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

Purpose

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.

Condition	Intervention
Candidates for BRCA 1/2 Genetic Testing	Genetic: Genetic Providers Other: Visual Aids Other: Post-Disclosure Asessments Other: In-person Clinical Follow-Up Other: 6 Month and 12 Month Assessments

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	A Study of the Communication of Genetic Test Results by Telephone: a Multi-center Study

Resource links provided by NLM:

MedlinePlus related topics: Genetic Testing

U.S. FDA Resources

Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Primary Outcome Measures:

Number of participants with adverse events [ Designated as safety issue: Yes ]

Estimated Enrollment:	600
Study Start Date:	November 2012
Estimated Study Completion Date:	November 2015
Estimated Primary Completion Date:	November 2015 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Telephone Disclosure 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.	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: 6 Month and 12 Month Assessments At 6 months and 12 months after disclosure participants will be asked to complete survey assessments.
In Person Disclosure Individuals opting out of randomization but still willing to participate in the research will be placed in the self-select in-person arm.	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.

Groups/Cohorts

Assigned Interventions

Telephone Disclosure

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.

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: 6 Month and 12 Month Assessments

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

In Person Disclosure

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

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.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
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

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:

-

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01736345

Contacts

Contact: Angela Bradbury, MD

855-216-0098

PennCancerTrials@emergingmed.com

Locations

United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Angela Bradbury, MD 855-216-0098 PennCancerTrials@emergingmed.com
Principal Investigator: Angela Bradbury, MD

Sponsors and Collaborators

Abramson Cancer Center of the University of Pennsylvania

Investigators

Principal Investigator:

Angela Bradbury, MD

Abramson Cancer Center of the University of Pennsylvania

More Information

No publications provided

Responsible Party:	Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT01736345 History of Changes
Other Study ID Numbers:	UPCC 29112
Study First Received:	November 14, 2012
Last Updated:	February 26, 2013
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 16, 2013