A Study of the Communication of Genetic Test Results By Telephone: A Multi-Center Study

A Study of the Communication of Genetic Test Results by Telephone: a Multi-center Study

Sponsors

Lead Sponsor: Abramson Cancer Center of the University of Pennsylvania

Source Abramson Cancer Center of the University of Pennsylvania
Brief 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.

Detailed Description

Basic science advances in genomics have provided great promise for improving human health and reducing the burden of cancer in the United States. The recent successes in genome-wide association studies (GWAS) and related technologies in identifying genetic changes associated with a variety of common diseases have fueled the rapidly growing field of personalized medicine. The promise of personalized medicine is the ability to tailor the treatment or screening of individual patients based on their genotype. Many have highlighted the urgent need for multidisciplinary translational research that focuses on how to advance gene discoveries into effective clinical applications. Genetic screening for cancer susceptibility, one application of personalized medicine, has become a standard evidence-based practice in cancer prevention. Given the complexity of genetic information and the potential social and psychological sequellae, two in-person visits (e.g. pre-test and post-test counseling) with genetic specialists are recommended for delivery of genetic testing for cancer susceptibility. With an increasing demand for genetic services, the two in-person visit delivery model presents barriers to widespread dissemination of genetic testing for disease susceptibility. Innovative delivery models for effective, efficient genetic risk communication that result in behavior change are needed. Telephone delivery of genetic services is one innovative and efficient delivery model that has the potential to expand genetic services to diverse clinical systems and address the insufficient genetic workforce as an increasing number of genetic applications enter clinical practice. While providers and patients identify advantages to telephone delivery of genetic services, they also recognize potential disadvantages particularly in the setting of a positive test result. Thus, evaluation of the psychosocial and behavioral impact of innovations to genetic service delivery (i.e. telephone communication) in diverse populations and among vulnerable subgroups are needed to optimize the health benefits, and minimize the risks of broad dissemination of clinical genetic testing for cancer susceptibility.

The goal of this research is to evaluate the psychological, behavioral and economic outcomes (i.e. risks and benefits) of an innovative and efficient delivery model of genetic services, telephone communication, as compared to the current standard, in-person communication of genetic test results. The investigators expect this research to inform evidence based practice guidelines and potentially change the paradigm of delivery of genetic services for disease susceptibility.

Overall Status Completed
Start Date November 2012
Completion Date November 2015
Primary Completion Date November 2015
Study Type Observational
Primary Outcome
Measure Time Frame
Number of telephone surveys completed 3 years
Enrollment 289
Condition
Intervention

Intervention Type: Genetic

Intervention Name: Genetic Providers

Description: Genetic providers (genetic counselors or nurses) will follow the standardized disclosure protocol for in-person and telephone disclosures whle completing a disclosure flow checklist.

Intervention Type: Other

Intervention Name: Visual Aids

Description: 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.

Intervention Type: Other

Intervention Name: Post-Disclosure Asessments

Description: 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.

Intervention Type: Other

Intervention Name: In-person Clinical Follow-Up

Description: 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

Arm Group Label: In Person Disclosure

Intervention Type: Other

Intervention Name: 6 Month and 12 Month Assessments

Description: At 6 months and 12 months after disclosure participants will be asked to complete survey assessments.

Eligibility

Sampling Method: Probability Sample

Criteria:

Inclusion Criteria:

- Engligh speaking Male or Female Completed in person pretest counseling Decided to have blood drawn for clinical BRCA 1/2 Age 18 or older

Exclusion Criteria:

-

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Angela Bradbury, MD Principal Investigator Abramson Cancer Center of the University of Pennsylvania
Location
Facility:
The John H. Stroger Jr. Hospital of Cook County | Chicago, Illinois, United States
The University of Chicago | Chicago, Illinois, United States
MD Anderson Cancer Center at Cooper | Camden, New Jersey, United States
Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania, 19104, United States
The Fox Chase Cancer Center | Philadelphia, Pennsylvania, United States
Location Countries

United States

Verification Date

July 2017

Responsible Party

Type: Sponsor

Has Expanded Access No
Arm Group

Label: Telephone Disclosure

Description: Telephone Disclosure: Participants randomized to telephone disclosure will be asked to provide a personal identifier that the participant will be asked at the time of their telephone disclosure to ensure their identity.

Label: In Person Disclosure

Description: Individuals opting out of randomization but still willing to participate in the research will be placed in the self-select in-person arm.

Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov