Risk Education and Assessment for Cancer Heredity (REACH)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01346761|
Recruitment Status : Completed
First Posted : May 3, 2011
Last Update Posted : April 14, 2016
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Ovarian Cancer Genetic Predisposition||Behavioral: Telephone Genetic Counseling Behavioral: In-Person Genetic Counseling||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1012 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||Bridging Geographic Barriers: Remote Cancer Genetic Counseling for Rural Women|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||December 2012|
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
- Determine the non-inferiority/equivalency of telephone genetic counseling to standard in-person genetic counseling [ Time Frame: 6 &12-month follow-up ]
- 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.
- Determine the feasibility of the intervention [ Time Frame: 1 week pre-test, 1 week post-test, 6 & 12 month follow-ups ]
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01346761
|United States, Utah|
|Huntsman Cancer Institute|
|Salt Lake City, Utah, United States, 84118|
|Principal Investigator:||Anita Y. Kinney, R.N., Ph.D.||University of Utah|