Clinical trial NCT01736345: A Study of the Communication of Genetic Test Results By Telephone: A Multi-Center Study
Official title: A Study of the Communication of Genetic Test Results by Telephone: a Multi-center Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Candidates for BRCA 1/2 Genetic Testing
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2012-11-29
Enrollment: 289
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Engligh speaking Male or Female Completed in person pretest counseling Decided to have blood drawn for clinical BRCA 1/2 Age 18 or older

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.

Eligibility 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:

-

Primary outcomes:
measure: Number of telephone surveys completed
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The John H. Stroger Jr. Hospital of Cook County
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
city: Camden
country: United States
facility: MD Anderson Cancer Center at Cooper
state: New Jersey
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: The Fox Chase Cancer Center
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Angela Bradbury, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beri N, Patrick-Miller LJ, Egleston BL, Hall MJ, Domchek SM, Daly MB, Ganschow P, Grana G, Olopade OI, Fetzer D, Brandt A, Chambers R, Clark DF, Forman A, Gaber R, Gulden C, Horte J, Long J, Lucas T, Madaan S, Mattie K, McKenna D, Montgomery S, Nielsen S, Powers J, Rainey K, Rybak C, Savage M, Seelaus C, Stoll J, Stopfer JE, Yao XS, Bradbury AR. Preferences for in-person disclosure: Patients declining telephone disclosure characteristics and outcomes in the multicenter Communication Of GENetic Test Results by Telephone study. Clin Genet. 2019 Feb;95(2):293-301. doi: 10.1111/cge.13474. Epub 2018 Dec 7.
citation: Bradbury AR, Patrick-Miller LJ, Egleston BL, Hall MJ, Domchek SM, Daly MB, Ganschow P, Grana G, Olopade OI, Fetzer D, Brandt A, Chambers R, Clark DF, Forman A, Gaber R, Gulden C, Horte J, Long JM, Lucas T, Madaan S, Mattie K, McKenna D, Montgomery S, Nielsen S, Powers J, Rainey K, Rybak C, Savage M, Seelaus C, Stoll J, Stopfer JE, Yao XS. Randomized Noninferiority Trial of Telephone vs In-Person Disclosure of Germline Cancer Genetic Test Results. J Natl Cancer Inst. 2018 Sep 1;110(9):985-993. doi: 10.1093/jnci/djy015.