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Decision Aid (DA) for Renal Patients

Primary Purpose

Kidney Tumor, Renal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Decision Aid (DA) Web Tool
Institutional Pamphlet
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Kidney Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NYU Langone HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Decision Aid (DA) Web Tool

Institutional Pamphlet

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 19, 2022
Last Updated
August 23, 2023
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT05387863
Brief Title
Decision Aid (DA) for Renal Patients
Official Title
Evaluation of a Decision Aid in the Treatment Planning of Small Renal Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 12, 2022 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Tumor, Renal Cancer

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Decision Aid (DA) Web Tool
Arm Type
Experimental
Arm Title
Institutional Pamphlet
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Decision Aid (DA) Web Tool
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Institutional Pamphlet
Intervention Description
The institutional pamphlet provides information on kidney masses, but does not use risk communication, directed teaching, or interactive benefit-harm assessment.
Primary Outcome Measure Information:
Title
Knowledge Score
Description
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.
Time Frame
Pre-Counsel, 1 day Visit
Title
Decision Satisfaction Score
Description
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.
Time Frame
Post-Counsel, 1 day Visit
Title
Shared Decision Making
Description
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.
Time Frame
Post-Counsel, 1 day Visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stella Kang, MD
Phone
212-263-6246
Email
Stella.kang@nyulangone.org
First Name & Middle Initial & Last Name or Official Title & Degree
Justin Fogarty
Phone
212-731-5318
Email
Justin.Fogarty@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stella Kang, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stella Kang, MD
Email
Stella.kang@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Justin Fogarty
Email
Justin.Fogarty@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Stella Kang, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
The investigator who proposed to use the data upon reasonable request. Requests should be directed to stella.kang@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
Citations:
PubMed Identifier
36053558
Citation
Fogarty J, Siriruchatanon M, Makarov D, Langford A, Kang S. An Evaluation of a Web-Based Decision Aid for Treatment Planning of Small Kidney Tumors: Pilot Randomized Controlled Trial. JMIR Res Protoc. 2022 Sep 2;11(9):e41451. doi: 10.2196/41451.
Results Reference
derived

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Decision Aid (DA) for Renal Patients

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