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Decision Support Tool for Bladder Cancer (P3BC Trial)

N/A

Recruiting

Led By Nihal Mohamed, PhD

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients who have undergone cystectomy for MIBC and NMIBC

Patients must be at least 18 years old

Must not have

Existence of other cancers or ongoing cancer treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 month

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new tool to help bladder cancer patients undergoing surgery to make decisions and prepare for follow-up care.

Who is the study for?

This trial is for adults over 18 who've had their bladder removed due to muscle-invasive (MIBC) or non-muscle invasive bladder cancer (NMIBC). Participants must speak English and be able to give consent. Those with other cancers or undergoing cancer treatment can't join.

What is being tested?

The study tests a new tool called P3-BC, designed to help bladder cancer patients make decisions after surgery, communicate better with doctors, and manage follow-up care. It's a pilot study aiming to refine the tool for wider use possibly through the Internet or mobile devices.

What are the potential side effects?

Since P3-BC is a decisional support tool rather than a medication, it doesn't have physical side effects. However, participants may experience emotional or psychological impacts from engaging in decision-making about their care.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had bladder removal surgery for bladder cancer.

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I am 18 years old or older.

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I can communicate in English.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any other ongoing cancer treatments or different cancers.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability E-scale

Program Evaluation Scale

Secondary study objectives

Bladder Cancer Knowledge Scale

Brief Symptom Index (BSI-18)

Control Preferences Scale (CPS)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention (P3-BC) Usual CareExperimental Treatment1 Intervention

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.

Group II: Usual CareActive Control1 Intervention

0 / 4Eligibility criteria met