A Study of the Communication of Genetic Test Results By Telephone: A Multi-Center Study
NCT01736345 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 289
Last updated 2022-07-27
Summary
The overall goal of the proposed research is to evaluate psychosocial and behavioral outcomes (i.e.risks and benefits) of an innovative and efficient delivery model for genetic testing, telephone communication, as an alternative to in-person communication of genetic testing results to inform guidelines regarding the delivery of genetic information in clinical medicine.
Conditions
- Candidates for BRCA 1/2 Genetic Testing
Interventions
- GENETIC
-
Genetic Providers
Genetic providers (genetic counselors or nurses) will follow the standardized disclosure protocol for in-person and telephone disclosures whle completing a disclosure flow checklist.
- OTHER
-
Visual Aids
Visual aids targeted to facilitate communication of genetic test results were developed based on our preliminary studies and modified based on our initial pilot study.
- OTHER
-
Post-Disclosure Asessments
Within 72 hours of completion of disclosures, participants will be asked to complete post-disclosure survey again being the option to complete by the aforementioned means.
- OTHER
-
In-person Clinical Follow-Up
Participants who receive their test results in person will meet with a Physician, Physician Assistant or Nurse Practitioneras part of their in person disclosure session. Participants randomiZed to telephone disclosure will be recommendedto schedule an in-person clinical follow-up appointment with a Physician, Physician Assistant or Nurse Practitioner
- OTHER
-
6 Month and 12 Month Assessments
At 6 months and 12 months after disclosure participants will be asked to complete survey assessments.
Sponsors & Collaborators
-
Abramson Cancer Center at Penn Medicine
lead OTHER
Principal Investigators
-
Angela Bradbury, MD · Abramson Cancer Center at Penn Medicine
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2012-12-03
- Primary Completion
- 2015-11-30
- Completion
- 2015-11-30
Countries
- United States
Study Locations
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