Evaluation of an Online Prostate Cancer Screening Decision Aid
NCT ID: NCT06610474
Last Updated: 2025-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
510 participants
INTERVENTIONAL
2024-11-27
2026-01-31
Brief Summary
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* 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
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Talk to Nathan
Participants in this arm will use the online "Talk to Nathan about Prostate Cancer Screening" decision aid before their clinic visit.
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
Standard decision aid
Participants in this arm will use a standard decision aid before their clinic visit.
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
Standard education materials
Participants in this arm will use standard education materials before their clinic visit.
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
Interventions
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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
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
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
55 Years
69 Years
MALE
Yes
Sponsors
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ICF Macro, Inc.
OTHER
David Siegel
FED
Responsible Party
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David Siegel
Medical Officer, Division of Cancer Prevention and Control, Principal Investigator
Locations
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East Northport Medical Care
East Northport, New York, United States
Camino
Charlotte, North Carolina, United States
Alliance Medical Ministry
Raleigh, North Carolina, United States
Clemson Rural Health
Clemson, South Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-030
Identifier Type: -
Identifier Source: org_study_id
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