Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2026-01-01 @ 12:33 PM
Study NCT ID:
NCT01244568
Status:
COMPLETED
Last Update Posted:
2014-12-23
First Post:
2010-11-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Decision Support Interventions (DESI) for Prostate Cancer Screening and Treatment - Study 2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 218}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-19', 'studyFirstSubmitDate': '2010-11-15', 'studyFirstSubmitQcDate': '2010-11-18', 'lastUpdatePostDateStruct': {'date': '2014-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of Active treatment vs. Watchful waiting/active surveillance at 3 and 6 months', 'timeFrame': '3 and 6 month follow-up', 'description': 'Men who review a DESI before making a treatment decision will be more likely to choose active surveillance/watchful waiting and will have better decision-specific knowledge.'}], 'secondaryOutcomes': [{'measure': 'DESI viewing', 'timeFrame': '3 month follow-up (phone survey)', 'description': 'Decision aid viewing is a self-reported measures. Patients will be asked if they viewed the DVD that was given to them (intervention group)prior to them making a treatment choice decision.'}, {'measure': 'Healthcare utilization', 'timeFrame': '6 month follow-up', 'description': 'Research staff will review EMR data to access decision-making outcomes and resource utilization.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prostate Cancer', 'Decision support interventions (DESI)', 'Comparative Effectiveness Research (CER)'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'Researchers in this study will determine whether providing decision support interventions (DESIs) to men with low risk prostate cancer improves their decision-specific knowledge and alters their treatment decisions.', 'detailedDescription': 'Potentially eligible men (age 45 and older who have localized prostate cancer with a Gleason score of 6 or less) will be identified and recruited to participate in the study before their next office visit. Patients who are interested and provide informed consent will be asked to complete a brief survey about background, medical history, knowledge of prostate cancer and health-related quality of life. Once the survey is completed the patient will be randomly assigned to one of 2 groups. Those assigned to the "Usual Care" group will not receive any additional information materials as part of their participation in the study. Those assigned to the "Patient Decision Support" group will receive a DVD program that contains information about treatment choices for prostate cancer.\n\nParticipants will be asked to answer a brief telephone survey at 3 and 6 months from the day of their last office visit. Survey questions will ask about knowledge about prostate cancer, health-related quality of life, whether or not the DVD was viewed and what treatment decision was made.\n\nResearch staff will also review medical records 6 months after enrollment to determine which treatment was received for prostate cancer, how many visits with health care providers were completed since enrollment and which medical services and procedures were received.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge 45 or older Localized prostate cancer with a Gleason score of 6 or less\n\nExclusion Criteria:\n\nWomen'}, 'identificationModule': {'nctId': 'NCT01244568', 'briefTitle': 'Decision Support Interventions (DESI) for Prostate Cancer Screening and Treatment - Study 2', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Acceleration Adoption of Comparative Effectiveness Research Results With Patient Decision Support Intervention and Treatment- Study 2', 'orgStudyIdInfo': {'id': '10-1318'}, 'secondaryIdInfos': [{'id': '1R18AE000023-01', 'link': 'https://reporter.nih.gov/quickSearch/1R18AE000023-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual care'}, {'type': 'EXPERIMENTAL', 'label': 'Prostate cancer treatment DESI', 'interventionNames': ['Behavioral: Prostate cancer treatment DESI']}], 'interventions': [{'name': 'Prostate cancer treatment DESI', 'type': 'BEHAVIORAL', 'otherNames': ['Decision Support Intervention'], 'description': "DESI is a 50 minute program on treatment choices for prostate cancer that will be given out to the experimental group. The program explains several treatment options including surgery (radical prostatectomy), radiation therapy (external beam and/or brachytherapy), hormone therapy, and active surveillance and watchful waiting. The program's intended audience is men with early state prostate cancer who are trying to make a treatment decision.", 'armGroupLabels': ['Prostate cancer treatment DESI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94301', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Palo Alto Medical Foundation Research Institute', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina, Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Carmen L Lewis, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}, {'name': 'Ming Tai-Seale, Ph.D, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Palo Alto Medical Foundation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'Palo Alto Medical Foundation', 'class': 'OTHER'}, {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Carmen Lewis, MD, MPH', 'investigatorAffiliation': 'University of North Carolina, Chapel Hill'}}}}