Prostate CancerNCT06610474
Evaluation of an Online Prostate Cancer Screening Decision Aid
A study testing Use of the online "Talk to Nathan about Prostate Cancer" decision aid, Use of a standard prostate cancer screening decision aid and Use of standard prostate cancer education materials in people with Prostate Cancer, run by David Siegel at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 69 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Use of the online "Talk to Nathan about Prostate Cancer" decision aid, Use of a standard prostate cancer screening decision aid and Use of standard prostate cancer education materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 4 sitesUnited States
- Study dates
- 27 Nov 2024to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 55 to 69 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Camino
Charlotte, North Carolina, 28262
Clemson Rural Health
Clemson, South Carolina, 29634
East Northport Medical Care
East Northport, New York, 11731
Alliance Medical Ministry
Raleigh, North Carolina, 27610
About this study
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?
Read more
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
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Use of the online "Talk to Nathan about Prostate Cancer" decision aid, Use of a standard prostate cancer screening decision aid, Use of standard prostate cancer education materials
- Keywords
- Decision Aid
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of the online "Talk to Nathan about Prostate Cancer" decision aidBehavioural
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 aidBehavioural
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 materialsBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Use of standard prostate cancer education materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of changes in decisional conflict
Assessment by participant survey
Measured: Immediately after clinical encounter with provider
Secondary outcomes (2)
Measure of prostate cancer knowledge
Assessment by participant survey
Measured: Immediately after clinical encounter with provider
Measure of autonomous decision-making
Assessment by participant survey
Measured: Immediately after clinical encounter with provider
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start27 Nov 2024
- Primary completion30 Mar 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Siegel
- Sponsor type
- US federal agency
- Collaborators
- ICF Macro, Inc.
- Responsible party
- Sponsor-investigator, David Siegel, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06610474
- Sponsor's protocol ID
- 2023-030
- Status last verified
- Apr 2026
- First submitted
- 20 Sep 2024
- Last updated
- 17 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In development.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Online Prostate Cancer Screening Decision Aid
- ClinicalTrials.gov ID
- NCT06610474
- Acronym / sponsor ID
- 2023-030
- Conditions
- Prostate Cancer
- Keywords
- Decision Aid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- David SiegelUS federal agency
- Collaborators
- ICF Macro, Inc.
- Study start
- 27 Nov 2024 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Talk to Nathan | Experimental | Behavioral: Use of the online "Talk to Nathan about Prostate Cancer" decision aidParticipants in this arm will use the online "Talk to Nathan about Prostate Cancer Screening" decision aid before their clinic visit. |
| Standard decision aid | Active comparator | Behavioral: Use of a standard prostate cancer screening decision aidParticipants in this arm will use a standard decision aid before their clinic visit. |
| Standard education materials | Active comparator | Behavioral: Use of standard prostate cancer education materialsParticipants in this arm will use standard education materials before their clinic visit. |
Who may qualify
- Ages
- 55 to 69 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of the online "Talk to Nathan about Prostate Cancer" decision aidThis decision aid is publicly available at this website in both English or Spanish: https://www.cdc.gov/prostate-cancer/talk-to-nathan/index.html | Behavioural | Talk to Nathan |
| Use of a standard prostate cancer screening decision aidThe 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 | Behavioural | Standard decision aid |
| Use of standard prostate cancer education materialsThe 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 | Behavioural | Standard education materials |
Primary outcome
Measure of changes in decisional conflict
Time frame: Immediately after clinical encounter with provider
Assessment by participant survey
2 secondary outcomes
Measure of prostate cancer knowledge
Time frame: Immediately after clinical encounter with provider
Measure of autonomous decision-making
Time frame: Immediately after clinical encounter with provider
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: Yes. In development.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of the online "Talk to Nathan about Prostate Cancer" decision aid, Use of a standard prostate cancer screening decision aid and Use of standard prostate cancer education materials in people with Prostate Cancer, run by David Siegel at 4 sites 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 6 inclusion and 6 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 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measure of changes in decisional conflict (time frame: Immediately after clinical encounter with provider). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2026.