Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-01-29 @ 7:01 PM
Study NCT ID:
NCT02032550
Status:
COMPLETED
Last Update Posted:
2020-08-04
First Post:
2013-12-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Treatment Preference and Patient Centered Prostate Cancer Care
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D057240', 'term': 'Patient Preference'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jravi@pennmedicine.upenn.edu', 'phone': '215-898-3798', 'title': 'Ravishankar Jayadevappa', 'organization': 'University of Pennsylvania'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '24 months', 'eventGroups': [{'id': 'EG000', 'title': 'Preference Based Decision Aid', 'description': 'The experimental arm of preference based decision aid intervention will complete a web-based conjoint analysis instrument for preference assessment.\n\nPreference Based Decision Aid: The objective of the preference based decision aid is to assess the treatment preferences of prostate cancer patients. The investigators will analyze the association between preferences, treatment choice and objective and subjective outcomes. The preference based decision aid will lead to a values-based patient centered treatment decision making. This will ultimately improve clinical decision making, clinical policy process, enhance patient centered care and improve prostate cancer outcomes.', 'otherNumAtRisk': 371, 'deathsNumAtRisk': 371, 'otherNumAffected': 0, 'seriousNumAtRisk': 371, 'deathsNumAffected': 4, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Usual Care', 'description': 'Participants randomized into this group will have usual care from their doctors without any intervention', 'otherNumAtRisk': 372, 'deathsNumAtRisk': 372, 'otherNumAffected': 0, 'seriousNumAtRisk': 372, 'deathsNumAffected': 4, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Satisfaction With Care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '343', 'groupId': 'OG000'}, {'value': '350', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preference Based Decision Aid', 'description': 'The experimental arm of preference based decision aid intervention will complete a web-based conjoint analysis instrument for preference assessment.\n\nPreference Based Decision Aid: The objective of the preference based decision aid is to assess the treatment preferences of prostate cancer patients. The investigators will analyze the association between preferences, treatment choice and objective and subjective outcomes. The preference based decision aid will lead to a values-based patient centered treatment decision making. This will ultimately improve clinical decision making, clinical policy process, enhance patient centered care and improve prostate cancer outcomes.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Participants randomized into this group will have usual care from their doctors without any intervention'}], 'classes': [{'title': 'Change at 3 month', 'categories': [{'measurements': [{'value': '0.26', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.05', 'groupId': 'OG001'}]}]}, {'title': 'Change at 6 month', 'categories': [{'measurements': [{'value': '0.28', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.05', 'groupId': 'OG001'}]}]}, {'title': 'Change at 12 month', 'categories': [{'measurements': [{'value': '0.31', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '0.15', 'spread': '0.05', 'groupId': 'OG001'}]}]}, {'title': 'Change at 24 month', 'categories': [{'measurements': [{'value': '0.44', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 3, 6, 12 and 24 months', 'description': 'The investigators will measure Satisfaction with Care (PSQ-18). : The PSQ-18 scale measures satisfaction with care at baseline 3, 6, 12, and 24 months. Higher score indicates better satisfaction with care. Positive change indicates improvement in satisfaction with care.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants from both groups who were analyzed at end of 24 month follow-up.'}, {'type': 'SECONDARY', 'title': 'Generic Health Related Quality of Life (HRQoL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '343', 'groupId': 'OG000'}, {'value': '350', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preference Based Decision Aid', 'description': 'The experimental arm of preference based decision aid intervention will complete a web-based conjoint analysis instrument for preference assessment.\n\nPreference Based Decision Aid: The objective of the preference based decision aid is to assess the treatment preferences of prostate cancer patients. The investigators will analyze the association between preferences, treatment choice and objective and subjective outcomes. The preference based decision aid will lead to a values-based patient centered treatment decision making. This will ultimately improve clinical decision making, clinical policy process, enhance patient centered care and improve prostate cancer outcomes.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Participants randomized into this group will have usual care from their doctors without any intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.13', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '-2.9', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 24 month', 'description': 'Generic HRQoL data is obtained from Medical Outcome Study Short Form (SF-36) that assesses 8 health domains. Scores on each domain range from 0 to 100, higher scores indicating better generic HRQoL. Change in SF-36 domain scores between baseline to 24 month will be calculated as score at 24 month-score minus score at baseline. Positive change value indicates improvement in HRQoL from baseline to 24 month.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants from both groups were analyzed at 24 month. Change in scores on domain of Physical Function is reported below.'}, {'type': 'SECONDARY', 'title': 'Anxiety', 'timeFrame': 'baseline, 3, 6, 12, and 24 months', 'description': 'Anxiety will be measured using Memorial Anxiety Scale for Prostate Cancer (MAX-PC) scale', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Urinary Symptoms', 'timeFrame': 'baseline, 3, 6, 12, and 24 months', 'description': 'The American Urological Association Symptom Index (AUA-SI) will be used to measured urinary symptoms', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Treatment Choice', 'timeFrame': '6 months', 'description': 'The investigators will obtain data on primary and secondary treatments received, such as active surveillance, radical prostatectomy (RP), robotic-assisted laparoscopic prostatectomy (RALP), external beam radiation therapy (EBRT), brachytherapy (BT) or proton therapy (PT) via self report and verified from medical chart review.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Depression', 'timeFrame': 'baseline, 3, 6, 12, and 24 months', 'description': 'The Center for Epidemiologic Studies Depression (CES-D) scale will be used to measure depression.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Satisfaction With Decision', 'timeFrame': 'baseline, 3, 6, 12, and 24 months', 'description': 'The Satisfaction with Decision (SWD) will be used to measure satisfaction with decision at 3, 6, 12 and 24 months.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Prostate Specific Health Related Quality of Life (HRQoL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '343', 'groupId': 'OG000'}, {'value': '350', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preference Based Decision Aid', 'description': 'The experimental arm of preference based decision aid intervention will complete a web-based conjoint analysis instrument for preference assessment.\n\nPreference Based Decision Aid: The objective of the preference based decision aid is to assess the treatment preferences of prostate cancer patients. The investigators will analyze the association between preferences, treatment choice and objective and subjective outcomes. The preference based decision aid will lead to a values-based patient centered treatment decision making. This will ultimately improve clinical decision making, clinical policy process, enhance patient centered care and improve prostate cancer outcomes.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Participants randomized into this group will have usual care from their doctors without any intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '59.4', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 24 month', 'description': 'Prostate specific HRQoL data is obtained from Expanded Prostate Cancer Index (EPIC), and measures four broad domains of urinary, bowel, sexual and hormonal symptoms. Scores on each sub-scale range from 0 to 100, with higher scores indicating better prostate cancer HRQoL. Proportion of participants returning to baseline scores will be calculated by comparing scores at baseline and at 24 month. Higher proportion indicates higher number of participants recovering baseline function by 24 month.', 'unitOfMeasure': 'Proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants from both groups were analyzed at 24 month. Proportion returning to baseline scores is reported for domain of urinary function below.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Preference for Participation in Treatment Decision', 'timeFrame': 'baseline, 3, 6, 12, and 24 months', 'description': 'The Control Preferences Scale (CPS) assesses the role that patients want to play and perceive playing in treatment decisions.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Decision Conflict', 'timeFrame': '12 and 24 months', 'description': 'The Decision Conflict Scale (DCS) will be used to measure decision conflict.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Physician Trust', 'timeFrame': 'baseline', 'description': 'The Patient Trust-Wake Forest Physician Trust Scale will be used to measure trust', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Preference Based Decision Aid', 'description': 'The experimental arm of preference based decision aid intervention will complete a web-based conjoint analysis instrument for preference assessment.\n\nPreference Based Decision Aid: The objective of the preference based decision aid is to assess the treatment preferences of prostate cancer patients. The investigators will analyze the association between preferences, treatment choice and objective and subjective outcomes. The preference based decision aid will lead to a values-based patient centered treatment decision making. This will ultimately improve clinical decision making, clinical policy process, enhance patient centered care and improve prostate cancer outcomes.'}, {'id': 'FG001', 'title': 'Usual Care', 'description': 'Participants randomized into this group will have usual care from their doctors without any intervention'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '371'}, {'groupId': 'FG001', 'numSubjects': '372'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '343'}, {'groupId': 'FG001', 'numSubjects': '350'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '22'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '371', 'groupId': 'BG000'}, {'value': '372', 'groupId': 'BG001'}, {'value': '743', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Preference Based Decision Aid', 'description': 'The experimental arm of preference based decision aid intervention will complete a web-based conjoint analysis instrument for preference assessment.\n\nPreference Based Decision Aid: The objective of the preference based decision aid is to assess the treatment preferences of prostate cancer patients. The investigators will analyze the association between preferences, treatment choice and objective and subjective outcomes. The preference based decision aid will lead to a values-based patient centered treatment decision making. This will ultimately improve clinical decision making, clinical policy process, enhance patient centered care and improve prostate cancer outcomes.'}, {'id': 'BG001', 'title': 'Usual Care', 'description': 'Participants randomized into this group will have usual care from their doctors without any intervention'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.9', 'spread': '8.0', 'groupId': 'BG000'}, {'value': '63.5', 'spread': '7.6', 'groupId': 'BG001'}, {'value': '63.7', 'spread': '7.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '371', 'groupId': 'BG000'}, {'value': '372', 'groupId': 'BG001'}, {'value': '743', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '355', 'groupId': 'BG000'}, {'value': '351', 'groupId': 'BG001'}, {'value': '706', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '306', 'groupId': 'BG000'}, {'value': '295', 'groupId': 'BG001'}, {'value': '601', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '371', 'groupId': 'BG000'}, {'value': '372', 'groupId': 'BG001'}, {'value': '743', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Satisfaction with care', 'classes': [{'categories': [{'measurements': [{'value': '3.96', 'spread': '0.74', 'groupId': 'BG000'}, {'value': '3.80', 'spread': '0.81', 'groupId': 'BG001'}, {'value': '3.88', 'spread': '0.77', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "In the Patient Satisfaction Questionnaire (PSQ-18) survey, 18 items are consolidated into seven subscales to assess satisfaction with medical care and six aspects of care. The subscale score ranges between 1 and 5, with a higher score indicating higher satisfaction. The PSQ-18 has demonstrated good internal consistency (Cronbach's a, .86) and excellent test-retest reliability (r, 0.92).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The baseline analysis includes all participants that were randomized to the intervention group or to the usual care group.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-07-30', 'size': 432301, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-08-07T10:43', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 743}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2018-01-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-17', 'studyFirstSubmitDate': '2013-12-23', 'resultsFirstSubmitDate': '2018-03-23', 'studyFirstSubmitQcDate': '2014-01-09', 'lastUpdatePostDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-07-17', 'studyFirstPostDateStruct': {'date': '2014-01-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Preference for Participation in Treatment Decision', 'timeFrame': 'baseline, 3, 6, 12, and 24 months', 'description': 'The Control Preferences Scale (CPS) assesses the role that patients want to play and perceive playing in treatment decisions.'}, {'measure': 'Decision Conflict', 'timeFrame': '12 and 24 months', 'description': 'The Decision Conflict Scale (DCS) will be used to measure decision conflict.'}, {'measure': 'Physician Trust', 'timeFrame': 'baseline', 'description': 'The Patient Trust-Wake Forest Physician Trust Scale will be used to measure trust'}], 'primaryOutcomes': [{'measure': 'Change in Satisfaction With Care', 'timeFrame': 'baseline, 3, 6, 12 and 24 months', 'description': 'The investigators will measure Satisfaction with Care (PSQ-18). : The PSQ-18 scale measures satisfaction with care at baseline 3, 6, 12, and 24 months. Higher score indicates better satisfaction with care. Positive change indicates improvement in satisfaction with care.'}], 'secondaryOutcomes': [{'measure': 'Generic Health Related Quality of Life (HRQoL)', 'timeFrame': 'baseline to 24 month', 'description': 'Generic HRQoL data is obtained from Medical Outcome Study Short Form (SF-36) that assesses 8 health domains. Scores on each domain range from 0 to 100, higher scores indicating better generic HRQoL. Change in SF-36 domain scores between baseline to 24 month will be calculated as score at 24 month-score minus score at baseline. Positive change value indicates improvement in HRQoL from baseline to 24 month.'}, {'measure': 'Anxiety', 'timeFrame': 'baseline, 3, 6, 12, and 24 months', 'description': 'Anxiety will be measured using Memorial Anxiety Scale for Prostate Cancer (MAX-PC) scale'}, {'measure': 'Urinary Symptoms', 'timeFrame': 'baseline, 3, 6, 12, and 24 months', 'description': 'The American Urological Association Symptom Index (AUA-SI) will be used to measured urinary symptoms'}, {'measure': 'Treatment Choice', 'timeFrame': '6 months', 'description': 'The investigators will obtain data on primary and secondary treatments received, such as active surveillance, radical prostatectomy (RP), robotic-assisted laparoscopic prostatectomy (RALP), external beam radiation therapy (EBRT), brachytherapy (BT) or proton therapy (PT) via self report and verified from medical chart review.'}, {'measure': 'Depression', 'timeFrame': 'baseline, 3, 6, 12, and 24 months', 'description': 'The Center for Epidemiologic Studies Depression (CES-D) scale will be used to measure depression.'}, {'measure': 'Satisfaction With Decision', 'timeFrame': 'baseline, 3, 6, 12, and 24 months', 'description': 'The Satisfaction with Decision (SWD) will be used to measure satisfaction with decision at 3, 6, 12 and 24 months.'}, {'measure': 'Prostate Specific Health Related Quality of Life (HRQoL)', 'timeFrame': 'Baseline to 24 month', 'description': 'Prostate specific HRQoL data is obtained from Expanded Prostate Cancer Index (EPIC), and measures four broad domains of urinary, bowel, sexual and hormonal symptoms. Scores on each sub-scale range from 0 to 100, with higher scores indicating better prostate cancer HRQoL. Proportion of participants returning to baseline scores will be calculated by comparing scores at baseline and at 24 month. Higher proportion indicates higher number of participants recovering baseline function by 24 month.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Localized prostate cancer', 'Patient preference', 'Treatment choice', 'Decision making', 'Patient centered outcomes'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '29587805', 'type': 'DERIVED', 'citation': 'Chhatre S, Jefferson A, Cook R, Meeker CR, Kim JH, Hartz KM, Wong YN, Caruso A, Newman DK, Morales KH, Jayadevappa R. Patient-centered recruitment and retention for a randomized controlled study. Trials. 2018 Mar 27;19(1):205. doi: 10.1186/s13063-018-2578-7.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to develop a preference based decision aid to assess the treatment preferences of prostate cancer patients, and to analyze the interaction of treatment preferences, type of treatment received and their relationship with health related quality of life, satisfaction with care, decision regret, and psychological health of men with localized prostate cancer.', 'detailedDescription': 'The objective is to test the comparative effectiveness of a conjoint analysis decision aid intervention compared to usual care. The investigators will identify preferred attributes of prostate cancer treatments that will help in designing a conjoint analysis decision aid to help patients weigh treatment attributes. The investigators will employ values markers to represent clusters of values for particular aspects of treatments that are valued most by individual patients. The investigators will test if the concordance between values markers and treatment received is predictive of objective outcomes and subjective outcomes. The study hypothesis is that conjoint task may help in treatment choice and prostate cancer patients whose treatment is more concordant with their values markers will have improved outcomes.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Newly diagnosed with non-metastatic prostate cancer\n2. Has not yet started radiation or surgery\n3. Provide informed consent\n\nExclusion Criteria:\n\n1. Distant, metastatic prostate cancer at diagnosis\n2. Has already begun treatment for prostate cancer\n3. Unable to communicate in English'}, 'identificationModule': {'nctId': 'NCT02032550', 'briefTitle': 'Treatment Preference and Patient Centered Prostate Cancer Care', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Treatment Preference and Patient Centered Prostate Cancer Care', 'orgStudyIdInfo': {'id': 'PCC201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Preference Based Decision Aid', 'description': 'The experimental arm of preference based decision aid intervention will complete a web-based conjoint analysis instrument for preference assessment.', 'interventionNames': ['Other: Preference Based Decision Aid']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Participants randomized into this group will have usual care from their doctors without any intervention'}], 'interventions': [{'name': 'Preference Based Decision Aid', 'type': 'OTHER', 'description': 'The objective of the preference based decision aid is to assess the treatment preferences of prostate cancer patients. The investigators will analyze the association between preferences, treatment choice and objective and subjective outcomes. The preference based decision aid will lead to a values-based patient centered treatment decision making. This will ultimately improve clinical decision making, clinical policy process, enhance patient centered care and improve prostate cancer outcomes.', 'armGroupLabels': ['Preference Based Decision Aid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Philadelphia Veteran's Affairs Medical Center", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania Health System', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19111', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Fox Chase Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Ravishankar Jayadevappa, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}, {'name': 'Corporal Michael J. Crescenz VA Medical Center', 'class': 'FED'}, {'name': 'Fox Chase Cancer Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}