Bladder CancerP3BCNCT05033067

The Personal Patient Profile Decision Support for Patients With Bladder Cancer

A study testing P3BC in people with Bladder Cancer, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Bladder Cancer
What is being tested?: P3BC
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 2 sitesUnited States
Study dates: 10 Jun 2021to 31 Aug 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients: cystectomy for MIBC and NMIBC;
at least 18 years;
able to communicate in English; and
competent to give consent.

Who cannot join

Existence of other cancers or ongoing cancer treatment.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Icahn School of Medicine at Mount Sinai
New York, New York, 10029
University of Washington
Seattle, Washington, 98195-9472

Other trials in United States

About this study

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.

Conditions: Bladder Cancer
Being tested: P3BC
Keywords: bladder cancer, shared decision making, behavioral intervention, urinary diversion
Medical subject headings: Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

P3BCBehavioural
Also called Personal Patient Profile - Bladder Cancer
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 groups in NCT05033067
Study group	Role	What they receive
Usual Care	No intervention	Not described
Intervention (P3-BC) Usual Care	Experimental	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. Receives: Behavioral: P3BC

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent of Participants Who Agree Using the Acceptability Scale
Percentage of participants who agreed with the statements taken from the Survey-based Acceptability Measure
Acceptability is assessed with the 13-item web-based scale in addition to items designed by the research team for the 1-month follow-up to evaluate acceptability. The acceptability is defined as 80% acceptable ratings. Using well-established feasibility criteria to assess: 1) retention/drop-out rates, and 2) duration and completion rate of study assessments. The scale uses a 5-point response scale for each item (1=not acceptable, 5=highly acceptable). Responses were categorized to agree (scores 1-2 strongly agree/agree), or disagree (scores 3-5; strongly disagree, disagree, I don't know.
Measured: 1 month Follow-up
Number of Participants Who Agree or Disagree With Statements on the Acceptability E-scale
A 1-month follow-up questionnaire included 11 additional items assessing participants' perceptions of study procedures, acceptance of the intervention, and satisfaction with the decision aid. Responses were categorized to agree (scores 1-2 strongly agree/agree), or disagree (scores 3-5; strongly disagree, disagree, I don't know).
Measured: 1 month followup
Percent of Participants Agreeing or Disagreeing With the Decision Using the Program Evaluation Scale
Investigator-designed 12-items instrument to evaluate intervention participants' opinions and acceptance of study procedures and their satisfaction with the decisional aid. Responses for each item range from strongly agree (1) to strongly disagree (4), with higher scores indicating greater dissatisfaction with the intervention. Original responses (1-5 visual analogue scale) were categorized as Low (scores 1-2), Neutral (score 3), or High (scores 4-5). with higher scores indicating greater dissatisfaction with the intervention.
Measured: 1 month follow-up

Secondary outcomes (6)

Shared Decision Making Questionnaire (SDM-Q-9)
Shared decision making (SDM) was assessed by the SDMQ-9. The 9 items are rated on a 6-point Likert scale ranging from 0 (completely disagree) to 5 (completely agree). Final scores are sum of rating, which ranges between 0 and 45, higher score indicates more positive attitude towards SDM.
Measured: 1 month follow-up
Decisional Conflict Scale
Consists of 16 item scale measuring effectiveness on decision making. Items are given a score value of 0 = strongly agree, 1 = agree, 2 = neither agree nor disagree, 3= disagree, and 4 = disagree, full scale from 0 - 64 with higher total scores indicating higher decisional conflict.
Measured: 3 months follow-up
Brief Symptom Index (BSI-18)
Brief Symptom Index (BSI-18) was used psychological to assess distress. BSI-18 is a self-report 18-item instrument. Index full scale is scored .00 to 0.94 with higher scores indicating more distress.
Measured: 1 month follow-up and 3 month follow-up
Decisional Regret Scale
The Decisional Regret Scale consists of 5 item scale assessing regret of treatment decisions made. Each item scored from 1 to 5. Full scale is scored 1-25. Higher score indicates higher regret of treatment decisions.
Measured: 3 months follow-up
The Cancer Rehabilitation Evaluation System Medical Interaction Subscale (CARES-MIS)
The Cancer Rehabilitation Evaluation System (CARES-MIS) - Medical Interaction Subscale was used to assess perceived problems with communication with providers.
The CARES - Medical Interaction Subscale includes 11 items rated on 5-point scale, where 0 represents "not at all" and 4 represents that problem occurred "very much". Total scores range from 0-44 for The CARES-MIS.
5 items were selected from The CARES-MIS, total subscale score range is 0-20, with higher scores indicating poorer perceived communication
Measured: 1 month follow-up
Bladder Cancer Knowledge Scale
A 14 investigator-designed items evaluating patients' knowledge about bladder cancer. Scores range from 1 (Completely certain that is true) to 5 (Completely certain that is false). After recording the items to 1 (true) and 0 (false) total sum score of this scale range from 0 -14, with higher scores indicating more knowledge about bladder cancer.
Measured: 3 months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jun 202131 Aug 2024

First posted2 Sep 2021
Study start10 Jun 2021
Primary completion31 Aug 2024
Study completion31 Aug 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Bladder CancerStudies of the same condition, open and under way.
More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05033067
Sponsor's protocol ID: GCO 19-0269
Other IDs: 1R21NR018942-01A1
Acronym: P3BC
Status last verified: Apr 2026
First submitted: 27 Aug 2021
Last updated: 24 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Evaluation for NCI Surgery Branch Clinical Research Protocols
Synovial Cell Cancer, Melanoma
RecruitingObservational study
Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease
Malignant Neoplasms, Hereditary Neoplastic Syndromes
Active, not recruiting
An Education and Navigation Support Tool to Improve Participation in Care Coordination Among Patients With Locally Advanced, Metastatic and Unresectable Bladder Cancer and Their Caregivers
Locally Advanced Bladder Carcinoma, Metastatic Bladder Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
Active, not recruitingObservational study
Association of POCD With Circulating Biomarkers in Patients Undergoing TUR of Bladder Tumor
Cognitive Decline, Urinary Bladder Cancer

All Bladder Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Personal Patient Profile Decision Support for Patients With Bladder Cancer
ClinicalTrials.gov ID: NCT05033067
Acronym / sponsor ID: P3BC / GCO 19-0269
Conditions: Bladder Cancer
Keywords: bladder cancer, shared decision making, behavioral intervention, urinary diversion
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Icahn School of Medicine at Mount SinaiUniversity, hospital or other
Collaborators: University of Washington, National Institute of Nursing Research (NINR)
Study start: 10 Jun 2021 (actual)
Primary completion: 31 Aug 2024 (actual)
Study completion: 31 Aug 2024 (actual)
First posted: 2 Sep 2021 (actual)
Results: Posted 24 Apr 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Usual Care	No intervention	–
Intervention (P3-BC) Usual Care	Experimental	Behavioral: P3BCintervention + 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patients: cystectomy for MIBC and NMIBC;
at least 18 years;
able to communicate in English; and
competent to give consent.

Key exclusion criteria (1 listed)

Existence of other cancers or ongoing cancer treatment.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
P3BCAlso: Personal Patient Profile - Bladder CancerThe 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.	Behavioural	Intervention (P3-BC) Usual Care

Primary outcome

Percent of Participants Who Agree Using the Acceptability Scale
Time frame: 1 month Follow-up
Percentage of participants who agreed with the statements taken from the Survey-based Acceptability Measure Acceptability is assessed with the 13-item web-based scale in addition to items designed by the research team for the 1-month follow-up to evaluate acceptability. The acceptability is defined as 80% acceptable ratings. Using well-established feasibility criteria to assess: 1) retention/drop-out rates, and 2) duration and completion rate of study assessments. The scale uses a 5-point response scale for each item (1=not acceptable, 5=highly acceptable). Responses were categorized to agree (scores 1-2 strongly agree/agree), or disagree (scores 3-5; strongly disagree, disagree, I don't know.
Number of Participants Who Agree or Disagree With Statements on the Acceptability E-scale
Time frame: 1 month followup
A 1-month follow-up questionnaire included 11 additional items assessing participants' perceptions of study procedures, acceptance of the intervention, and satisfaction with the decision aid. Responses were categorized to agree (scores 1-2 strongly agree/agree), or disagree (scores 3-5; strongly disagree, disagree, I don't know).
Percent of Participants Agreeing or Disagreeing With the Decision Using the Program Evaluation Scale
Time frame: 1 month follow-up
Investigator-designed 12-items instrument to evaluate intervention participants' opinions and acceptance of study procedures and their satisfaction with the decisional aid. Responses for each item range from strongly agree (1) to strongly disagree (4), with higher scores indicating greater dissatisfaction with the intervention. Original responses (1-5 visual analogue scale) were categorized as Low (scores 1-2), Neutral (score 3), or High (scores 4-5). with higher scores indicating greater dissatisfaction with the intervention.

6 secondary outcomes

Shared Decision Making Questionnaire (SDM-Q-9)
Time frame: 1 month follow-up
Decisional Conflict Scale
Time frame: 3 months follow-up
Brief Symptom Index (BSI-18)
Time frame: 1 month follow-up and 3 month follow-up
Decisional Regret Scale
Time frame: 3 months follow-up
The Cancer Rehabilitation Evaluation System Medical Interaction Subscale (CARES-MIS)
Time frame: 1 month follow-up
Bladder Cancer Knowledge Scale
Time frame: 3 months follow-up

Results and safety

Results posted to the registry on 24 Apr 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Participants With Bladder Cancer	24	15
Intervention (P3-BC) Usual Care	0	0
Usual Care	0	0

Primary outcome: Percent of Participants Who Agree Using the Acceptability Scale

Time frame: 1 month Follow-up. Number. Unit: percentage of participants

Measure	Intervention (P3-BC) Usual Care n = 8
Helped me make my treatment decisions	71.4
Increased my knowledge about my treatment (diversion options)	62.5
Made me feel less anxious or upset about my treatment	62.5
Sort out what's important to me for decision making	62.5
Taught me how to use stoma appliances or catheters	62.5
Taught me how to care for myself after surgery	62.5
Helped me reduce my anxiety about my treatment	62.5
Helped me talk to doctors about my treatment options	50.0

Population analysed: Data for participants who took the survey and thus randomized to the intervention group.

Primary outcome: Number of Participants Who Agree or Disagree With Statements on the Acceptability E-scale

Time frame: 1 month followup. Count of participants. Unit: Participants

Measure	Agree n = 8	Disagree n = 8
Helped me make my treatment decisions	6	2
Increased my knowledge about my treatment (diversion options)	5	3
Made me feel less anxious or upset about my treatment	5	3
Sort out what's important to me for decision making	5	3
Taught me how to use stoma appliances or catheters	5	3
Taught me how to care for myself after surgery	5	3
Helped me reduce my anxiety about my treatment	5	3
Helped me talk to doctors about my treatment options	4	4

Population analysed: In addition to receiving usual care, participants had access to the aid and related materials before consultation with the physician about cystectomy and urinary diversion.Data for participants who took the survey and thus randomized to the intervention group.

Primary outcome: Percent of Participants Agreeing or Disagreeing With the Decision Using the Program Evaluation Scale

Time frame: 1 month follow-up. Number. Unit: percent of participants

Measure	Low (1-2) n = 10	Neutral (3) n = 10	High (4-5) n = 10
How understandable were the questions?	0	0	100
How easy was the program to use?	0	14	86
Overall satisfaction with the program	0	14	86
Usefulness of information on statistics	14	0	86
Was the amount of time to complete the program acceptable?	0	29	71
Usefulness of information about top concerns	28	14	58
How helpful was it to complete the program?	14	29	57
How valuable was the information?	14	14	72

Population analysed: Data collected for participants who completed the web-based survey. Some participants did not reply to each item. These participants, in addition to receiving usual care, patients had access to the aid and related materials before consultation with the physician about cystectomy and urinary diversion.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention (P3-BC) Care	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Usual Care	0 of 5 (0%)	0 of 5 (0%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Related trials for Bladder Cancer

RecruitingObservational study
Evaluation for NCI Surgery Branch Clinical Research Protocols
Synovial Cell Cancer, Melanoma
RecruitingObservational study
Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease
Malignant Neoplasms, Hereditary Neoplastic Syndromes
Active, not recruiting
An Education and Navigation Support Tool to Improve Participation in Care Coordination Among Patients With Locally Advanced, Metastatic and Unresectable Bladder Cancer and Their Caregivers
Locally Advanced Bladder Carcinoma, Metastatic Bladder Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
Active, not recruitingObservational study
Association of POCD With Circulating Biomarkers in Patients Undergoing TUR of Bladder Tumor
Cognitive Decline, Urinary Bladder Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nihal Mohamed, PhD principal investigator

Icahn School of Medicine at Mount Sinai

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing P3BC in people with Bladder Cancer, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of Participants Who Agree Using the Acceptability Scale (time frame: 1 month Follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05033067.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.