Comparison of 3 Modes of Genetic Counseling in High-Risk Public Hospital Patients

Summary

Using mixed methods, investigators will conduct a multicenter partially randomized preference noninferiority trial with high-risk English-, Spanish-, and Cantonese-speaking patients assigned by (1) patients´ preference or (2) randomization to three counseling modes: (a) in-person; (b) phone; or (c) video conference. A total of 600 patients will complete counseling and 540 will complete the final survey. Baseline and post-counseling surveys will use validated measures (adapted for literacy and language) of study outcomes. All counseling sessions will be audio-taped. A sample of 90 tapes will be analyzed for counseling content and to identify 30 participants for in-depth interviews and analysis triangulating all forms of data. Genetic counselors will be interviewed in depth to elicit their perceptions of the strengths and limitations of each counseling mode.

Conditions

• Genetic Counseling

Interventions

BEHAVIORAL

In-person

At all sites, patients randomized to/preferring in-person counseling will meet with a counselor.

BEHAVIORAL

By phone

Patients in the phone arm will receive a scheduled call at their home.

BEHAVIORAL

By video

Because low income patients are not likely to have video conference capability at home, this service will be offered at all three hospitals, and patients will have scheduled appointments to come to the hospital to receive counseling delivered through a computer.

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• University of California, Davis

  collaborator OTHER

• National Cancer Institute (NCI)

  collaborator NIH

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Rena J. Pasick, DrPH · University of California, San Francisco

• Galen Joseph, PhD · Universidad de California, San Francisco

• Claudia S Guerra, MSW · University of California, San Francisco

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-04-18

Primary Completion

2019-12-16

Completion

2019-12-16

Countries

• United States

Study Locations