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

This study is currently recruiting participants.
Verified February 2013 by Abramson Cancer Center of the University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01736345
First received: November 14, 2012
Last updated: February 26, 2013
Last verified: February 2013

November 14, 2012
February 26, 2013
November 2012
November 2015   (final data collection date for primary outcome measure)
Number of participants with adverse events [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01736345 on ClinicalTrials.gov Archive Site
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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

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

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

Candidates for BRCA 1/2 Genetic Testing
  • 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.
  • 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.
    Interventions:
    • Genetic: Genetic Providers
    • Other: Visual Aids
    • Other: Post-Disclosure Asessments
    • Other: 6 Month and 12 Month 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.
    Interventions:
    • Genetic: Genetic Providers
    • Other: Visual Aids
    • Other: Post-Disclosure Asessments
    • Other: In-person Clinical Follow-Up
    • Other: 6 Month and 12 Month Assessments
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
November 2015
November 2015   (final data collection date for primary outcome measure)

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:

-

Both
18 Years and older
Yes
Contact: Angela Bradbury, MD 855-216-0098 PennCancerTrials@emergingmed.com
United States
 
NCT01736345
UPCC 29112
Yes
Abramson Cancer Center of the University of Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Not Provided
Principal Investigator: Angela Bradbury, MD Abramson Cancer Center of the University of Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP