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Comparison of 3 Modes of Genetic Counseling in High-Risk Public Hospital Patients (GC3Modes)

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ClinicalTrials.gov Identifier: NCT03006913
Recruitment Status : Recruiting
First Posted : December 30, 2016
Last Update Posted : January 28, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
University of California, Davis
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Rena J. Pasick, DrPH, University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Genetic Counseling Behavioral: In-person Behavioral: By phone Behavioral: By video Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparison of 3 Modes of Genetic Counseling in High-Risk Public Hospital
Actual Study Start Date : April 18, 2017
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Randomization to counseling: In-person
Behavioral: Comparing genetic counseling modes.
Behavioral: In-person
At all sites, patients randomized to/preferring in-person counseling will meet with a counselor.

Active Comparator: Randomization to counseling: By phone
Behavioral: Comparing genetic counseling modes.
Behavioral: By phone
Patients in the phone arm will receive a scheduled call at their home.

Active Comparator: Randomization to counseling: By video
Behavioral: Comparing genetic counseling modes.
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.




Primary Outcome Measures :
  1. Differences in change scores among three counseling modes: Breast Cancer Knowledge Scale [ Time Frame: One week post counseling ]
    Will measure knowledge of hereditary breast cancer information before and after delivery of counseling modes.

  2. Differences in change scores among three counseling modes: Impact of Events Scale [ Time Frame: One week post counseling ]
    Will measure cancer-specific distress before and after delivery of counseling modes.


Secondary Outcome Measures :
  1. Differences in change scores among three counseling modes: Decisional Conflict Scale [ Time Frame: One week post counseling ]
    Will measure decisional conflict before and after implementation of counseling modes.

  2. Differences in change scores among three counseling modes: Perceived Stress Scale [ Time Frame: One week post counseling ]
    Will measure general perceptions of stress before and after implementation of counseling modes.

  3. Differences in change scores among three counseling modes: Breast/Ovarian Cancer Risk Perception and Worry Scale [ Time Frame: One week post counseling ]
    Will measure breast cancer and ovarian cancer risk perception and worry before and after implementation of counseling modes.

  4. Differences in change scores among three counseling modes: Perceptions of Risks and Benefits of Genetic Counseling Scale [ Time Frame: One week post counseling ]
    Will measure perceptions of risks and benefits of genetic counseling before and after implementation of counseling modes.

  5. Differences in change scores among three counseling modes: Genetic Counseling Satisfaction Scale [ Time Frame: One week post counseling ]
    Will measure genetic counseling satisfaction before and after implementation of counseling modes.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:Eligible participants include patients who

  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03006913


Contacts
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Contact: Rena J. Pasick, DrPH 415.514.9415 Rena.pasick@ucsf.edu
Contact: Claudia S Guerra, MSW 415.514.9411 claudia.guerra@ucsf.edu

Locations
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United States, California
Contra Costa Regional Medical Center Health Services Recruiting
Martinez, California, United States, 94553
Contact: Lili Wang, MD    925-370-5110    Lili.Wang@hsd.cccounty.us   
Contact: Heather Cedermaz, MSN, FNP-C    510-381-9673    Heather.Cedermaz@hsd.cccounty.us   
Principal Investigator: Lili Wang Wang, MD         
Highland General Hospital Recruiting
Oakland, California, United States, 94602
Contact: Richard Godfrey, MD    510-918-2312    richgodfrey77@gmail.com   
Contact: Jin Kim, MS    510.567.5784    jikim@alamedahealthsystem.org   
Principal Investigator: Richard Godfrey, MD         
San Francisco General Hospital Not yet recruiting
San Francisco, California, United States, 94110
Contact: Niharika Dixit, MD    415-476-4082 ext 134    Niharika.Dixit@ucsf.edu   
Contact: Robin Lee, MS, LCGC    (415) 885-3712    Robin.Lee2@ucsf.edu   
Principal Investigator: Niharika Dixit, MD         
Sponsors and Collaborators
University of California, San Francisco
National Institutes of Health (NIH)
University of California, Davis
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Rena J. Pasick, DrPH University of California, San Francisco
Principal Investigator: Galen Joseph, PhD Universidad de California, San Francisco
Study Director: Claudia S Guerra, MSW University of California, San Francisco

Publications:

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Responsible Party: Rena J. Pasick, DrPH, Professor, Medicine & Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03006913     History of Changes
Other Study ID Numbers: UCSF-GC3-2021
R01CA197784-01A1 ( U.S. NIH Grant/Contract )
First Posted: December 30, 2016    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rena J. Pasick, DrPH, University of California, San Francisco:
Genetic counseling modes