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Bridging Geographic Barriers: Remote Cancer Genetic Counseling for Rural Women


N/A
25 Years
74 Years
Open (Enrolling)
Female
Breast Cancer, Ovarian Cancer, Genetic Predisposition

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Trial Information

Bridging Geographic Barriers: Remote Cancer Genetic Counseling for Rural Women


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Outcome Measure:

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

Outcome Description:

Compare utilization of BRCA1/BRCA2 testing among telephone genetic counseling relative to in-person genetic counseling. Determine the safety and efficacy of telephone genetic counseling relative to in-person genetic counseling by evaluating psychological and quality of life outcomes. Compare communication-related and decision-making outcomes among telephone genetic counseling relative to in-person genetic counseling.

Outcome Time Frame:

12-month follow-up

Safety Issue:

No

Principal Investigator

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

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Utah

Authority:

United States: Institutional Review Board

Study ID:

23146

NCT ID:

NCT01346761

Start Date:

August 2009

Completion Date:

December 2014

Related Keywords:

  • Breast Cancer
  • Ovarian Cancer
  • Genetic Predisposition
  • Genetic Counseling
  • Genetic Counseling Interventions
  • Genetic Testing
  • BRCA1 gene
  • BRCA2 gene
  • Risk Communication
  • Breast Neoplasms
  • Disease Susceptibility
  • Ovarian Neoplasms

Name

Location

Huntsman Cancer InstituteSalt Lake City, Utah  84112