Decision Aid (DA) for Renal Patients

Sponsor
NYU Langone Health (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05387863
Collaborator
(none)
213
1
2
4.1
52.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Decision Aid (DA) Web Tool
  • Other: Institutional Pamphlet
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
213 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Evaluation of a Decision Aid in the Treatment Planning of Small Renal Tumors
Anticipated Study Start Date :
Aug 29, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Decision Aid (DA) Web Tool

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.

Active Comparator: Institutional Pamphlet

Other: Institutional Pamphlet
The institutional pamphlet provides information on kidney masses, but does not use risk communication, directed teaching, or interactive benefit-harm assessment.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 NYU Langone Health New York New York United States 10016

Sponsors and Collaborators

  • NYU Langone Health

Investigators

  • Principal Investigator: Stella Kang, MD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT05387863
Other Study ID Numbers:
  • 21-01670
First Posted:
May 24, 2022
Last Update Posted:
Aug 10, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 10, 2022