Risk Education and Assessment for Cancer Heredity

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Bridging Geographic Barriers: Remote Cancer Genetic Counseling for Rural Women

Conditions
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Breast Cancer, Ovarian Cancer, Genetic Predisposition

Intervention / Treatment
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* Behavioral: Telephone Genetic Counseling
* Behavioral: In-Person Genetic Counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telephone genetic counseling<br>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<br>* 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.<br>* Other names: BRCA1/BRCA2 genetic counseling via telephone;|
| Active Comparator: In-person genetic counseling<br>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<br>* 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.<br>* Other names: BRCA1/BRCA2 traditional genetic counseling in-person;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the non-inferiority/equivalency of telephone genetic counseling to standard in-person genetic counseling | 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. | 6 &12-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the feasibility of the intervention | 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. | 1 week pre-test, 1 week post-test, 6 & 12 month follow-ups | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Genetic Counseling, Genetic Counseling Interventions, Genetic Testing, BRCA1 gene, BRCA2 gene, Risk Communication