The Personal Patient Profile Decision Support for Patients With Bladder Cancer

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT05033067
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • P3BC — BEHAVIORAL
    The decisional aid will be developed to enhance patients' communication about cystectomy and urinary diversions with the clinicians, patients' decisions and preparation for self-care. Program users will be able to choose from a menu to view and print: a) summaries of their responses to inquiry questionnaire about information needed, b) selected statistics about specific side effects and self-care, and c) streamed video vignettes with patient actors of mixed cancer stages, age, sex, and race talking with a clinician about their treatment outcomes and self-care. An automatically printed 2-page output to facilitate discussion will list: 1) decision role preference; 2) the 4 highest ranked information preference sheets; and 3) a summary of personal factors plus suggested discussion topics to address with the clinician. The 2-pages will be provided to the treating physician by the research coordinator before the patient's next consultation appointment.

Study Details

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.

Key Dates

Start date
Jun 10, 2021
Status verified
Apr 2026
Primary completion
Aug 31, 2024
Completion
Aug 31, 2024

Study Design

Enrollment
24 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • No Intervention: Usual Care
  • Experimental: Intervention (P3-BC) Usual Care
    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.

Primary Outcome Measure

Percent of Participants Who Agree Using the Acceptability Scale [ Time Frame: 1 month Follow-up ]

Locations (2)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
University of WashingtonSeattleWashington98195-9472-

Find similar trials in New York, NY

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
Icahn School of Medicine at Mount Sinai· New York, NYUniversity of Washington· Seattle, WA

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