The Personal Patient Profile Decision Support for Patients With Bladder Cancer

Bladder Cancer Clinical Trial

— P3BC  

Official title:

The Personal Patient Profile Decision Support for Patients With Bladder Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05033067
• Other study ID #: 19-0269
• Secondary ID: 1R21NR018942-01A
• Status: Recruiting
• Phase: N/A
• Start date: June 10, 2021
• Est. completion date: August 31, 2024

Study information

• Verified date: November 2023
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Nihal Mohamed, PhD
• Phone: 212-241-8858
• Email: nihal.mohamed[@]mountsinai.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 21
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Behavioral:
• P3BC
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.

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	University of Washington	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Institute of Nursing Research (NINR), University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability E-scale	Acceptability will be assessed with the six-item Acceptability E-scale. The acceptability is defined as 80% acceptable ratings (using mean score of more than 18 on the scale). Using well-established feasibility criteria to assess: 1) monthly screening rate, 2) monthly enrollment rate, 3) proportion of eligible patients screened who are actually recruited, 4) proportion and demographic and clinical characteristics of patients who decline to participate and reasons for refusal, 5) retention/drop-out rates, and 6) duration and completion rate of study assessments. The AES uses a 5-point response scale for each item (1=not acceptable, 5=highly acceptable). Full score from 0 - 30, with higher score indicating higher overall acceptability	Baseline
Primary	Acceptability E-scale	Acceptability will be assessed with the six-item Acceptability E-scale. The acceptability is defined as 80% acceptable ratings (using mean score of more than 18 on the scale). Using well-established feasibility criteria to assess: 1) monthly screening rate, 2) monthly enrollment rate, 3) proportion of eligible patients screened who are actually recruited, 4) proportion and demographic and clinical characteristics of patients who decline to participate and reasons for refusal, 5) retention/drop-out rates, and 6) duration and completion rate of study assessments. The AES uses a 5-point response scale for each item (1=not acceptable, 5=highly acceptable). Full score from 0 - 30, with higher score indicating higher overall acceptability	1 month followup
Primary	Acceptability E-scale	Acceptability will be assessed with the six-item Acceptability E-scale. The acceptability is defined as 80% acceptable ratings (using mean score of more than 18 on the scale). Using well-established feasibility criteria to assess: 1) monthly screening rate, 2) monthly enrollment rate, 3) proportion of eligible patients screened who are actually recruited, 4) proportion and demographic and clinical characteristics of patients who decline to participate and reasons for refusal, 5) retention/drop-out rates, and 6) duration and completion rate of study assessments. The AES uses a 5-point response scale for each item (1=not acceptable, 5=highly acceptable). Full score from 0 - 30, with higher score indicating higher overall acceptability	3 month followup
Primary	Program Evaluation Scale	Investigator-designed 12-items instrument to evaluate 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. Full scale ranges from 12-48 with higher scores indicating greater dissatisfaction with the intervention.	Baseline
Primary	Program Evaluation Scale	Investigator-designed 12-items instrument to evaluate 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. Full scale ranges from 12-48 with higher scores indicating greater dissatisfaction with the intervention.	1 month
Primary	Program Evaluation Scale	Investigator-designed 12-items instrument to evaluate 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. Full scale ranges from 12-48 with higher scores indicating greater dissatisfaction with the intervention.	3 month followup
Secondary	Shared Decision Making Questionnaire (SDM-Q-9)	Shared decision making will be assessed by the SDMQ-9, a 9-item instrument with full scale from 0-100, higher score indicates more positive attitude towards SDM.	Baseline
Secondary	Shared Decision Making Questionnaire (SDM-Q-9)	Shared decision making will be assessed by the SDMQ-9, a 9-item instrument with full scale from 0-100, higher score indicates more positive attitude towards SDM.	1 month
Secondary	Shared Decision Making Questionnaire (SDM-Q-9)	Shared decision making will be assessed by the SDMQ-9, a 9-item instrument with full scale from 0-100, higher score indicates more positive attitude towards SDM.	3 month
Secondary	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 - 100 with higher total scores indicating higher decisional conflict.	Baseline
Secondary	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 - 100 with higher total scores indicating higher decisional conflict.	1 month
Secondary	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 - 100 with higher total scores indicating higher decisional conflict.	3 month
Secondary	Brief Symptom Index (BSI-18)	Brief Symptom Index (BSI-18) will be used psychological to assess distress. BSI-18 is a self-report 18-item instrument. Raw scores on the BSI-18 are converted to t-scores based on gender-specific normative data from non-patient community dwelling U.S. adults. A T-score = 50 indicating average function compared to the reference population and a standard deviation of 10, with a higher score indicating more symptom.	Baseline
Secondary	Brief Symptom Index (BSI-18)	Brief Symptom Index (BSI-18) will be used psychological to assess distress. BSI-18 is a self-report 18-item instrument. Raw scores on the BSI-18 are converted to t-scores based on gender-specific normative data from non-patient community dwelling U.S. adults. A T-score = 50 indicating average function compared to the reference population and a standard deviation of 10, with a higher score indicating more symptom.	1 month
Secondary	Brief Symptom Index (BSI-18)	Brief Symptom Index (BSI-18) will be used psychological to assess distress. BSI-18 is a self-report 18-item instrument. Raw scores on the BSI-18 are converted to t-scores based on gender-specific normative data from non-patient community dwelling U.S. adults. A T-score = 50 indicating average function compared to the reference population and a standard deviation of 10, with a higher score indicating more symptom.	3 month
Secondary	Control Preferences Scale (CPS)	The Control Preferences Scale (CPS) consists of 5 statements designed to elicit patients' preferences for control over decision making. The CPS involves subjects in making a series of paired comparisons to provide their total preference order over the five statements. Six scores are possible based on the subject's two most preferred roles: active-active, active-collaborative, collaborative-active, collaborative-passive, passive-collaborative, and passive-passive. These scores are grouped as: active (active-active or active-collaborative), collaborative (collaborative-active or collaborative-passive), or passive (passive-collaborative or passive-passive).	Baseline
Secondary	The Cancer Rehabilitation Evaluation System Medical Interaction Subscale (CARES-MIS)	The Cancer Rehabilitation Evaluation System (CARES-MIS) - Medical Interaction Subscale will be used to assess perceived problems with communication with providers.; The CARES - Medical Interaction Subscale includes 11items 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 with higher scores indicating poorer perceived communication.	Baseline
Secondary	The Cancer Rehabilitation Evaluation System Medical Interaction Subscale (CARES-MIS)	The Cancer Rehabilitation Evaluation System (CARES-MIS) - Medical Interaction Subscale will be used to assess perceived problems with communication with providers.; The CARES - Medical Interaction Subscale includes 11items 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 with higher scores indicating poorer perceived communication.	1 month
Secondary	The Cancer Rehabilitation Evaluation System Medical Interaction Subscale (CARES-MIS)	The Cancer Rehabilitation Evaluation System (CARES-MIS) - Medical Interaction Subscale will be used to assess perceived problems with communication with providers.; The CARES - Medical Interaction Subscale includes 11items 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 with higher scores indicating poorer perceived communication.	3 months
Secondary	Bladder Cancer Knowledge Scale	20 investigator-designed items will evaluate patients' knowledge about bladder cancer.Scores range from 1 (Completely certain that is true) to 5 (Completely certain that is false). Total scale from 20-100, with higher scores indicating less knowledge about bladder cancer.	Baseline
Secondary	Bladder Cancer Knowledge Scale	20 investigator-designed items will evaluate patients' knowledge about bladder cancer.Scores range from 1 (Completely certain that is true) to 5 (Completely certain that is false). Total scale from 20-100, with higher scores indicating less knowledge about bladder cancer.	1 month
Secondary	Bladder Cancer Knowledge Scale	20 investigator-designed items will evaluate patients' knowledge about bladder cancer.Scores range from 1 (Completely certain that is true) to 5 (Completely certain that is false). Total scale from 20-100, with higher scores indicating less knowledge about bladder cancer.	3 months
Secondary	Self-Care Difficulty Scale	Self-Care Difficulty Scale - Difficulties in self-care will be assessed through 7 investigator-designed items. Scores range from No (0) or Yes (1), with full scale from 0-7. A higher score indicates greater difficulties in self-care.	1 month
Secondary	Self-Care Difficulty Scale	Self-Care Difficulty Scale - Difficulties in self-care will be assessed through 7 investigator-designed items. Scores range from No (0) or Yes (1), with full scale from 0-7. A higher score indicates greater difficulties in self-care.	3 months