Decision Aid (DA) for Renal Patients

Not Applicable

Recruiting

• Conditions: Kidney Tumor; Renal Cancer
• Interventions: Other: Decision Aid (DA) Web Tool; Other: Institutional Pamphlet

• Registration Number: NCT05387863
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-19
• Study First Submitted QC: 2022-05-23
• Study First Posted: 2022-05-24
• Study Start: 2022-09-12
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-26
• Primary Completion: 2025-02-27
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Decision Aid (DA) Web Tool	Decision Aid (DA) Web Tool	-
Institutional Pamphlet	Institutional Pamphlet	-

Primary Outcome Measures

Name	Time	Method
Knowledge Score	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	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	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.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States