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Brief Title: The Personal Patient Profile Decision Support for Patients With Bladder Cancer

The Personal Patient Profile Decision Support for Patients With Bladder Cancer

INTRODUCTION

  • Org Study ID: 19-0269
  • Secondary ID: 1R21NR018942-01A1
  • NTC ID: NCT05033067
  • Sponsor: Icahn School of Medicine at Mount Sinai

BRIEF SUMMARY

There is a pressing need to develop a personalized, value-based decisional tool for bladder cancer patients undergoing radical cystectomy (bladder removal) and urinary diversion to help them with communication with the physicians, shared decision making, and preparation for disease-management and follow-up care. The proposed intervention, the Personal Patient Profile - Bladder Cancer (P3-BC), will be the first intervention to address these issues. Results of this pilot randomized feasibility study will provide evidence of the feasibility and acceptability of the P3-BC and will guide further refinement of the tool for a larger experimental trial, with potential dissemination of the program via the Internet and hand-held computing devices.

  • Overall Status
    Recruiting
  • Start Date
    June 10, 2021
  • Phase
    Not Applicable
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Acceptability E-scale

Primary Outcome 1 - Timeframe: Baseline

Primary Outcome 2 - Measure: Acceptability E-scale

Primary Outcome 2 - Timeframe: 1 month followup

Primary Outcome 3 - Measure: Acceptability E-scale

Primary Outcome 3 - Timeframe: 3 month followup

Primary Outcome 4 - Measure: Program Evaluation Scale

Primary Outcome 4 - Timeframe: Baseline

Primary Outcome 5 - Measure: Program Evaluation Scale

Primary Outcome 5 - Timeframe: 1 month

Primary Outcome 6 - Measure: Program Evaluation Scale

Primary Outcome 6 - Timeframe: 3 month followup

CONDITION

  • Bladder Cancer

ELIGIBILITY

Inclusion Criteria:
Patients: cystectomy for MIBC and NMIBC;

- at least 18 years;

- able to communicate in English; and

- competent to give consent.
Exclusion Criteria:
- Existence of other cancers or ongoing cancer treatment.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Nihal Mohamed, PhD

Role: Principal Investigator

Affiliation: Icahn School of Medicine at Mount Sinai

Overall Contact

Name: Nihal Mohamed, PhD

Phone: 212-241-8858, 212-659-8556

Email: nihal.mohamed@mountsinai.org, holden.kata@mountsinai.org

LOCATION

Facility Status Contact
Facility: Icahn School of Medicine at Mount Sinai
New York, New York 10029
United States
Status: Recruiting Contact: Principal Investigator
Nihal Mohammed, PhD