Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2026-02-25 @ 8:11 PM
Study NCT ID:
NCT05764005
Status:
COMPLETED
Last Update Posted:
2024-06-07
First Post:
2023-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimizing Active Surveillance in Low-Risk Prostate Cancer: a Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-08-13', 'releaseDate': '2025-07-29'}, {'resetDate': '2025-09-23', 'releaseDate': '2025-09-03'}, {'resetDate': '2025-10-29', 'releaseDate': '2025-10-16'}, {'releaseDate': '2025-12-23'}], 'estimatedResultsFirstSubmitDate': '2025-07-29'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-03-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-06', 'studyFirstSubmitDate': '2023-02-28', 'studyFirstSubmitQcDate': '2023-02-28', 'lastUpdatePostDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility - recruitment', 'timeFrame': 'up to 9 months post last patient recruitment', 'description': 'Defined as the successful recruitment of 40 patients.'}, {'measure': 'Feasibility - Uptake', 'timeFrame': 'up to 6 months post last patient recruitment', 'description': 'Defined as the proportion of men who complete the baseline and follow-up surveys out of the total number of patients recruited.'}, {'measure': 'Acceptability - Mean Satisfaction Scores', 'timeFrame': 'up to 4 months post last patient completing intervention', 'description': 'Acceptability asks the extent to which participants consider the intervention is agreeable. Patients in the intervention arm will answer questions (on a 5-point Likert scale) regarding the use of the tool including: a) the tool provided me the necessary information about being on active surveillance; b) the tool helped me know what tests I needed and when; c) the tool helped me understand what my PCP can do for my active surveillance; d) the tool was easy to use; e) the amount of time it took to go through the website; and f) I would recommend the tool to other patients. We will ask an open-ended question on if the tool should have any other features in future versions. We will additionally collect paradata such as user actions (clicks) and time spent on each webpage.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['low-risk', 'active surveillance'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This is a pilot evaluation of a patient-centered intervention that enables providers to support men on active surveillance to maximize adherence. Conducted in urology practices, this pilot will measure key patient-reported, provider-reported, and implementation outcomes. Successful completion of this work will inform a subsequent multi-center effectiveness-implementation hybrid design trial and ultimately will improve low-risk cancer management by effectively engaging Primary Care Physicians (PCPs) in care delivery.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Patient Inclusion Criteria:\n\n* 55 years old or older\n* Men diagnosed with low-risk prostate cancer currently on active surveillance\n* Men who identify having a primary care provider\n* Access and ability to use the Internet\n\nPatient Exclusion Criteria:\n\n* Men who are unable to read and/or speak English\n* Men with impaired decision-making capacity (such as with a diagnosis of dementia or memory loss)\n\nPCP Inclusion Criteria:\n\n* Identified by patient on baseline survey as their PCP\n\nUrologist and Clinic Staff Inclusion Criteria:\n\n* Clinicians or staff at a participating urology clinic, including but not limited to MDs, APPs, and nurses'}, 'identificationModule': {'nctId': 'NCT05764005', 'briefTitle': 'Optimizing Active Surveillance in Low-Risk Prostate Cancer: a Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan Rogel Cancer Center'}, 'officialTitle': 'Optimizing Active Surveillance in Low-Risk Prostate Cancer: a Pilot Study', 'orgStudyIdInfo': {'id': 'UMCC 2022.059'}, 'secondaryIdInfos': [{'id': 'HUM00209599', 'type': 'OTHER', 'domain': 'University of Michigan'}, {'id': '5K08CA245237', 'link': 'https://reporter.nih.gov/quickSearch/5K08CA245237', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention website', 'interventionNames': ['Behavioral: web-based tool (MAP- Management of Active surveillance in Prostate Cancer)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control MUSIC website', 'description': 'This is usual care and all urologists are encouraged to refer their patients to the patient educational materials on the MUSIC website (http://www.musicurology.com/patientmaterials/).', 'interventionNames': ['Behavioral: MUSIC website']}], 'interventions': [{'name': 'web-based tool (MAP- Management of Active surveillance in Prostate Cancer)', 'type': 'BEHAVIORAL', 'description': 'A web-based tool with modules on active surveillance education, team based active surveillance care delivery and the role of the PCP, and self-management for cancer anxiety and worry. {may need more detail}', 'armGroupLabels': ['Intervention website']}, {'name': 'MUSIC website', 'type': 'BEHAVIORAL', 'description': 'Standard of care educational materials {add more detail}', 'armGroupLabels': ['Control MUSIC website']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Rogel Cancer Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Archana Radhakrishnan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan Rogel Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan Rogel Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-07-29', 'type': 'RELEASE'}, {'date': '2025-08-13', 'type': 'RESET'}, {'date': '2025-09-03', 'type': 'RELEASE'}, {'date': '2025-09-23', 'type': 'RESET'}, {'date': '2025-10-16', 'type': 'RELEASE'}, {'date': '2025-10-29', 'type': 'RESET'}], 'unpostedResponsibleParty': 'University of Michigan Rogel Cancer Center'}}}}