Risk Education and Assessment for Cancer Heredity (REACH)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Anita Kinney, University of Utah
ClinicalTrials.gov Identifier:
NCT01346761
First received: April 29, 2011
Last updated: July 21, 2014
Last verified: July 2014
  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 BRCA 1/2 mutations.


Condition Intervention
Breast Cancer
Ovarian Cancer
Genetic Predisposition
Behavioral: BRCA1/BRCA2 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: 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.


Estimated Enrollment: 1021
Study Start Date: August 2009
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Telephone genetic counseling Behavioral: BRCA1/BRCA2 Genetic Counseling
Participants will complete a pre-test session and a test results disclosure session (if tested) with a licensed, board-certified genetic counselor either over the telephone or in-person. Counseling sessions will be audiotaped for quality control of intervention.
Active Comparator: In-person genetic counseling Behavioral: BRCA1/BRCA2 Genetic Counseling
Participants will complete a pre-test session and a test results disclosure session (if tested) with a licensed, board-certified genetic counselor either over the telephone or in-person. Counseling sessions will be audiotaped for quality control of intervention.

  Eligibility

Ages Eligible for Study:   25 Years to 74 Years
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
Investigators
Principal Investigator: Anita Y. Kinney, R.N., Ph.D. University of Utah
  More Information

Additional Information:
No publications provided

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: July 21, 2014
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:
Breast Neoplasms
Disease Susceptibility
Genetic Predisposition to Disease
Ovarian Neoplasms
Adnexal Diseases
Breast Diseases
Disease Attributes
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Pathologic Processes
Skin Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 21, 2014