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Clinical Trials/NCT05387863
NCT05387863
Recruiting
Not Applicable

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

NYU Langone Health1 site in 1 country40 target enrollmentSeptember 12, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Kidney Tumor
Sponsor
NYU Langone Health
Enrollment
40
Locations
1
Primary Endpoint
Knowledge Score
Status
Recruiting
Last Updated
5 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
September 12, 2022
End Date
September 1, 2026
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Knowledge Score

Time Frame: Pre-Counsel, 1 day Visit

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.

Decision Satisfaction Score

Time Frame: Post-Counsel, 1 day Visit

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.

Shared Decision Making

Time Frame: Post-Counsel, 1 day Visit

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.

Study Sites (1)

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