Evaluation of an Online Prostate Cancer Screening Decision Aid

NCT06610474 | Completed

• 1 other identifier: 2023-030
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Prostate Cancer

Keywords

Decision Aid

Outcome Measures

Primary Outcomes (1)

• Measure of changes in decisional conflict

  Assessment by participant survey

  Immediately after clinical encounter with provider

Secondary Outcomes (2)

• Measure of prostate cancer knowledge

  Immediately after clinical encounter with provider

• Measure of autonomous decision-making

  Immediately after clinical encounter with provider

Study Arms (3)

Talk to Nathan

EXPERIMENTAL

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

Standard decision aid

ACTIVE COMPARATOR

Participants in this arm will use a standard decision aid before their clinic visit.

Behavioral: Use of a standard prostate cancer screening decision aid

Standard education materials

ACTIVE COMPARATOR

Participants in this arm will use standard education materials before their clinic visit.

Behavioral: Use of standard prostate cancer education materials

Interventions

Use of the online "Talk to Nathan about Prostate Cancer" decision aid BEHAVIORAL

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

Talk to Nathan

Use of a standard prostate cancer screening decision aid BEHAVIORAL

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

Standard decision aid

Use of standard prostate cancer education materials BEHAVIORAL

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

Standard education materials

Eligibility Criteria

• Age: 55 Years - 69 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• David Siegel: lead
• ICF Macro, Inc.: collaborator

Study Sites (4)

East Northport Medical Care

East Northport, New York, 11731, United States

Location

Camino

Charlotte, North Carolina, 28262, United States

Location

Alliance Medical Ministry

Raleigh, North Carolina, 27610, United States

Location

Clemson Rural Health

Clemson, South Carolina, 29634, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Officer, Division of Cancer Prevention and Control, Principal Investigator

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 24, 2024
• Study Start: November 27, 2024
• Primary Completion: March 30, 2026
• Study Completion: March 30, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (4)