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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01736345 on ClinicalTrials.gov