Designing Visual Tools to Enhance Cancer Surgeon Decision-making

December 4, 2025 updated by: UNC Lineberger Comprehensive Cancer Center

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
220

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • UNC Lineberger Comprehensive Cancer Center
        • Principal Investigator:
          • Hung-Jui Tan, MD, MSHPM
        • Contact:
        • Contact:
      • Wilmington, North Carolina, United States, 28401

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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:

    1. 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.
    2. Histologic or clinical diagnosis >6 months before date of consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Patient participants
Patient participants will complete a 10-minute baseline survey, 15-minute after-visit survey and 5-minute 6-month survey.
Other: No intervention
No intervention
Experimental: Physician participants
Physician participants seeing patients with newly diagnosed localized prostate cancer and clinical T1 renal masses suspicious for kidney cancer.
Behavioral: Visual
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Baseline (Patient-Physician Encounter)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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 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.
Baseline (Patient-Physician Encounter)
The impact of the visual decision support on the strength of the recommendations - surgeon rated
Time Frame: Baseline (After-Visit)
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.
Baseline (After-Visit)
Treatment Selection/Quality
Time Frame: Up to12 months
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).
Up to12 months
Physician Debriefing Interview
Time Frame: Up to 6 months
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
Up to 6 months
Patient-Centered Communication
Time Frame: Baseline (After-Visit)
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.
Baseline (After-Visit)
Physician Satisfaction Scale
Time Frame: Baseline (After-Visit)
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.
Baseline (After-Visit)
Patient-Physician Communication
Time Frame: Baseline (After-Visit)
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.
Baseline (After-Visit)
Patient Decision-Making
Time Frame: Up to 6 months

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
Up to 6 months
Physician Decision-Making
Time Frame: Baseline (After-Visit)

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)
Baseline (After-Visit)
Perceived Usability Ratings
Time Frame: Up to 6 months

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.
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
UNC Lineberger Comprehensive Cancer Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hung-Jui Tan, MD, UNC Lineberger Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 24, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 1, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 5, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LCC2321Aim3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data will be made available upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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