetic Counseling
Behavioral: In-Person Genetic Counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Bridging Geographic Barriers: Remote Cancer Genetic Counseling for Rural Women

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Determine the non-inferiority/equivalency of telephone genetic counseling to standard in-person genetic counseling [ Time Frame: 6 &12-month follow-up ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Determine the feasibility of the intervention [ Time Frame: 1 week pre-test, 1 week post-test, 6 & 12 month follow-ups ] [ Designated as safety issue: No ]
    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.


Enrollment: 1012
Study Start Date: August 2009
Study Completion Date: December 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: BRCA1/BRCA2 traditional genetic counseling in-person

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.

  Eligibility

Ages Eligible for Study:   25 Years to 74 Years   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01346761

Locations
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84118
Sponsors and Collaborators
University of Utah
National Cancer Institute (NCI)
Investigators
Principal Investigator: Anita Y. Kinney, R.N., Ph.D. University of Utah
  More Information

Additional Information:
Responsible Party: Anita Kinney, Professor, University of Utah
ClinicalTrials.gov Identifier: NCT01346761     History of Changes
Other Study ID Numbers: 23146  1R01CA129142-01A2 
Study First Received: April 29, 2011
Last Updated: April 12, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
Genetic Counseling
Genetic Counseling Interventions
Genetic Testing
BRCA1 gene
BRCA2 gene
Risk Communication

Additional relevant MeSH terms:
Disease Susceptibility
Genetic Predisposition to Disease
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on December 02, 2016