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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21NR018942-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Washington | OTHER |
| National Institute of Nursing Research (NINR) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | ||
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). | 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. | 1 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
- Existence of other cancers or ongoing cancer treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Nihal Mohamed, PhD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States | ||
| University of Washington |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Immediately following publication. No end date.
Researchers who provide a methodologically sound proposal for individual participant data meta-analysis. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website
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Among those who consented, 4 participants were lost to follow-up prior to participation, leaving 20 participants (83%) who engaged with the web-based tool's survey. Of these, 5 participants did not complete sufficient baseline survey engagement (i.e., completing the tool's survey that precedes the randomization step) with the tool and were therefore not assigned to a study group.
The remaining 15 participants were randomized, with 10 assigned to the intervention group and 5 to the usual care.
After obtaining IRB approval for the feasibility study, we approached 114 patients for recruitment into The Personal Patient Profile Decision Support for Patients with Bladder Cancer (P3-BC) study. Of these, 24 patients consented to participate. Common reasons for declining included disease and treatment burden, limited time, and lack of confidence in using technology independently.
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With Bladder Cancer | Participants who consented to participate in the study and were offered to engage with the web-based tool's survey. |
| FG001 | Intervention (P3-BC) Usual Care | 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. |
| FG002 | Usual Care | Usual Care Control Group - The group received standard bladder cancer care information only. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Consented, engaged with web-based tool |
|
| |||||||||||||||||||||
| Randomization |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention (P3-BC) Care | 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. |
| BG001 | Usual Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Data for participants who took the survey and thus randomized to the intervention group. | Posted | Number | percentage of participants | 1 month Follow-up |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention (P3-BC) Care | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nihal Mohamed, PhD | Icahn School of Medicine at Mount Sinai | (212) 241-8858 | nihal.mohamed@mountsinai.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 18, 2019 | Jan 28, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 23, 2021 | Jan 28, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
|
| 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. | 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. | 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. | 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 | 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. | 3 months follow-up |
| Seattle |
| Washington |
| 98195-9472 |
| United States |
| NOT COMPLETED |
|
|
Usual Care Control Arm - The group received standard bladder cancer care information only.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Number of Participants with Heart Disease | Count of Participants | Participants | No |
|
| Number of participants with Diabetes | Count of Participants | Participants |
|
| Number of Participants with Peripheral Neuropathy | Count of Participants | Participants |
|
| Number of participants with Chronic Kidney disease | Count of Participants | Participants |
|
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 | 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). | 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. | Posted | Count of Participants | Participants | 1 month followup |
|
|
|
| Primary | 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. | 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. | Posted | Number | percent of participants | 1 month follow-up |
|
|
|
| Secondary | 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. | One participant did not complete the 1 month follow up survey. | Posted | Mean | Standard Deviation | score on a scale | 1 month follow-up |
|
|
|
| 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 - 64 with higher total scores indicating higher decisional conflict. | Posted | Mean | Standard Deviation | score on a scale | 3 months follow-up |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 1 month follow-up and 3 month follow-up |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months follow-up |
|
|
|
| Secondary | 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 | Not Posted | Mar 2026 | 1 month follow-up | Participants |
| Secondary | 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. | Data available for participants who completed the survey | Posted | Mean | Standard Deviation | score on a scale | 3 months follow-up |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Usual Care | Usual Care Control Arm - The group received standard bladder cancer care information only. | 0 | 5 | 0 | 5 | 0 | 5 |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| Made me feel less anxious or upset about my treatment |
|
| Sort out what's important to me for decision making |
|
| Taught me how to use stoma appliances or catheters |
|
| Taught me how to care for myself after surgery |
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| Helped me reduce my anxiety about my treatment |
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| Helped me talk to doctors about my treatment options |
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| Helped me take care of myself |
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| Helped me manage my disease |
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| Prepared me for the surgery side effects |
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| How easy was the program to use? |
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| Overall satisfaction with the program |
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| Usefulness of information on statistics |
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| Was the amount of time to complete the program acceptable? |
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| Usefulness of information about top concerns |
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| How helpful was it to complete the program? |
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| How valuable was the information? |
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| Usefulness of videos |
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| Usefulness of information on role in decision-making |
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| Usefulness of links to bladder cancer websites |
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| Usefulness of examples of what to say to your doctor |
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