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

NCT01736345 | Completed DMC

• 1 other identifier: UPCC 29112
• Study Type: observational
• Target: 289
• Locations: 1 country
• Sites: 5

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.

Conditions

Candidates for BRCA 1/2 Genetic Testing

Outcome Measures

Primary Outcomes (1)

• Number of telephone surveys completed

  3 years

Study Arms (2)

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; 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.

Genetic: Genetic Providers; Other: Visual Aids; Other: Post-Disclosure Asessments; Other: In-person Clinical Follow-Up; Other: 6 Month and 12 Month Assessments

Interventions

Genetic Providers GENETIC

Genetic providers (genetic counselors or nurses) will follow the standardized disclosure protocol for in-person and telephone disclosures whle completing a disclosure flow checklist.

In Person Disclosure; Telephone Disclosure

Visual Aids OTHER

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.

In Person Disclosure; Telephone Disclosure

Post-Disclosure Asessments OTHER

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 Disclosure; Telephone Disclosure

In-person Clinical Follow-Up OTHER

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

In Person Disclosure

6 Month and 12 Month Assessments OTHER

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

In Person Disclosure; Telephone Disclosure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (5)

The John H. Stroger Jr. Hospital of Cook County

Chicago, Illinois, United States

Location

The University of Chicago

Chicago, Illinois, United States

Location

MD Anderson Cancer Center at Cooper

Camden, New Jersey, United States

Location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

The Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Location

Related Publications (2)

• 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.

  PMID: 30417332 DERIVED

• 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.

  PMID: 29490071 DERIVED

MeSH Terms

Interventions

Audiovisual Aids

Intervention Hierarchy (Ancestors)

Educational Technology; Technology; Technology, Industry, and Agriculture

Study Officials

• Angela Bradbury, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2012
• First Posted: November 29, 2012
• Study Start: December 3, 2012
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: July 27, 2022

Record last verified: 2017-07

Locations

US (5)