Risk Education and Assessment for Cancer Heredity (REACH)
This study is ongoing, but not recruiting participants.
Sponsor:
University of Utah
Collaborator:
Information provided by (Responsible Party):
Anita Kinney, University of Utah
ClinicalTrials.gov Identifier:
NCT01346761
First received: April 29, 2011
Last updated: March 13, 2013
Last verified: March 2013
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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 ]
- 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.
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 ]
- Examine the intervention delivery and patient costs of telephone genetic counseling relative to in-person genetic counseling.
- Examine mediators (sociodemographic, communication factors, health care access, clinical, & psychosocial factors) of genetic testing decisions, and affective and cognitive outcomes.
- 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 2014 |
| Estimated Primary Completion Date: | May 2014 (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
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: | March 13, 2013 |
| 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 Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Disease Attributes |
Pathologic Processes Endocrine Gland Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders |
ClinicalTrials.gov processed this record on June 18, 2013