Visual Decision Tools for Prostate and Kidney Cancer
Designing Visual Tools to Enhance Cancer Surgeon Decision-making
Recruiting
N/AInterventional Study
Prostate CancerKidney Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Supportive Care
Participants needed
220 (estimated)
Sponsor
UNC Lineberger Comprehensive Cancer Center · Other
Who this trial is looking for
This trial is looking for patients with recently diagnosed localized prostate or kidney cancer. Participants will be asked to share their experiences and opinions about decision-making tools used by their surgeons.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years old or older.
I have been diagnosed with localized prostate cancer or a T1 renal mass.
I can give verbal consent to participate in the study.
I can follow study procedures as judged by the investigator.
I have given authorization for my personal health information to be used.
My diagnosis was made within the last 6 months.
You may not be able to join if
I do not speak English.
I cannot complete informed consent.
I have been diagnosed with advanced or metastatic cancer.
I was diagnosed more than 6 months ago.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 uniqu…
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.
Trial Locations
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Eligibility Criteria
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…
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.
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