Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2026-01-02 @ 12:38 AM
Study NCT ID:
NCT05215769
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-09
First Post:
2022-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Video Intervention to Improve Patient Understanding of Tumor Genomic Testing in Patients With Metastatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], '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': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 243}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2022-01-18', 'studyFirstSubmitQcDate': '2022-01-18', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Message-specific knowledge/recall accuracy', 'timeFrame': 'Immediately before and immediately after video intervention', 'description': 'Measured as number correct out of 10 questions. Will have 90% power to detect an effect size of 0.47 in change of recall accuracy from pre- to post- video intervention, using a two-sided Wilcoxon signed-rank test with alpha of 0.05.'}], 'secondaryOutcomes': [{'measure': 'Change in patient genomic knowledge', 'timeFrame': 'Immediately before and immediately after video intervention', 'description': 'Measured with the validated 10 true/false question survey (% correct out of 10). Will be summarized using descriptive statistics and compared pre-/post-video using Wilcoxon signed rank test.'}, {'measure': 'Change in patient trust of physician/provider', 'timeFrame': 'Immediately before and immediately after video intervention', 'description': 'Measured with the 11-item trust in physician survey (TPS) as a single TPS score. Will be summarized using descriptive statistics and compared pre-/post-video using Wilcoxon signed rank test.'}, {'measure': 'Change in patient genomic knowledge in metastatic breast cancer (MBC) versus metastatic lung cancer (MLC) patients', 'timeFrame': 'Immediately before and immediately after video intervention', 'description': 'Measured with the validated 10 true/false question survey (% correct out of 10). Will be summarized using descriptive statistics and compared pre-/post-video using Wilcoxon signed rank test. Will be compared between MBC and MLC patients using Wilcoxon rank sum test.'}, {'measure': 'Change in patient trust of physician/provider in MBC versus MLC patients', 'timeFrame': 'Immediately before and immediately after video intervention', 'description': 'Measured with the 11-item TPS as a single TPS score. Will be summarized using descriptive statistics and compared pre-/post-video using Wilcoxon signed rank test. Will be compared between MBC and MLC patients using Wilcoxon rank sum test.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anatomic Stage IV Breast Cancer AJCC v8', 'Metastatic Breast Carcinoma', 'Metastatic Lung Carcinoma', 'Metastatic Malignant Solid Neoplasm', 'Prognostic Stage IV Breast Cancer AJCC v8', 'Stage IV Lung Cancer AJCC v8', 'Stage IVA Lung Cancer AJCC v8', 'Stage IVB Lung Cancer AJCC v8']}, 'referencesModule': {'references': [{'pmid': '38106014', 'type': 'DERIVED', 'citation': 'Veney D, Wei L, Toland AE, Presley CJ, Hampel H, Padamsee TJ, Lee CN, Irvin WJ Jr, Bishop M, Kim J, Hovick SR, Senter L, Stover DG. A Video Intervention to Improve Patient Understanding of Tumor Genomic Testing in Patients with Cancer. medRxiv [Preprint]. 2023 Dec 5:2023.12.05.23299443. doi: 10.1101/2023.12.05.23299443.'}], 'seeAlsoLinks': [{'url': 'http://cancer.osu.edu', 'label': 'The Jamesline'}]}, 'descriptionModule': {'briefSummary': 'This clinical trial tests whether a video intervention improves patient understanding of tumor genomic testing in patients with cancer that has spread to other parts of the body (metastatic). Measuring how the video intervention affects patient understanding of tumor genomic testing in patients with metastatic cancer may help doctors provide patient-centered care by effectively communicating the importance of tumor genomic testing.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To assess change in patient knowledge about tumor next generation sequencing (NGS) following exposure to the video.\n\nSECONDARY OBJECTIVES:\n\nI.To assess changes following exposure to the video, including; Ia. Genomic knowledge via the validated 10 true/false question survey (% correct out of 10).\n\nIb. 11-item Trust in Physician Survey (TPS) as a single TPS score. Ic. Comparison of results in three patient cohorts: 1) Metastatic breast cancer; 2) lung cancer; 3) metastatic cancer of unspecified type.\n\nEXPLORATORY OBJECTIVE:\n\nI. Assess whether therapies prescribed as a result of tumor NGS achieved clinically favorable result through chart review.\n\nOUTLINE:\n\nPatients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have biopsy-confirmed metastatic cancer\n* Be \\>= 18 years of age\n* Be undergoing clinical tumor or circulating tumor deoxyribonucleic acid (DNA) NGS\n\nExclusion Criteria:\n\n* Exclude patients who are not English- or Spanish-speaking'}, 'identificationModule': {'nctId': 'NCT05215769', 'briefTitle': 'A Video Intervention to Improve Patient Understanding of Tumor Genomic Testing in Patients With Metastatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University Comprehensive Cancer Center'}, 'officialTitle': 'Video Intervention to Address Pre-Test Patient Education for Tumor Genomic Testing', 'orgStudyIdInfo': {'id': 'OSU-21313'}, 'secondaryIdInfos': [{'id': 'NCI-2021-13900', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'R21CA259985', 'link': 'https://reporter.nih.gov/quickSearch/R21CA259985', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Health services research (video)', 'description': 'Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results.', 'interventionNames': ['Behavioral: Health Education', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Health Education', 'type': 'BEHAVIORAL', 'description': 'Participate in a video intervention', 'armGroupLabels': ['Health services research (video)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Complete questionnaires', 'armGroupLabels': ['Health services research (video)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University Comprehensive Cancer Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '45801', 'city': 'Lima', 'state': 'Ohio', 'country': 'United States', 'facility': "St. Rita's", 'geoPoint': {'lat': 40.74255, 'lon': -84.10523}}, {'zip': '23222', 'city': 'Richmond', 'state': 'Ohio', 'country': 'United States', 'facility': 'Saint Francis Medical Center', 'geoPoint': {'lat': 40.4334, 'lon': -80.77175}}, {'zip': '44504', 'city': 'Youngstown', 'state': 'Ohio', 'country': 'United States', 'facility': 'Saint Elizabeth Youngstown Hospital', 'geoPoint': {'lat': 41.09978, 'lon': -80.64952}}], 'overallOfficials': [{'name': 'Daniel G Stover, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University Comprehensive Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Daniel Stover', 'investigatorAffiliation': 'Ohio State University Comprehensive Cancer Center'}}}}