An interventional study of Visual and No intervention in Prostate Cancer and Kidney Cancer, sponsored by UNC Lineberger Comprehensive Cancer Center. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-05.
Sponsored by UNC Lineberger Comprehensive Cancer Center · Not applicable, Interventional, and Supportive care
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,399 are open to participants now.
This study's planned enrollment of 220 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →UNC Lineberger Comprehensive Cancer Center is the lead sponsor of 414 studies on the registry; 95 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 25 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
In order to participate in this study, a subject must meet all of the eligibility criteria outlined below.
Exclusion Criteria:
The subjects meeting the following criteria will be excluded from study participation:
For patient subjects:
Patient participants will complete a 10-minute baseline survey, 15-minute after-visit survey and 5-minute 6-month survey.
Other: No intervention
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.
No intervention
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).
Time frame: Baseline (Patient-Physician Encounter)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: 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).
Time frame: 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.
Time frame: 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
Time frame: Up to 6 months
Plan to share: No — The data will be made available upon reasonable request.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
UNC Lineberger Comprehensive Cancer Center