Decision Aid (DA) for Renal Patients

Renal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05387863
• Other study ID #: 21-01670
• Status: Recruiting
• Phase: N/A
• Start date: September 12, 2022
• Est. completion date: October 31, 2024

Study information

• Verified date: August 2023
• Source: NYU Langone Health
• Contact: Stella Kang, MD
• Phone: 212-263-6246
• Email: Stella.kang[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 31, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Neoplasms
• Kidney Tumor
• Renal Cancer

Intervention

Other:
• Decision Aid (DA) Web Tool
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.
• Institutional Pamphlet
The institutional pamphlet provides information on kidney masses, but does not use risk communication, directed teaching, or interactive benefit-harm assessment.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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