Prostate CancerNCT06965192
Designing Visual Tools to Enhance Cancer Surgeon Decision-making
A study testing Visual in people with Prostate Cancer and Kidney Cancer, run by UNC Lineberger Comprehensive Cancer Center at 2 sites in United States.
Trial summary
This prospective study will compare pre-post pilot test of surgeon-facing, visual decision support among urologists seeing patients with newly diagnosed localized prostate and kidney cancer. Up to 20 urologists (10 academic and 10 community) will be enrolled. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer, Kidney Cancer
- What is being tested?
- Visual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Apr 2025to 30 Jan 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to participate in this study, a subject must meet all of the eligibility criteria outlined below.
- Verbal informed consent was obtained to participate in the study.
- Subject is willing and able to comply with study procedures based on the judgment of the investigator or protocol designee.
- Age ≥ 18 years at the time of consent.
- For patient subjects, HIPAA authorization for the release of personal health information and a new histologic diagnosis of localized prostate cancer based on prostate biopsy or clinical diagnosis of T1 renal mass (≤7 cm in diameter) Suspicion for kidney cancer based on cross-sectional imaging. New diagnosis is defined as within 6 months of consent. T1 renal masses include solid masses or Bosniak III/IV cystic masses.
- For physician subjects, practicing urologist in North Carolina at UNC Health, Novant Health, or an affiliated site and sees patients with suspected or confirmed prostate or kidney cancer.
Who cannot join
- The subjects meeting the following criteria will be excluded from study participation:
- Non-English speaking.
- Unwilling or unable to complete informed consent.
- For patient subjects:
- Has staging information indicating locally advanced or metastatic disease. This would include PSA >50 ng/ml, imaging suggestive of distant metastasis, or lymph node involvement, renal masses >7 cm or invading in renal sinus or tumor thrombus.
- Histologic or clinical diagnosis >6 months before date of consent.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taylor Greene contact
United States2 sites, 2 recruiting
- Recruiting
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Deborah M Usinger, 919-962-0000, dusinger@email.unc.edu
Taylor L Greene, (919) 962-0000, taylor_greene@med.unc.edu
- Not yet recruiting
New Hanover Regional Medical Center
Wilmington, North Carolina, 28401
Natara Dulaney, natara.dulaney@novanthealth.org
About this study
This prospective study will compare pre-post pilot test of surgeon-facing, visual decision support among urologists seeing patients with newly diagnosed localized prostate and kidney cancer. Up to 20 urologists (10 academic and 10 community) will be enrolled. The goal will be to capture up to 10 pre- and 10 post-intervention patient encounters for each urologist with an accrual target of 200 unique patient visits (100 pre and 100 post-intervention) over a half-year period. Patient encounters pre- and post-intervention will be audio recorded, transcribed, and coded for discussion of risks/benefits of surgery and strength of recommendation. Patients and urologists will complete additional surveys on their perceptions of patient-provider communication. Urologists will further describe their experience and rate their satisfaction with visual decision support. Communication (content and perceived) will be compared pre- and post-intervention with secondary comparisons by race and care setting.
It was hypothesized that the discussion of risks and benefits of cancer surgery will increase post-intervention and that the strength of recommendation and perceptions of patient-provider communication will change. The secondary hypothesis is that these changes will differ by patient race and care setting.
- Conditions
- Prostate Cancer, Kidney Cancer
- Being tested
- Visual, No intervention
- Medical subject headings
- Prostatic Neoplasms, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VisualBehavioural
Physician participants will view the visual decision support before entering the patient's room during the intervention period, with the option to share with the patient.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Patient participants | Experimental | Patient participants will complete a 10-minute baseline survey, 15-minute after-visit survey and 5-minute 6-month survey. Receives: Other: No intervention |
| Physician participants | Experimental | Physician participants seeing patients with newly diagnosed localized prostate cancer and clinical T1 renal masses suspicious for kidney cancer. Receives: Behavioral: Visual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discussion of Risks and Benefits
The impact of visual decision support on patient-physician communication will be assessed using coding-based thematic analysis of the debriefing interviews. The Informed Decision-Making coding system, which includes 9 elements which includes the nature of the clinical problem (e.g., cancer mortality risk, life expectancy), treatment options (e.g., surgery, alternatives), risks and benefits (e.g., complications, side effects, functional outcomes), and uncertainties (e.g., range of possible outcomes). Audio-recorded patient encounters will be coded. Paired coders will score these domains as a 0 (absent), 1 (partial, brief, or one-way), or 2 (complete, two-way discussion).
Measured: Baseline (Patient-Physician Encounter)
Secondary outcomes (10)
The impact of the visual decision support on the strength of the recommendations - observer
The impact of the visual decision support on the strength of the recommendations will be assessed using coding-based thematic analysis of the debriefing interviews. An established coding approach is applied to audio-recorded patient encounters. Recommendations for surgery will be rated by paired coders from -2 to +2, with ±2 being strong, ±1 being mild, and 0 being neutral. To compare the impact of the visual decision support on communication, patient decision-making, physician decision-making, and treatment selection/quality.
Measured: Baseline (Patient-Physician Encounter)
The impact of the visual decision support on the strength of the recommendations - surgeon rated
Surgeon participants will rate the strength of recommendation after each patient visit on a 5-point Likert scale with 1 being strong against surgery, 5 being strong for surgery, and 3 being neutral.
Measured: Baseline (After-Visit)
Patient-Centered Communication
Patient-Centered Communication in Cancer will be assessed using 6-item validated scale on patient perspective of communication that incorporates questions on exchanging information, fostering relationships, making decisions, responding to emotions, enabling self-efficacy, and managing uncertainty. Maximum value=5, Minimum value=1; higher score means better outcome.
Measured: Baseline (After-Visit)
Physician Satisfaction Scale
Physician Satisfaction Scale will be assessed using the 3-item scale on physician perception of the quality of the consultation and patient's understanding of their case and treatment options. Maximum value=5, Minimum value=1; higher score means better outcome.
Measured: Baseline (After-Visit)
Patient-Physician Communication
Patient-Physician Communication will be assessed using the 1 subscale (5 items) on each surgeon's "contextual knowledge of the patient" as perceived by the patient. Maximum value=5, Minimum value=1; higher score means better outcome.
Measured: Baseline (After-Visit)
Patient Decision-Making
Patient Decision-Making includes shared decision-making, knowledge, and trust in surgical decision, decisional conflict, decisional regret, and self-efficacy will be assessed using questionnaire.
- Decisional conflict - max 100, min 0, lower score is better
- Decisional regret - max 100, min 0, lower score is better
- Trust - max 5, min 1, higher score better
- Shared Decision Making Questionnaire (SDM-Q-9) - max 45, min 0, higher score is better
- Self-Efficacy - max 5, min 1, higher score better
Measured: Up to 6 months
Physician Decision-Making
Physician Decision-Making includes perceived risk, recommendations for surgery, and whether they shared the visual decision support with the patient during the visit will be assessed.
- Risk perception (0-100)
- Surgery Rating (1-5)
Measured: Baseline (After-Visit)
Treatment Selection/Quality
Treatment Selection/Quality includes Choice of surgery (including type), Observation (including active surveillance, watchful waiting), Other treatment (e.g., radiationtherapy, ablative treatment), ancillary testing (e.g., receipt of biomarker,see condary imaging, renal mass biopsy, outside referral).
Measured: Up to12 months
Perceived Usability Ratings
Perceived Usability Ratings, including Ratings on acceptability, appropriateness, feasibility, usefulness, supportiveness, informativeness, aesthetics, and ease of use will be assessed.
Maximum value=5, Minimum value=1; higher score means better outcome.
Measured: Up to 6 months
Physician Debriefing Interview
Physician Debriefing Interview will be assessed with a study-specific interview guide. Participants will be asked for their subjective assessment of perceived usefulness, ease of use, workflow impact, and overall satisfaction. Barriers to use and suggestions for improvements will also be elicited
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start24 Apr 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jan 2028 (estimated)
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.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hung-Jui Tan, MD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06965192
- Sponsor's protocol ID
- LCC2321Aim3
- Status last verified
- Dec 2025
- First submitted
- 1 May 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be made available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Designing Visual Tools to Enhance Cancer Surgeon Decision-making
- ClinicalTrials.gov ID
- NCT06965192
- Acronym / sponsor ID
- LCC2321Aim3
- Conditions
- Prostate Cancer, Kidney Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 24 Apr 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 11 May 2025 (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.
This prospective study will compare pre-post pilot test of surgeon-facing, visual decision support among urologists seeing patients with newly diagnosed localized prostate and kidney cancer. Up to 20 urologists (10 academic and 10 community) will be enrolled. The goal will be to capture up to 10 pre- and 10 post-intervention patient encounters for each urologist with an accrual target of 200 unique patient visits (100 pre and 100 post-intervention) over a half-year period. Patient encounters pre- and post-intervention will be audio recorded, transcribed, and coded for discussion of risks/benefits of surgery and strength of recommendation. Patients and urologists will complete additional surveys on their perceptions of patient-provider communication. Urologists will further describe their experience and rate their satisfaction with visual decision support. Communication (content and perceived) will be compared pre- and post-intervention with secondary comparisons by race and care setting.
It was hypothesized that the discussion of risks and benefits of cancer surgery will increase post-intervention and that the strength of recommendation and perceptions of patient-provider communication will change. The secondary hypothesis is that these changes will differ by patient race and care setting.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient participants | Experimental | Other: No interventionPatient participants will complete a 10-minute baseline survey, 15-minute after-visit survey and 5-minute 6-month survey. |
| Physician participants | Experimental | Behavioral: VisualPhysician participants seeing patients with newly diagnosed localized prostate cancer and clinical T1 renal masses suspicious for kidney cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- In order to participate in this study, a subject must meet all of the eligibility criteria outlined below.
- Verbal informed consent was obtained to participate in the study.
- Subject is willing and able to comply with study procedures based on the judgment of the investigator or protocol designee.
- Age ≥ 18 years at the time of consent.
- For patient subjects, HIPAA authorization for the release of personal health information and a new histologic diagnosis of localized prostate cancer based on prostate biopsy or clinical diagnosis of T1 renal mass (≤7 cm in diameter) Suspicion for kidney cancer based on cross-sectional imaging. New diagnosis is defined as within 6 months of consent. T1 renal masses include solid masses or Bosniak III/IV cystic masses.
Key exclusion criteria (6 listed)
- Non-English speaking.
- Unwilling or unable to complete informed consent.
- For patient subjects:
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 |
|---|---|---|
| VisualPhysician participants will view the visual decision support before entering the patient's room during the intervention period, with the option to share with the patient. | Behavioural | Physician participants |
| No interventionNo intervention | Other | Patient participants |
Primary outcome
Discussion of Risks and Benefits
Time frame: Baseline (Patient-Physician Encounter)
The impact of visual decision support on patient-physician communication will be assessed using coding-based thematic analysis of the debriefing interviews. The Informed Decision-Making coding system, which includes 9 elements which includes the nature of the clinical problem (e.g., cancer mortality risk, life expectancy), treatment options (e.g., surgery, alternatives), risks and benefits (e.g., complications, side effects, functional outcomes), and uncertainties (e.g., range of possible outcomes). Audio-recorded patient encounters will be coded. Paired coders will score these domains as a 0 (absent), 1 (partial, brief, or one-way), or 2 (complete, two-way discussion).
10 secondary outcomes
The impact of the visual decision support on the strength of the recommendations - observer
Time frame: Baseline (Patient-Physician Encounter)
The impact of the visual decision support on the strength of the recommendations - surgeon rated
Time frame: Baseline (After-Visit)
Patient-Centered Communication
Time frame: Baseline (After-Visit)
Physician Satisfaction Scale
Time frame: Baseline (After-Visit)
Patient-Physician Communication
Time frame: Baseline (After-Visit)
Patient Decision-Making
Time frame: Up to 6 months
Physician Decision-Making
Time frame: Baseline (After-Visit)
Treatment Selection/Quality
Time frame: Up to12 months
Perceived Usability Ratings
Time frame: Up to 6 months
Physician Debriefing Interview
Time frame: Up to 6 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 5 Dec 2025.
- Clinical trials at UNC LinebergerLink provided by the sponsor.
- Individual participant dataSharing planned: No. The data will be made available upon reasonable request.
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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.
Taylor Greene contact
Hung-Jui Tan, MD principal investigator
UNC Lineberger Comprehensive Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual in people with Prostate Cancer and Kidney Cancer, run by UNC Lineberger Comprehensive Cancer Center at 2 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: looking for participants now, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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 Deborah Usinger ((919) 962-5431, dusinger@unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discussion of Risks and Benefits (time frame: Baseline (Patient-Physician Encounter)). 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 5 Dec 2025.