Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 11:56 PM
Study NCT ID:
NCT04820894
Status:
WITHDRAWN
Last Update Posted:
2025-05-23
First Post:
2021-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perception of Cure Among Patients With Metastatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057286', 'term': 'Electronic Health Records'}], 'ancestors': [{'id': 'D016347', 'term': 'Medical Records Systems, Computerized'}, {'id': 'D008499', 'term': 'Medical Records'}, {'id': 'D011996', 'term': 'Records'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Feasibility', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-22', 'studyFirstSubmitDate': '2021-03-25', 'studyFirstSubmitQcDate': '2021-03-25', 'lastUpdatePostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients', 'timeFrame': 'Up to 2 years', 'description': "Will assess the percentage of patients who anticipate cure before starting immunotherapy, scoring a '1' on the Perception of cure tool, and anticipate \\>75% chance for a cure."}, {'measure': 'Patient Reported Outcomes Measurement Information System (PROMIS)', 'timeFrame': 'Up to 2 years', 'description': 'Descriptive analyses (e.g. frequency statistics) will be used to characterize the sample and to look at the association between Patient Reported Outcomes Measurement Information System (PROMIS) tool score with perception of cure score.'}, {'measure': 'Functional Assessment of Cancer Therapy-General (FACT-G)', 'timeFrame': 'Up to 2 years', 'description': 'Descriptive analyses (e.g. frequency statistics) will be used to characterize the sample and to look at the association between Functional Assessment of Cancer Therapy-General (FACT-G) overall score with perception of cure score.'}, {'measure': 'Perceptions of cure', 'timeFrame': 'Up to 2 years', 'description': 'Chi-square analyses will be used to examine perceptions of cure by sociodemographic characteristics:\n\ngender (male and female), age (\\< 60 and \\> 60), and ethnicity (white non-Hispanic, Hispanic, and other).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hematopoietic and Lymphoid Cell Neoplasm', 'Metastatic Malignant Solid Neoplasm']}, 'descriptionModule': {'briefSummary': "This study collects information about perception of cure among patients with cancer that has spread to other places in the body (metastatic). This study aims to determine patients' perception (knowledge) before starting immunotherapy and if differences exist in understanding of treatment to stimulate or restore the ability of the body's immune (defense) system to fight infection and disease (immunotherapy) based on social and economic factors or on race/ethnicity.", 'detailedDescription': "PRIMARY OBJECTIVE:\n\nI. To assess the proportion of patients with metastatic cancer who anticipate cure before starting immunotherapy.\n\nSECONDARY OBJECTIVES:\n\nI. To determine if expectations of cure are associated with quality of life and distress.\n\nII. To determine if patients' perceptions differ by gender, age, and ethnicity.\n\nOUTLINE:\n\nPatients complete surveys over 30 minutes about sociodemographic information and perception of immunotherapy, over 10 minutes about expectations of cure, over 10 minutes about anxiety, over 10 minutes about depression, and over 30 minutes about physical well-being. Patients' medical records are reviewed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with metastatic cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Eligibility Criteria:\n\n1. Patients must be aged 18 and over\n2. Patients sufficiently fluent in English\n3. Patients must have a cytologically or pathologically verified diagnosis of cancer\n4. Patients must have measurable metastatic disease\n5. Patients must be initiating immunotherapy\n6. Patients must be undergoing evaluation and treatment at City of Hope Cancer Center'}, 'identificationModule': {'nctId': 'NCT04820894', 'briefTitle': 'Perception of Cure Among Patients With Metastatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'City of Hope Medical Center'}, 'officialTitle': 'The Perception of Cure Among Patients With Metastatic Cancer', 'orgStudyIdInfo': {'id': '19322'}, 'secondaryIdInfos': [{'id': 'NCI-2021-01818', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '19322', 'type': 'OTHER', 'domain': 'City of Hope Medical Center'}, {'id': 'P30CA033572', 'link': 'https://reporter.nih.gov/quickSearch/P30CA033572', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational (survey, medical records review)', 'description': "Patients complete surveys over 30 minutes about sociodemographic information and perception of immunotherapy, over 10 minutes about expectations of cure, over 10 minutes about anxiety, over 10 minutes about depression, and over 30 minutes about physical well-being. Patients' medical records are reviewed.", 'interventionNames': ['Other: Electronic Medical Record', 'Other: Survey Administration']}], 'interventions': [{'name': 'Electronic Medical Record', 'type': 'OTHER', 'otherNames': ['Computer Based Patient Record', 'EMR', 'EMR (electronic medical record)'], 'description': 'Medical records are reviewed', 'armGroupLabels': ['Observational (survey, medical records review)']}, {'name': 'Survey Administration', 'type': 'OTHER', 'description': 'Complete surveys', 'armGroupLabels': ['Observational (survey, medical records review)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Sumanta K Pal', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'City of Hope Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'City of Hope Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}