Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2026-02-22 @ 12:57 PM
Study NCT ID:
NCT05014295
Status:
RECRUITING
Last Update Posted:
2025-01-07
First Post:
2021-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Recall of Cancer Screening and Diagnosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital 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': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-06', 'studyFirstSubmitDate': '2021-08-13', 'studyFirstSubmitQcDate': '2021-08-13', 'lastUpdatePostDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Completeness of survey', 'timeFrame': 'at 1 week (after second survey completed)', 'description': 'Completeness: For each survey, for each participant, investigators will count the number of "don\'t know" response rates. From this, investigators will calculate the percent completeness of the survey.'}, {'measure': 'Accuracy of survey', 'timeFrame': 'at 1 week (after second survey completed)', 'description': "Investigators will assess the inter-rater reliability between the first and second survey by calculating a Cohen's Kappa coefficient. Although not a perfect assumption, investigators will use the second survey as the reference. Number of changed answers on an individual level will be calculated, representing improved accuracy. Investigators do not anticipate many changes, and, again, this will not be normally distributed."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to try to better understand how much information relating to cancer screening and diagnoses that people can recall on their own and to better understand how to help people get better information. In this study, investigators will see if giving time or other resources help individuals remember more and more accurate details about their cancer screening and care.', 'detailedDescription': 'This is a randomized controlled trial of an intervention to encourage use of online medical records for filling out a cancer screening, diagnosis and treatment questionnaire. Participants will be asked to self-report on cancer screening and treatment. They will then be asked the same questions again a week later.\n\nThe control group will have had one week to reflect on the questions, and investigators anticipate some influence of this on responses. The intervention group will be prompted about accessing their medical records from the major local health systems online, with links to directions provided by each hospital system. They will then be asked to fill out the same questionnaire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed with breast or prostate cancer within the last 10 years\n* have access to the internet with a working email address\n* reside in Northeast Ohio\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05014295', 'briefTitle': 'Patient Recall of Cancer Screening and Diagnosis', 'organization': {'class': 'OTHER', 'fullName': 'Case Comprehensive Cancer Center'}, 'officialTitle': 'Patient Recall of Cancer Screening and Diagnosis', 'orgStudyIdInfo': {'id': 'CASE1Z21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Survey questions at baseline and at one week. The control group will have had one week to reflect on the questions, and investigators anticipate some influence of this on responses.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention Group', 'description': 'The intervention group will be prompted about accessing their medical records from the major local health systems online, with links to directions provided by each hospital system. They will then be asked to fill out the same questionnaire.', 'interventionNames': ['Other: Accessing personal medical records online via online portals']}], 'interventions': [{'name': 'Accessing personal medical records online via online portals', 'type': 'OTHER', 'description': 'The participants will receive details on accessing personal medical records online via online portals, for each of the major hospital systems', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Case Comprehensive Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'centralContacts': [{'name': 'Cheryl Thompson, PhD', 'role': 'CONTACT', 'email': 'clw8@case.edu', 'phone': '216-368-3956'}], 'overallOfficials': [{'name': 'Cheryl Thompson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Case Comprehensive Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Comprehensive Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}