Ignite Creation Date:
2025-12-24 @ 2:30 PM
Ignite Modification Date:
2025-12-26 @ 3:46 PM
Study NCT ID:
NCT04927559
Status:
TERMINATED
Last Update Posted:
2024-04-29
First Post:
2021-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Health Literacy in Understanding Radiation Therapy Information in Patients Undergoing Definitive Radiation Therapy
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'whyStopped': 'Low accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-12-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-25', 'studyFirstSubmitDate': '2021-05-25', 'studyFirstSubmitQcDate': '2021-06-08', 'lastUpdatePostDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Understanding of radiation therapy information', 'timeFrame': 'Up to 1 week', 'description': "Patients will be given an internally developed questionnaire of 11 questions intended to ascertain understanding of basic radiotherapy information that is needed to make an informed decision. The questions with one answer will be given a +1 for correct and -1 for incorrect. The questions with multiple answers (toxicity) will be given a +1 for a correctly chosen side effect, and a -1 for an incorrect response. The total will be the patient's summary score."}], 'secondaryOutcomes': [{'measure': 'Radiation comprehension and satisfaction', 'timeFrame': 'Up to 1 week', 'description': 'Findings will be correlated with validated measures of health literacy, acculturation, and socioeconomic status of patients. Will assess variables associated with post-consult knowledge, with independent variables (IVs) comprising of ethnicity, cultural factors (nativity, acculturation), level of health literacy, sex, and socioeconomic status in linear regression models. Bivariate analyses will initially be conducted between IVs and the outcome; variables that are significant at p \\< 0.10 will be included in the multivariable model. Interaction terms will also be examined to test for differences by Hispanic/non-Hispanic ethnicity (the outcome regressed on Hispanic\\*IVs). The alpha level for the multivariable model will be p \\< 0.05.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anatomic Stage I Breast Cancer AJCC v8', 'Anatomic Stage IA Breast Cancer AJCC v8', 'Anatomic Stage IB Breast Cancer AJCC v8', 'Anatomic Stage II Breast Cancer AJCC v8', 'Anatomic Stage IIA Breast Cancer AJCC v8', 'Anatomic Stage IIB Breast Cancer AJCC v8', 'Anatomic Stage III Breast Cancer AJCC v8', 'Anatomic Stage IIIA Breast Cancer AJCC v8', 'Anatomic Stage IIIB Breast Cancer AJCC v8', 'Anatomic Stage IIIC Breast Cancer AJCC v8', 'Prognostic Stage I Breast Cancer AJCC v8', 'Prognostic Stage IA Breast Cancer AJCC v8', 'Prognostic Stage IB Breast Cancer AJCC v8', 'Prognostic Stage II Breast Cancer AJCC v8', 'Prognostic Stage IIA Breast Cancer AJCC v8', 'Prognostic Stage IIB Breast Cancer AJCC v8', 'Prognostic Stage III Breast Cancer AJCC v8', 'Prognostic Stage IIIA Breast Cancer AJCC v8', 'Prognostic Stage IIIB Breast Cancer AJCC v8', 'Prognostic Stage IIIC Breast Cancer AJCC v8', 'Stage I Prostate Cancer AJCC v8', 'Stage II Prostate Cancer AJCC v8', 'Stage IIA Prostate Cancer AJCC v8', 'Stage IIB Prostate Cancer AJCC v8', 'Stage IIC Prostate Cancer AJCC v8', 'Stage III Prostate Cancer AJCC v8', 'Stage IIIA Prostate Cancer AJCC v8', 'Stage IIIB Prostate Cancer AJCC v8', 'Stage IIIC Prostate Cancer AJCC v8', 'Stage IVA Prostate Cancer AJCC v8']}, 'descriptionModule': {'briefSummary': 'This study assesses the health literacy and understanding of radiation therapy information during consultation in patients with prostate or breast cancer undergoing definitive radiation therapy. Health literacy is defined as "the capacity to obtain, process, and understand health information and services to enable sound health decisions." Information gained from this study, may help researchers develop appropriate modalities to enhance comprehension of radiation therapy, and therefore allow for improved patient decision making with medical treatment.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To assess patient health literacy and understanding of critical radiation information during consultation in Spanish and English speaking patient in the department of radiation oncology at Los Angeles County (LAC) + University of Southern California (USC) utilizing a patient survey administered after consultation.\n\nSECONDARY OBJECTIVE:\n\nI. Correlate findings of radiation comprehension and satisfaction with validated measures of health literacy, acculturation, and socioeconomic status of patients.\n\nTERTIARY OBJECTIVE:\n\nI. To assess patient satisfaction of interpreter service in Spanish-speaking patients among breast and prostate cancer patients receiving definitive radiation.\n\nOUTLINE:\n\nPatients complete a survey over 5-10 minutes about their understanding of radiation therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'English and Spanish-speaking patients receiving care through LAC + USC radiation oncology who are being seen in consultation for definitive radiation for breast or prostate cancer.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All participants in this study will have cT1-4N0-1M0 prostate cancer or cT1-4N1-3M0 breast cancer, as clinically staged by the attending radiation oncologist following the American Joint Committee on Cancer (AJCC) 8th edition\n* Non-metastatic breast or prostate cancer\n* Radiation consultation for definitive treatment\n* English or Spanish-speaking\n\nExclusion Criteria:\n\n* Any person with major cognitive deficit or psychiatric impairment\n* Any person, who with assistance by a family member or caregiver, is unable to complete a written survey'}, 'identificationModule': {'nctId': 'NCT04927559', 'briefTitle': 'Health Literacy in Understanding Radiation Therapy Information in Patients Undergoing Definitive Radiation Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern California'}, 'officialTitle': 'Assessing Health Literacy and Interpreter Use in Radiation Oncology at LAC+USC Medical Center', 'orgStudyIdInfo': {'id': '0S-20-6'}, 'secondaryIdInfos': [{'id': 'NCI-2020-06668', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '0S-20-6', 'type': 'OTHER', 'domain': 'USC / Norris Comprehensive Cancer Center'}, {'id': 'P30CA014089', 'link': 'https://reporter.nih.gov/quickSearch/P30CA014089', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational (survey)', 'description': 'Patients complete a survey over 5-10 minutes about their understanding of radiation therapy.', 'interventionNames': ['Other: Survey Administration']}], 'interventions': [{'name': 'Survey Administration', 'type': 'OTHER', 'description': 'Complete survey', 'armGroupLabels': ['Observational (survey)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Los Angeles County-USC Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Kimberly Miller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern California'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern California', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}