AzTrials
AzTrials

Prostate CancerNCT03726320

Trial of Community Health Worker-led Decision Coaching

A study testing Education Counseling Session for PSA Screening and General Health Counseling Coaching in people with Prostate Cancer, run by NYU Langone Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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)… Read more about this study

Who is it for?
Ages 40 to 69 years, men onlyHealthy volunteers can take part
Conditions the study is for
Prostate Cancer
What is being tested?
Education Counseling Session for PSA Screening and General Health Counseling Coaching
Could I receive a placebo?
No, everyone receives an active treatment
How many people
162 participants
Where
1 siteUnited States
Study dates
15 Oct 2019to 20 Sep 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 69 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • New York University School of Medicine

    New York, New York, 10016

Other trials in United States

About this study

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

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.

Conditions
Prostate Cancer
Being tested
Education Counseling Session for PSA Screening, General Health Counseling Coaching
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Education Counseling Session for PSA ScreeningBehavioural

    counseling from extensively trained CHW

  • General Health Counseling CoachingBehavioural

    coaching using an educational tool focused on dietary and lifestyle modification

Study groups in NCT03726320
Study groupRoleWhat they receive
Intervention GroupExperimentalA decision aid along with decision coaching on PSA screening from a Community Health Worker (CHW). The intervention will be administered directly prior to the participant's appointment with their provider.
Receives: Behavioral: Education Counseling Session for PSA Screening
Control GroupActive comparatorA decision aid along with CHW interaction on dietary and lifestyle modification to serve as an attention control. The intervention will be administered directly prior to the participant's appointment with their provider.
Receives: Behavioral: General Health Counseling Coaching

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prostate Specific Antigen (PSA) Screening Rates

    Percentage of participants who receive at least one PSA screening. Screening data are collected through patient self-reports and electronic health record data.

    Measured: Up to Month 3

  2. Patient Knowledge Survey Score

    The Patient Knowledge Survey comprises 12 items assessing participants' understanding of PSA testing and prostate cancer. Respondents provide an answer of "True," "Unsure," or "False." The total score is the sum of correct responses and ranges from 0-12; higher scores indicate greater knowledge.

    Measured: Day 1

  3. Decision Quality Score

    Scale consists of 12 items assessing participants' attitudes toward prostate cancer treatment and screening (6 Pros and 6 Cons of testing) scored on a 5 point Likert scale (Strongly Disagree to Strongly Agree). The total score is the sum of responses and ranges from -24 to +24; Positive scores indicate a more favorable assessment of the pros versus the cons of the test.This survey will be administered twice: once directly following the coaching session prior to the patient's appointment, and again following the appointment.

    Measured: Day 1

  4. Percentage of Participants Who Make Informed Choice

    Percentage of participants who made an Informed Choice to either undergo or decline PSA testing. Informed choices are those in which:

    1. Men with good knowledge and positive measure of informed choice attitudes (> or = 22) choose to undergo the test OR 2) Men with good knowledge but negative measure of informed choice attitudes (<22) towards the test, do not undergo the test The Measure of Informed Choice Attitudes survey is administered twice: once directly following the coaching session prior to the patient's appointment, and again following the appointment and the patient's screening decision is recorded during post-appointment.

    Measured: Day 1

Secondary outcomes (6)

  1. Decision Self-Efficacy Scale Score

    The Decision Self-Efficacy Scale is an 11-item survey measuring confidence in making an informed choice. Each item is rated on a scale from 0-4, where 0 = not at all confident and 4 = very confident. The raw score is the sum of responses and is transformed to a standard total score ranging from 0 to 100; higher scores indicate "extremely high self-efficacy."

    Measured: Day 1

  2. Doctor-Patient Communication Survey Score

    The Doctor-Patient Communication Survey includes 19 items assessing how participants felt they were able to communicate with their provider. Each item is rated on a scale from 1-5, where 1 = strongly disagree and 5 = strongly agree. The total score is the average score of responses and ranges from 0 to 5; higher scores indicate greater doctor-patient communication.

    Measured: Day 1

  3. Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI) Score

    PEPPI is a 10-item assessment of participant's perceived self-efficacy for communicating with their provider. Each item is rated on a scale from 1-5, where 1 = not at all confident and 5 = very confident. The total score is the sum of responses and ranges from 10 to 50; higher scores indicate greater self-efficacy in communicating with providers.

    Measured: Day 1

  4. Change in Decisional Conflict Scale Score

    The Decisional Conflict Scale is a 16-item survey assessing the level of decisional conflict for participants when deciding whether to have prostate cancer screening. Each item is rated on a 0-4 scale, where 0 = strongly agree and 4 = strongly disagree. The total score is the sum of responses and ranges from 0 to 64. Scores lower than 25 are associated with implementing decisions; scores exceeding 37.5 are associated with decision delay or feeling unsure about implementation.

    Measured: Day 1

  5. Satisfaction With Decision Scale Score

    6-item assessment of participants' satisfaction with their prostate cancer screening decisions. Each item is rated on a 1-5 scale, where 1 = strongly disagree and 5 = strongly agree. The total score is the average of all items and ranges from 1-5. Higher scores indicate greater satisfaction with decision.

    Measured: Day 1

  6. Decisional Regret Scale Survey

    5-item assessment of participants' regret toward the first decision they made about prostate cancer screening after speaking with their provider. Each item is rated on a scale from 1-5, where 1 = strongly agree and 5 = strongly disagree. The total score is the sum of responses and ranges from 5 to 25. Higher scores indicate greater regret. To help others interpret the score more readily with other scales ranging from 0 to 100, these scores can then be converted to a 0-100 scale by subtracting 1 from each item then multiply by 25. To obtain a final score, the items are summed and averaged. The final score presented ranges from 0 to 100, higher scores indicate greater regret.

    Measured: Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2018
  2. Study start15 Oct 2019
  3. Primary completion21 Apr 2023
  4. Study completion20 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Investigator
Enrolment
162 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03726320
Sponsor's protocol ID
18-00514
Other IDs
1R01MD012243-01A1
Status last verified
May 2024
First submitted
7 Sep 2018
Last updated
23 May 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Aggregate participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

Publications

  • Makarov DV, Feuer Z, Ciprut S, Lopez NM, Fagerlin A, Shedlin M, Gold HT, Li H, Lynch G, Warren R, Ubel P, Ravenell JE. 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. Trials. 2021 Feb 10;22(1):128. doi: 10.1186/s13063-021-05064-4.

    PubMed 33568208

Questions about this trial

What is this clinical trial studying?

A study testing Education Counseling Session for PSA Screening and General Health Counseling Coaching in people with Prostate Cancer, run by NYU Langone Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prostate Specific Antigen (PSA) Screening Rates (time frame: Up to Month 3). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03726320, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in