Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 10:51 PM
Study NCT ID:
NCT05033067
Status:
COMPLETED
Last Update Posted:
2024-12-31
First Post:
2021-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Personal Patient Profile Decision Support for Patients With Bladder Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-30', 'studyFirstSubmitDate': '2021-08-27', 'studyFirstSubmitQcDate': '2021-08-27', 'lastUpdatePostDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptability E-scale', 'timeFrame': 'Baseline', 'description': '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'}, {'measure': 'Acceptability E-scale', 'timeFrame': '1 month followup', 'description': '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'}, {'measure': 'Acceptability E-scale', 'timeFrame': '3 month followup', 'description': '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'}, {'measure': 'Program Evaluation Scale', 'timeFrame': 'Baseline', 'description': "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."}, {'measure': 'Program Evaluation Scale', 'timeFrame': '1 month', 'description': "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."}, {'measure': 'Program Evaluation Scale', 'timeFrame': '3 month followup', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Shared Decision Making Questionnaire (SDM-Q-9)', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Shared Decision Making Questionnaire (SDM-Q-9)', 'timeFrame': '1 month', 'description': '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.'}, {'measure': 'Shared Decision Making Questionnaire (SDM-Q-9)', 'timeFrame': '3 month', 'description': '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.'}, {'measure': 'Decisional Conflict Scale', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Decisional Conflict Scale', 'timeFrame': '1 month', 'description': '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.'}, {'measure': 'Decisional Conflict Scale', 'timeFrame': '3 month', 'description': '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.'}, {'measure': 'Brief Symptom Index (BSI-18)', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Brief Symptom Index (BSI-18)', 'timeFrame': '1 month', 'description': '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.'}, {'measure': 'Brief Symptom Index (BSI-18)', 'timeFrame': '3 month', 'description': '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.'}, {'measure': 'Control Preferences Scale (CPS)', 'timeFrame': 'Baseline', 'description': "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)."}, {'measure': 'The Cancer Rehabilitation Evaluation System Medical Interaction Subscale (CARES-MIS)', 'timeFrame': 'Baseline', 'description': 'The Cancer Rehabilitation Evaluation System (CARES-MIS) - Medical Interaction Subscale will be used to assess perceived problems with communication with providers.\n\nThe 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.'}, {'measure': 'The Cancer Rehabilitation Evaluation System Medical Interaction Subscale (CARES-MIS)', 'timeFrame': '1 month', 'description': 'The Cancer Rehabilitation Evaluation System (CARES-MIS) - Medical Interaction Subscale will be used to assess perceived problems with communication with providers.\n\nThe 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.'}, {'measure': 'The Cancer Rehabilitation Evaluation System Medical Interaction Subscale (CARES-MIS)', 'timeFrame': '3 months', 'description': 'The Cancer Rehabilitation Evaluation System (CARES-MIS) - Medical Interaction Subscale will be used to assess perceived problems with communication with providers.\n\nThe 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.'}, {'measure': 'Bladder Cancer Knowledge Scale', 'timeFrame': 'Baseline', 'description': "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."}, {'measure': 'Bladder Cancer Knowledge Scale', 'timeFrame': '1 month', 'description': "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."}, {'measure': 'Bladder Cancer Knowledge Scale', 'timeFrame': '3 months', 'description': "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."}, {'measure': 'Self-Care Difficulty Scale', 'timeFrame': '1 month', 'description': '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.'}, {'measure': 'Self-Care Difficulty Scale', 'timeFrame': '3 months', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bladder cancer', 'shared decision making', 'behavioral intervention', 'urinary diversion'], 'conditions': ['Bladder Cancer']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients: cystectomy for MIBC and NMIBC;\n* at least 18 years;\n* able to communicate in English; and\n* competent to give consent.\n\nExclusion Criteria:\n\n\\- Existence of other cancers or ongoing cancer treatment.'}, 'identificationModule': {'nctId': 'NCT05033067', 'acronym': 'P3BC', 'briefTitle': 'The Personal Patient Profile Decision Support for Patients With Bladder Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'The Personal Patient Profile Decision Support for Patients With Bladder Cancer', 'orgStudyIdInfo': {'id': '19-0269'}, 'secondaryIdInfos': [{'id': '1R21NR018942-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R21NR018942-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual Care'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention (P3-BC) Usual Care', 'description': '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.', 'interventionNames': ['Behavioral: P3BC']}], 'interventions': [{'name': 'P3BC', 'type': 'BEHAVIORAL', 'otherNames': ['Personal Patient Profile - Bladder Cancer'], 'description': "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.", 'armGroupLabels': ['Intervention (P3-BC) Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '98195-9472', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Nihal Mohamed, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Immediately following publication. No end date.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).', 'accessCriteria': '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'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Washington', 'class': 'OTHER'}, {'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Nihal E Mohamed', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}