← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 month

Awards & highlights

P3BC Trial 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.Check my eligibility

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.See study design

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.

P3BC Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I have had bladder removal surgery for bladder cancer.

Select...

I am 18 years old or older.

Select...

I can communicate in English.

P3BC Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability E-scale

Program Evaluation Scale

Secondary outcome measures

Bladder Cancer Knowledge Scale

Brief Symptom Index (BSI-18)

Control Preferences Scale (CPS)

+4 more

P3BC 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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of WashingtonOTHER

1,741 Previous Clinical Trials

1,847,745 Total Patients Enrolled

National Institute of Nursing Research (NINR)NIH

580 Previous Clinical Trials

10,376,540 Total Patients Enrolled

Icahn School of Medicine at Mount SinaiLead Sponsor

861 Previous Clinical Trials

525,255 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the eventual goals of this clinical trial?

"The primary outcome of this study will be evaluated over a 3-month follow-up period using the Program Evaluation Scale. Secondary outcomes include the Cancer Rehabilitation Evaluation System Medical Interaction Subscale (CARES-MIS) and the Shared Decision Making Questionnaire (SDM-Q-9). The Decisional Conflict Scale will also be used to assess the effectiveness of decision making."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Personal Patient Profile Decision Support for Patients With Bladder Cancer

Nihal E Mohamed 2021. "The Personal Patient Profile Decision Support for Patients With Bladder Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05033067.

All > Bladder Cancer