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Trial record 32 of 123 for:    prostate cancer AND prostate cancer screening | ( Map: United States )

Trial of Community Health Worker-led Decision Coaching

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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

Tracking Information
First Submitted Date  ICMJE September 7, 2018
First Posted Date  ICMJE October 31, 2018
Last Update Posted Date January 21, 2019
Estimated Study Start Date  ICMJE March 1, 2019
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2018)
  • 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)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03726320 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Community Health Worker-led Decision Coaching
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Screening
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Behavioral: Education Counseling Session for PSA Screening
    counseling from extensively trained CHW
  • Behavioral: General Health Counseling Coaching
    coaching using an educational tool focused on dietary and lifestyle modification
Study Arms  ICMJE
  • Experimental: Intervention Group
    a decision aid along with decision coaching on PSA screening from a Community Health Worker (CHW)
    Intervention: Behavioral: Education Counseling Session for PSA Screening
  • Active Comparator: Control Group
    a decision aid along with CHW interaction on dietary and lifestyle modification to serve as an attention control.
    Intervention: Behavioral: General Health Counseling Coaching
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 29, 2018)
228
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2020
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: Gender Identity
Ages  ICMJE 40 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Shannon Ciprut 646 501 2938 shannon.ciprut@nyumc.org
Contact: Matthew Kelly 646 501 2938 Matthew.Kelly@nyumc.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03726320
Other Study ID Numbers  ICMJE 18-00514
1R01MD012243-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Responsible Party NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE National Institute on Minority Health and Health Disparities (NIMHD)
Investigators  ICMJE
Principal Investigator: Danil Makarov, MD NYU Langone Health
PRS Account NYU Langone Health
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP