A Study of the Communication of Genetic Test Results By Telephone: A Multi-Center Study
NCT ID: NCT01736345
Last Updated: 2022-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
289 participants
OBSERVATIONAL
2012-12-03
2015-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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 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.
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.
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.
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 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.
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.
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.
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
6 Month and 12 Month Assessments
At 6 months and 12 months after disclosure participants will be asked to complete survey assessments.
Interventions
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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.
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.
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.
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
6 Month and 12 Month Assessments
At 6 months and 12 months after disclosure participants will be asked to complete survey assessments.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Abramson Cancer Center at Penn Medicine
OTHER
Responsible Party
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Principal Investigators
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Angela Bradbury, MD
Role: PRINCIPAL_INVESTIGATOR
Abramson Cancer Center at Penn Medicine
Locations
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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, United States
The Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Countries
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References
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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.
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.
Other Identifiers
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UPCC 29112
Identifier Type: -
Identifier Source: org_study_id
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