Evaluation of an Online Prostate Cancer Screening Decision Aid

The goal of this clinical trial is to learn if the online, simulated human "Talk to Nathan About Prostate Cancer Screening" decision aid (https://www.cdc.gov/prostate-cancer/talk-to-nathan/index.html) is effective in helping patients decide about prostate cancer screening. The main questions it aims to answer are:

• Is using the "Talk to Nathan About Prostate Cancer Screening" decision aid effective in improving knowledge, overcoming health literacy barriers, and resolving decisional conflict compared to a standard decision aid or standard education materials?
• What are the barriers and best practices for incorporating Talk to Nathan About Prostate Cancer Screening into the flow of primary care practice?

Researchers will compare "Talk to Nathan About Prostate Cancer Screening" to a standard decision aid and to standard prostate cancer screening education materials to test the effectiveness of using "Talk to Nathan About Prostate Cancer Screening."

Participants will:

• Use "Talk to Nathan About Prostate Cancer Screening," use a standard decision aid, or use standard education materials about prostate cancer screening
• Visit the primary care clinic for follow-up
• Complete surveys as part of the clinical trial

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Behavioral: Use of the online "Talk to Nathan about Prostate Cancer" decision aid; Behavioral: Use of a standard prostate cancer screening decision aid; Behavioral: Use of standard prostate cancer education materials

Detailed Description

Goal of the project: To conduct a randomized controlled trial (RCT) to determine if CDC's online, simulated, human decision aid module, Talk to Nathan About Prostate Cancer Screening (treatment arm), is effective in improving knowledge, overcoming health literacy barriers, and resolving decisional conflict compared to a standard decision aid (control arm 1) and standard education materials (control arm 2). Also, to identify barriers and best practices for incorporating Talk to Nathan About Prostate Cancer Screening into the flow of primary care practice.

Intended use of the resulting data: To measure evaluation outcomes, understand how to help men make decisions about the harms and benefits of prostate cancer screening that are in line with the patient's individual values and preferences, and make recommendations for improving the Talk to Nathan About Prostate Cancer Screening decision aid and incorporating it into primary care practice.

Methods to be used to collect: The RCT is a three-group parallel design with one treatment arm and two control arms. Data will be collected from all arms using a pre-exposure survey, a post-exposure survey, and a post-clinic visit survey. The treatment arm will also complete a usability survey and a subset of the treatment arm will be invited to participate in user experience interviews. Health care providers at the four participating clinics will complete a short survey prior to executing the three-arm study and interviews will be conducted at the close of the study with study coordinators from the four participating clinics.

The subpopulation to be studied: For the pre- and post-surveys, the usability survey, and the user experience interviews, the subpopulation is men aged 55-69 years. For the provider survey, the subpopulation is primary care providers who practice within the four clinics participating in the study. For the clinic coordinator interviews, the subpopulation is the study coordinators from the four participating clinics.

How data will be analyzed: For quantitative survey data: intention-to-treat analysis; repeated measures analysis of variance across assessment time points; ordinary least squares regression; complier-average causal effect (CACE) approach to calculate treatment effect; maximum likelihood and Bayesian inferential methods for CACE. For qualitative data from the surveys and interviews: We will identify and analyze themes, patterns, and inter-relationships relevant to the evaluation questions for this study.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • East Northport, New York, United States, 11731
      • East Northport Medical Care
  • North Carolina
    • Charlotte, North Carolina, United States, 28262
      • Camino
    • Raleigh, North Carolina, United States, 27610
      • Alliance Medical Ministry
  • South Carolina
    • Clemson, South Carolina, United States, 29634
      • Clemson Rural Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male.
• Aged 55-69 years.
• Scheduled for an upcoming health exam.
• Has access to the internet.
• Has a valid email address or valid mobile phone number with SMS capabilities.
• Speaks and reads English or Spanish.

Exclusion Criteria:

• Refuses to participate.
• Currently has urinary tract symptoms (i.e., difficulty starting urination; weak or interrupted flow of urine; urinating often, especially at night; trouble emptying the bladder completely; pain or burning during urination; blood in the urine or semen; pain in the back, hips, or pelvis that doesn't go away; or painful ejaculation).
• Prior history of prostate cancer.
• Scheduled for, undergoing, or has had a prostate biopsy.
• A previous PSA score is contained in the patient's health record and it is greater than or equal to 4 ng/mL and/or a very suspicious digital rectal exam (DRE) result (defined as the presence of significant induration, nodularity, or asymmetry).
• Patient has a terminal illness, significant psychiatric comorbidity (identified by clinic coordinator), cognitive deficits, or reports of ongoing substance misuse.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Talk to Nathan; Participants in this arm will use the online "Talk to Nathan about Prostate Cancer Screening" decision aid before their clinic visit.	Behavioral: Use of the online "Talk to Nathan about Prostate Cancer" decision aid; This decision aid is publicly available at this website in both English or Spanish: https://www.cdc.gov/prostate-cancer/talk-to-nathan/index.html
Active Comparator: Standard decision aid; Participants in this arm will use a standard decision aid before their clinic visit.	Behavioral: Use of a standard prostate cancer screening decision aid; The standard decision aid is available here and will be used in either English or Spanish: https://massclearinghouse.ehs.state.ma.us/PROG-CANC/CA1382kit.html
Active Comparator: Standard education materials; Participants in this arm will use standard education materials before their clinic visit.	Behavioral: Use of standard prostate cancer education materials; The standard education materials are available from the National Cancer Institute (NCI) website in English or Spanish: https://www.cancer.gov/types/prostate/patient/prostate-screening-pdq

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of changes in decisional conflict	Assessment by participant survey	Immediately after clinical encounter with provider

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of prostate cancer knowledge	Assessment by participant survey	Immediately after clinical encounter with provider
Measure of autonomous decision-making	Assessment by participant survey	Immediately after clinical encounter with provider

Collaborators and Investigators

• Sponsor: David Siegel
• Collaborators: ICF Macro, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2024
• Primary Completion (Actual): March 30, 2026
• Study Completion (Actual): March 30, 2026

Study Registration Dates

• First Submitted: September 20, 2024
• First Submitted That Met QC Criteria: September 20, 2024
• First Posted (Actual): September 24, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Decision Aid
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 2023-030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In development.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No