Prostate CancerNCT06549036
Veteran Peer Navigators to Promote Shared Decision Making for PSA Screening
A study testing Veteran Peer Decision Coaching Session for PSA Screening in people with Prostate Cancer, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The project will investigate the efficacy of a Veteran-peer-navigator-led decision coaching (PDC) program to promote Shared Decision Making (SDM) for prostate cancer screening among Veterans at the Veterans Health Administration (VA). 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?
- Veteran Peer Decision Coaching Session for PSA Screening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2027to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Veteran patient participants:
- Veteran
- Male
- Attending VANYHHS-Manhattan for routine primary care appointment
- Providers:
- Primary care provider at VA New York Harbor Healthcare System (VANYHHS)
- Caring for patients that fit inclusion criteria
Who cannot join
- Veteran Patients:
- Patients seen within 9 months of other prostate-specific antigen (PSA) tests
- Patients seen within 180 days after primary diagnosis of urinary obstruction, prostatitis, hematuria, other disorder of prostate, unexplained weight loss, or lumbar back pain
- Patients with a prior diagnosis of prostate cancer (ICD-10-CM C61)
- Patients visiting their provider for any indication other than a well-visit appointment
- Providers:
- Providers who do not treat adult male patients (e.g. OB/Gyns, pediatricians)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
VA NY Harbor Healthcare System, New York, NY
New York, New York, 10010-5011
Jerry K Thomas, MPH BA, (201) 316-3440, Jerry.Thomas3@va.gov
Danil V Makarov, MD MHS
About this study
Official title: Randomized Trial of Veteran Peer Navigators to Promote Shared Decision Making for PSA Screening
The project will investigate the efficacy of a Veteran-peer-navigator-led decision coaching (PDC) program to promote Shared Decision Making (SDM) for prostate cancer screening among Veterans at the Veterans Health Administration (VA). Prostate cancer is commonly screen detected using PSA, a non-specific test which has led to modest population-level survival benefits at the cost of over-detection of low-risk disease. This trade off in outcomes is ideally addressed using SDM which can be challenging to implement in time constrained primary care office visits. The investigators propose the evaluation of a PDC intervention to promote SDM for PSA screening to improve both access and quality of care for Veterans. The investigators results will enhance understanding of the efficacy, cost-effectiveness, and sustainability of PDC interventions for SDM promotion across communication formats in the VA. Lessons learned through this proposal will not only improve quality of care for PSA screening but also will suggest a paradigm for dissemination of SDM across preventive services.
Read the detailed description
Prostate cancer is the most common non-cutaneous malignancy among men in the United States, accounting for one third of new cancer diagnoses in VA. Prostate Cancer is commonly detected using prostate-specific antigen (PSA), a non-specific test whose use in prostate cancer screening has led to modest population-level survival benefits at the cost of over-detection of low-risk disease. Recognizing this trade off, United States Preventive Services Task Force (USPSTF) and VHA Clinical Preventive Services recommend a Shared Decision Making (SDM) approach to PSA screening. Regardless of whether they ultimately elect PSA screening or not, patients should discuss the best evidence for and against it with clinicians and be supported to make high quality decisions. In spite of broad support for these recommendations, SDM is challenging to implement because primary care providers see it as too time consuming and have insufficient training and support to perform it. Moreover, primary care office visits are notoriously too brief to address the multitude of recommended, beneficial preventive interventions. There is an urgent need to incorporate SDM paradigms into routine VA clinical practice. An ideal intervention accomplishing this would improve decision quality at low cost and be acceptable to Veterans and clinicians.
The primary challenge to implementing routine PSA SDM counseling is clinic workflow. One solution may be to enlist non-clinician healthcare team members to offer SDM counseling. Decision coaches can provide non-directive support to help patients weigh options, prepare for provider discussions, and implement decisions. Decision coaches improve knowledge and promote SDM. In a pilot program, the investigators group trained lay health workers as decision coaches to counsel Black men considering PSA screening in a non-VA community care setting. There is an urgent need to expand this approach to all men considering PSA screening and adapt it to the VA setting. The investigators propose training Veteran peers, who are well-known to promote healthful behaviors among Veterans, to be decision coaches to promote SDM among Veterans considering PSA screening. This peer-led approach may provide excellent counseling at acceptable cost and decreased clinician burden.
The objective of this study is to test the efficacy of a Veteran-peer-navigator-led decision-coaching program (PDC) to facilitate SDM for PSA screening at VA NY Harbor. The investigators will randomize Veterans seeking primary care to receive 1) a standard of care screening decision aid (DA) along with PDC on PSA screening (intervention), or 2) the same DA without counseling (control). The outcomes of interest are decision quality, PSA utilization, acceptability and cost of the PDC program with the goal of future system-wide dissemination. Additionally, since VA is dedicated to promoting health equity through telehealth, the investigators will explore the effects of patient race (Black versus non-Black) and communication format (in-person versus telehealth).
- Conditions
- Prostate Cancer
- Being tested
- Veteran Peer Decision Coaching Session for PSA Screening
- Keywords
- prostate cancer, Prostate-Specific Antigen, shared decision making
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Veteran Peer Decision Coaching Session for PSA ScreeningBehavioural
Also called PDC Intervention
Veterans in the intervention arm will review the content of the mailed DA, including the values clarification exercise, with the Veteran PDC. Veteran PDC Counseling includes: 1) a structured interview with the patient that focuses on determining his understanding of his prostate cancer risk, his screening options, and his goals and values related to his decision making and 2) role playing exercises to improve SDM skills.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Veterans randomized to the intervention arm will receive a decision aid in the mail along with decision coaching on PSA screening from a Veteran Veteran-peer-navigator decision coach. The intervention will be administered prior to the Veteran patient's appointment with the provider. |
| Control Group | No intervention | Veteran patients in the control arm will receive a decision aid alone in the mail without any additional counseling prior to their office visit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional Conflict
The 16-item Decisional Conflict Scale (DCS) measures Veterans' perceptions of 1) uncertainty in choosing options, 2) feelings of having adequate knowledge and clear values, and 3) effective decision making. DCS is scored on a 5-point Likert scales with scores ranging from 0 (no decisional conflict) to 100 (extremely high decisional conflict)
Measured: Up to 3 months
Patient Knowledge Survey Score
The Patient Knowledge Survey comprises of 12-items assessing prostate cancer and PSA screening knowledge. Respondents provide an answer of "True", "Unsure", or "False". The total score is the sum of correct responses and ranges from 0 - 12 with higher scores indicating greater knowledge levels.
Measured: Day 1
Decision Quality Score
Decision quality will be measured through 3 domains: 1) decisional conflict 2) being informed (e.g. accurate understanding about screening and its risks and benefits) and 3) making preference-concordant decisions (i.e. treatment consistent with patient preferences). The Decision Quality Balance Scale consists of 12 questions (6 Pros and 6 Cons of testing) scored on a 5 point Likert scale (Strongly Disagree to Strongly Agree) that represents the relative strengths of the pros versus the cons and ranges from -24 to +24. A high quality decision is when patients are both well-informed and making preference-concordant decisions (i.e. treatment consistent with patient preferences as determined by responses to survey questions).
Measured: Day 1
Prostate-specific Antigen (PSA) Screening Rates
Percentage of participants who receive at least one PSA screening test. Screening data is collected through patient self-report and electronic health record data.
Measured: Up to Month 3
Percentage of Participants Who Make Informed Choice (Knowledge Survey + Measure of Informed Choice Attitudes Scale)
The percentage of participants who make an informed choice to either undergo or decline PSA testing. Informed choices are those in which:
- 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.
Measured: Day 1
Measure of Informed Choice Attitudes Scale
The measure of Informed Choice evaluates the screening decision. The 4-item measure consists of items assessing knowledge, attitude towards the screening test, and a record of test uptake. The questions are graded on a 7 point Likert-type scale (1 to 7) with scores ranging from 4 to 28. The median of 22 was taken to classify men's attitudes as positive or negative, with scores 22 or above indicating positive attitudes, and those below 22 indicating negative attitudes.
Measured: Day 1
Secondary outcomes (6)
Combined Outcome Measure for Risk communication And treatment Decision making Effectiveness (COMRADE)
Combined Outcome Measure for Risk communication And treatment Decision making Effectiveness (COMRADE) is a 20-item measure validated for clinical encounters with sub-scales in 1) satisfaction with physician communication and 2) patient confidence in the decision. The scale is graded on a 5 point Likert scale (1 to 5) with a range from 1 to 100 maximum. Higher scores indicate higher satisfaction with communication.
Measured: Day 1
Doctor-Patient Communication Survey
The Questionnaire Concerning Doctor-Patient Communication Skills is a validated 19 item scale that captures process (greeting, listening) and content (explanations and next steps) aspects of the visit from the provider's and patient's perspectives. The questions are scored on a 5-point Likert scale (1 Strongly Disagree to 5 Strongly Agree) with Higher scores (4-5) indicating satisfaction with provider communication
Measured: Day 1
Decision Self-Efficacy
The Decision Self-Efficacy Scale is an 11 item scale measuring self-efficacy to perform informed decision making (e.g. getting needed information, asking questions, expressing opinions, and asking for advice). The questions are scored on a 5-point Likert scale (0 Strongly Disagree to 4 Strongly Agree) and range from 0 (not at all confident) to 100 (very confident).
Measured: Day 1
Self-efficacy for Communicating with Provider
Perceived Efficacy in Patient-Physician Interactions is a 10-item scale measuring self-efficacy for communicating with a provider. The questions are scored on a 5-point Likert scale (1 Not at all confident to 5 Very confident) with a range of possible scores from 10 to 50 (highest patient perceived self-efficacy for communicating with provider).
Measured: Day 1
Satisfaction with Decision Scale
The SWD is a 6-item measure assessing patient satisfaction with their decision and the decision making process. The questions are scored on a 5-point Likert scale (1 Strongly Disagree to 5 Strongly Agree). Higher scores indicate higher satisfaction with decision (scores range from 1-5).
Measured: Up to 3 Months
Decisional Regret Scale
The Decisional Regret Scale is a validated, 5-item scale measuring regret or remorse following a health care decision. Questions are scored on a 5-point Likert scale (5 Strongly Disagree to 1 Strongly Agree). Scores range from 0 (means no regret) to 100 (means high regret).
Measured: Up to 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start4 Jan 2027 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Danil V Makarov, MD MHS, Principal investigator, VA NY Harbor Healthcare System, New York, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06549036
- Sponsor's protocol ID
- IIR 22-090
- Other IDs
- 5I01HX003622-02, I01HX003622-01A2
- Status last verified
- Oct 2026
- First submitted
- 8 Aug 2024
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wright Nunes J, Kerr E, Ojo A, Powell C, Fan A, Brinley FJ, Devine A, Ellies T, Grzyb K, Garcia-Guzman L, Nakai T, Oliverio A, Chen E, Fagerlin A. Patient Education for CKD and Decision Support in Primary Care: Findings From the EPIK Pilot Study. Am J Kidney Dis. 2025 Mar;85(3):284-292. doi: 10.1053/j.ajkd.2024.10.005. Epub 2024 Dec 14.
PubMed 39675547
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Veteran Peer Navigators to Promote Shared Decision Making for PSA Screening
- ClinicalTrials.gov ID
- NCT06549036
- Acronym / sponsor ID
- IIR 22-090
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, Prostate-Specific Antigen, shared decision making
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 4 Jan 2027 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 12 Aug 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 project will investigate the efficacy of a Veteran-peer-navigator-led decision coaching (PDC) program to promote Shared Decision Making (SDM) for prostate cancer screening among Veterans at the Veterans Health Administration (VA). Prostate cancer is commonly screen detected using PSA, a non-specific test which has led to modest population-level survival benefits at the cost of over-detection of low-risk disease. This trade off in outcomes is ideally addressed using SDM which can be challenging to implement in time constrained primary care office visits. The investigators propose the evaluation of a PDC intervention to promote SDM for PSA screening to improve both access and quality of care for Veterans. The investigators results will enhance understanding of the efficacy, cost-effectiveness, and sustainability of PDC interventions for SDM promotion across communication formats in the VA. Lessons learned through this proposal will not only improve quality of care for PSA screening but also will suggest a paradigm for dissemination of SDM across preventive services.
Detailed description
Prostate cancer is the most common non-cutaneous malignancy among men in the United States, accounting for one third of new cancer diagnoses in VA. Prostate Cancer is commonly detected using prostate-specific antigen (PSA), a non-specific test whose use in prostate cancer screening has led to modest population-level survival benefits at the cost of over-detection of low-risk disease. Recognizing this trade off, United States Preventive Services Task Force (USPSTF) and VHA Clinical Preventive Services recommend a Shared Decision Making (SDM) approach to PSA screening. Regardless of whether they ultimately elect PSA screening or not, patients should discuss the best evidence for and against it with clinicians and be supported to make high quality decisions. In spite of broad support for these recommendations, SDM is challenging to implement because primary care providers see it as too time consuming and have insufficient training and support to perform it. Moreover, primary care office visits are notoriously too brief to address the multitude of recommended, beneficial preventive interventions. There is an urgent need to incorporate SDM paradigms into routine VA clinical practice. An ideal intervention accomplishing this would improve decision quality at low cost and be acceptable to Veterans and clinicians.
The primary challenge to implementing routine PSA SDM counseling is clinic workflow. One solution may be to enlist non-clinician healthcare team members to offer SDM counseling. Decision coaches can provide non-directive support to help patients weigh options, prepare for provider discussions, and implement decisions. Decision coaches improve knowledge and promote SDM. In a pilot program, the investigators group trained lay health workers as decision coaches to counsel Black men considering PSA screening in a non-VA community care setting. There is an urgent need to expand this approach to all men considering PSA screening and adapt it to the VA setting. The investigators propose training Veteran peers, who are well-known to promote healthful behaviors among Veterans, to be decision coaches to promote SDM among Veterans considering PSA screening. This peer-led approach may provide excellent counseling at acceptable cost and decreased clinician burden.
The objective of this study is to test the efficacy of a Veteran-peer-navigator-led decision-coaching program (PDC) to facilitate SDM for PSA screening at VA NY Harbor. The investigators will randomize Veterans seeking primary care to receive 1) a standard of care screening decision aid (DA) along with PDC on PSA screening (intervention), or 2) the same DA without counseling (control). The outcomes of interest are decision quality, PSA utilization, acceptability and cost of the PDC program with the goal of future system-wide dissemination. Additionally, since VA is dedicated to promoting health equity through telehealth, the investigators will explore the effects of patient race (Black versus non-Black) and communication format (in-person versus telehealth).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | –Veterans randomized to the intervention arm will receive a decision aid in the mail along with decision coaching on PSA screening from a Veteran Veteran-peer-navigator decision coach. The intervention will be administered prior to the Veteran patient's appointment with the provider. |
| Control Group | No intervention | –Veteran patients in the control arm will receive a decision aid alone in the mail without any additional counseling prior to their office visit. |
Who may qualify
- Ages
- 40 to 69 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Veteran
- Male
- Attending VANYHHS-Manhattan for routine primary care appointment
- Primary care provider at VA New York Harbor Healthcare System (VANYHHS)
- Caring for patients that fit inclusion criteria
Key exclusion criteria (7 listed)
- Patients seen within 9 months of other prostate-specific antigen (PSA) tests
- Patients seen within 180 days after primary diagnosis of urinary obstruction, prostatitis, hematuria, other disorder of prostate, unexplained weight loss, or lumbar back pain
- Patients with a prior diagnosis of prostate cancer (ICD-10-CM C61)
- Patients visiting their provider for any indication other than a well-visit appointment
- Providers who do not treat adult male patients (e.g. OB/Gyns, pediatricians)
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 |
|---|---|---|
| Veteran Peer Decision Coaching Session for PSA ScreeningAlso: PDC InterventionVeterans in the intervention arm will review the content of the mailed DA, including the values clarification exercise, with the Veteran PDC. Veteran PDC Counseling includes: 1) a structured interview with the patient that focuses on determining his understanding of his prostate cancer risk, his screening options, and his goals and values related to his decision making and 2) role playing exercises to improve SDM skills. | Behavioural | – |
Primary outcome
Decisional Conflict
Time frame: Up to 3 months
The 16-item Decisional Conflict Scale (DCS) measures Veterans' perceptions of 1) uncertainty in choosing options, 2) feelings of having adequate knowledge and clear values, and 3) effective decision making. DCS is scored on a 5-point Likert scales with scores ranging from 0 (no decisional conflict) to 100 (extremely high decisional conflict)
Patient Knowledge Survey Score
Time frame: Day 1
The Patient Knowledge Survey comprises of 12-items assessing prostate cancer and PSA screening knowledge. Respondents provide an answer of "True", "Unsure", or "False". The total score is the sum of correct responses and ranges from 0 - 12 with higher scores indicating greater knowledge levels.
Decision Quality Score
Time frame: Day 1
Decision quality will be measured through 3 domains: 1) decisional conflict 2) being informed (e.g. accurate understanding about screening and its risks and benefits) and 3) making preference-concordant decisions (i.e. treatment consistent with patient preferences). The Decision Quality Balance Scale consists of 12 questions (6 Pros and 6 Cons of testing) scored on a 5 point Likert scale (Strongly Disagree to Strongly Agree) that represents the relative strengths of the pros versus the cons and ranges from -24 to +24. A high quality decision is when patients are both well-informed and making preference-concordant decisions (i.e. treatment consistent with patient preferences as determined by responses to survey questions).
Prostate-specific Antigen (PSA) Screening Rates
Time frame: Up to Month 3
Percentage of participants who receive at least one PSA screening test. Screening data is collected through patient self-report and electronic health record data.
Percentage of Participants Who Make Informed Choice (Knowledge Survey + Measure of Informed Choice Attitudes Scale)
Time frame: Day 1
The percentage of participants who make 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.
Measure of Informed Choice Attitudes Scale
Time frame: Day 1
The measure of Informed Choice evaluates the screening decision. The 4-item measure consists of items assessing knowledge, attitude towards the screening test, and a record of test uptake. The questions are graded on a 7 point Likert-type scale (1 to 7) with scores ranging from 4 to 28. The median of 22 was taken to classify men's attitudes as positive or negative, with scores 22 or above indicating positive attitudes, and those below 22 indicating negative attitudes.
6 secondary outcomes
Combined Outcome Measure for Risk communication And treatment Decision making Effectiveness (COMRADE)
Time frame: Day 1
Doctor-Patient Communication Survey
Time frame: Day 1
Decision Self-Efficacy
Time frame: Day 1
Self-efficacy for Communicating with Provider
Time frame: Day 1
Satisfaction with Decision Scale
Time frame: Up to 3 Months
Decisional Regret Scale
Time frame: Up to 3 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Background: PubMed 39675547Wright Nunes J, Kerr E, Ojo A, Powell C, Fan A, Brinley FJ, Devine A, Ellies T, Grzyb K, Garcia-Guzman L, Nakai T, Oliverio A, Chen E, Fagerlin A. Patient Education for CKD and Decision Support in Primary Care: Findings From the EPIK Pilot Study. Am J Kidney Dis. 2025 Mar;85(3):284-292. doi: 10.1053/j.ajkd.2024.10.005. Epub 2024 Dec 14.
- Individual participant dataSharing planned: No
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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.
Danil V Makarov, MD MHS principal investigator
VA NY Harbor Healthcare System, New York, NY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Veteran Peer Decision Coaching Session for PSA Screening in people with Prostate Cancer, run by VA Office of Research and Development 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 7 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: opening soon, as of the sponsor's last update on 21 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jerry K Thomas, MPH BA ((201) 316-3440, Jerry.Thomas3@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decisional Conflict (time frame: Up to 3 months). The study lists 6 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 NCT06549036, 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 21 Oct 2026.