The Personal Patient Profile Decision Support for Patients With Bladder Cancer (P3BC)

Mount Sinai Health System

Status: Completed

Conditions: Bladder Cancer

Treatments: Behavioral: P3BC

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05033067

1R21NR018942-01A1 (U.S. NIH Grant/Contract)

19-0269

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Usual Care

No Intervention group

Intervention (P3-BC) Usual Care

Experimental group

Description:

intervention + usual care group. In addition to receiving usual care, patients will have access to the aid and related materials before consultation with the physician about cystectomy and urinary diversion.

Treatment:

Behavioral: P3BC