Decision Aid (DA) for Renal Patients

Study Overview
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Brief Summary
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The objective of this study is to understand how patients make decisions about treating their kidney masses, and to identify key values and preferences for treating their kidney masses. The study team will develop a decision aid (DA) using the decision-analytic model to communicate personalized benefit/harm estimates to patients and promote patient-centered treatment of renal tumors.

Official Title
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Evaluation of a Decision Aid in the Treatment Planning of Small Renal Tumors

Conditions
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Kidney Tumor, Renal Cancer

Intervention / Treatment
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* Other: Decision Aid (DA) Web Tool
* Other: Institutional Pamphlet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female post-op and pre-op patients, ages 18 and older, diagnosed with a localized renal tumor up to 4 cm in diameter. Patients scheduled for standard-of-care clinical exams with the NYU Urology Department Exclusion Criteria: Stage IV cancer of any type Inability to provide informed consent Vulnerable subjects will not be recruited

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Decision Aid (DA) Web Tool<br> | Other: Decision Aid (DA) Web Tool<br>* The DA web tool provides information on kidney masses and available treatment options. It uses risk communication, directed teaching, and interactive benefit-harm assessment to present information.<br>|
| Active Comparator: Institutional Pamphlet<br> | Other: Institutional Pamphlet<br>* The institutional pamphlet provides information on kidney masses, but does not use risk communication, directed teaching, or interactive benefit-harm assessment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge Score | Via a survey, patients will be asked general questions about kidney masses and their treatments. There are 10 questions, each scored as correct or incorrect (0 or 1), and the last question has 3 sub-components each scored 0-1. The total range of score is 0-10; a score of 10 indicates strongest knowledge on kidney masses/treatments. | Pre-Counsel, 1 day Visit | 
| Decision Satisfaction Score | Via a survey, patients provide their opinion on 16 statements. Each statement is scored 1 (strongly disagree) to 5 (strongly agree). The total range of score is 1-80; a higher score indicates higher satisfaction. | Post-Counsel, 1 day Visit | 
| Shared Decision Making | This is a binary outcome measure. Patients will be asked whether or not they felt they participated in a shared decision making process: 0 for no, 1 for yes. | Post-Counsel, 1 day Visit |