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Trial record 32 of 121 for:    prostate cancer AND prostate cancer screening | ( Map: United States )

Trial of Community Health Worker-led Decision Coaching

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03726320
Recruitment Status : Not yet recruiting
First Posted : October 31, 2018
Last Update Posted : January 21, 2019
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
Black men are disproportionately affected by prostate cancer, the most common non-cutaneous malignancy among men in the U.S. This randomized trial will evaluate the efficacy of a Community Health Worker-led decision coaching program to facilitate Shared Decision Making (SDM) and Prostate Specific Antigen (PSA) screening among Black men with regards to decision quality, the decision making process, patient-provider communication and PSA utilization for Black men in the primary care setting.

Condition or disease Intervention/treatment Phase
Prostate Cancer Behavioral: Education Counseling Session for PSA Screening Behavioral: General Health Counseling Coaching Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 228 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Screening
Official Title: Randomized Trial of Community Health Worker-led Decision Coaching to Promote Shared Decision Making for Prostate Cancer Screening Among Black Male Patients and Their Providers
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Intervention Group
a decision aid along with decision coaching on PSA screening from a Community Health Worker (CHW)
Behavioral: Education Counseling Session for PSA Screening
counseling from extensively trained CHW

Active Comparator: Control Group
a decision aid along with CHW interaction on dietary and lifestyle modification to serve as an attention control.
Behavioral: General Health Counseling Coaching
coaching using an educational tool focused on dietary and lifestyle modification




Primary Outcome Measures :
  1. Decision Self-Efficacy Scale [ Time Frame: 9 Months ]
    11 item scale measuring self-efficacy to perform informed decision making (e.g. getting needed information, asking questions, expressing opinions, and asking for advice)

  2. Prostate Specific Antigen (PSA) screening Rates [ Time Frame: 5 Years ]
    PSA rates collected through patient self-reported PSA testing and EHR data on PSA test utilization



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Gender Identity
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Patients:

  • Black
  • Male
  • Attending FQHC for routine primary care appointment

Providers:

  • Provider at Sunset Park Health Council Federally Qualified Health Center (FQHC)
  • Caring for patients that fit inclusion criteria

Exclusion Criteria:

  • Provider at Sunset Park Health Council Federally Qualified Health Center (FQHC)
  • Caring for patients that fit inclusion criteria

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): NCT03726320


Contacts
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Contact: Shannon Ciprut 646 501 2938 shannon.ciprut@nyumc.org
Contact: Matthew Kelly 646 501 2938 Matthew.Kelly@nyumc.org

Locations
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United States, New York
New York University School of Medicine Not yet recruiting
New York, New York, United States, 10016
Contact: Shannon Ciprut    646-501-2938    shannon.ciprut@nyumc.org   
Principal Investigator: Danil Makarov, MD         
Sponsors and Collaborators
NYU Langone Health
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
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Principal Investigator: Danil Makarov, MD NYU Langone Health

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03726320     History of Changes
Other Study ID Numbers: 18-00514
1R01MD012243-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: January 21, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Aggregate participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
Supporting Materials: Study Protocol
Time Frame: Immediately following publication. No end date.
Access Criteria: Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting requests and accessing data may be found at (Link to be provided).Researchers who provide a methodologically sound proposal will have access to the data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases