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

NCT03006913 | Completed

• 2 other identifiers: UCSF-GC3-2021R01CA197784-01A1
• Study Type: interventional
• Target: 1,273
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Genetic counseling modes

Outcome Measures

Primary Outcomes (2)

• Differences in change scores among three counseling modes: Breast Cancer Knowledge Scale

  Will measure knowledge of hereditary breast cancer information before and after delivery of counseling modes.

  One week post counseling

• Differences in change scores among three counseling modes: Impact of Events Scale

  Will measure cancer-specific distress before and after delivery of counseling modes.

  One week post counseling

Secondary Outcomes (5)

• Differences in change scores among three counseling modes: Decisional Conflict Scale

  One week post counseling

• Differences in change scores among three counseling modes: Perceived Stress Scale

  One week post counseling

• Differences in change scores among three counseling modes: Breast/Ovarian Cancer Risk Perception and Worry Scale

  One week post counseling

• Differences in change scores among three counseling modes: Perceptions of Risks and Benefits of Genetic Counseling Scale

  One week post counseling

• Differences in change scores among three counseling modes: Genetic Counseling Satisfaction Scale

  One week post counseling

Study Arms (3)

Randomization to counseling: In-person

ACTIVE COMPARATOR

Behavioral: Comparing genetic counseling modes.

Behavioral: In-person

Randomization to counseling: By phone

ACTIVE COMPARATOR

Behavioral: Comparing genetic counseling modes.

Behavioral: By phone

Randomization to counseling: By video

ACTIVE COMPARATOR

Behavioral: Comparing genetic counseling modes.

Behavioral: By video

Interventions

In-person BEHAVIORAL

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

Randomization to counseling: In-person

By phone BEHAVIORAL

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

Randomization to counseling: By phone

By video BEHAVIORAL

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.

Randomization to counseling: By video

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• visit the mammography, high risk or oncology clinics at Contra Costa County, Highland or SFGH hospitals,
• are referred to genetic counseling services at SFGH by a community clinic through the E-Referral system or are considered to be high risk based on their breast/ovarian cancer genetics Referral Screening Tool (RST) score (≥ 2 checks)
• speak English, Spanish, or Cantonese
• Investigators will also include two genetic counselors who provide services at SFGH and UCSF.

You may not qualify if:

• do not speak English, Spanish, or Cantonese;
• are age 17 and under; and
• don't have a family history of cancer.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institutes of Health (NIH): collaborator
• University of California, Davis: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Contra Costa Regional Medical Center Health Services

Martinez, California, 94553, United States

Location

Highland General Hospital

Oakland, California, 94602, United States

Location

San Francisco General Hospital

San Francisco, California, 94110, United States

Location

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Study Officials

• Rena J. Pasick, DrPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Galen Joseph, PhD

  Universidad de California, San Francisco

  PRINCIPAL INVESTIGATOR

• Claudia S Guerra, MSW

  University of California, San Francisco

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2016
• First Posted: December 30, 2016
• Study Start: April 18, 2017
• Primary Completion: December 16, 2019
• Study Completion: December 16, 2019
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)