Ignite Creation Date:
2025-12-24 @ 12:37 PM
Ignite Modification Date:
2025-12-27 @ 4:06 PM
Study NCT ID:
NCT01827761
Status:
COMPLETED
Last Update Posted:
2022-02-24
First Post:
2013-04-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of the Effectiveness of Chemotherapy Teaching: BrUOG 258
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'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': 196}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-23', 'studyFirstSubmitDate': '2013-04-04', 'studyFirstSubmitQcDate': '2013-04-09', 'lastUpdatePostDateStruct': {'date': '2022-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Evaluate whether chemotherapy teaching sessions improves patient's knowledge, preparedness and anxiety in relation to chemotherapy", 'timeFrame': 'up to 1 month', 'description': "To evaluate whether chemotherapy teaching sessions improves patient's knowledge, preparedness and anxiety in relation to chemotherapy\n\nAfter informed consent for this study is obtained, patients will be given questionnaire #1 that includes rating their knowledge of the side effects of treatment, their understanding of the treatment schedule, what do in the event of complication, how to reach the medical team and an assessment of the level of anxiety. The questionnaire will be repeated at day 1 of the first chemotherapy treatment to assess the effectiveness of the teaching session. In addition, questionnaire #3 will be administered at day 1 of cycle 2 of their first chemotherapy."}], 'secondaryOutcomes': [{'measure': "Compare changes in patient's knowledge, preparedness and anxiety in relation to chemotherapy teaching sessions", 'timeFrame': 'every 6 months up to two years', 'description': "To compare changes in patient's knowledge, preparedness and anxiety in relation to chemotherapy teaching sessions between participating Brown University Oncology Research Group Hospitals After informed consent for this study is obtained, patients will be given questionnaire #1 that includes rating their knowledge of the side effects of treatment, their understanding of the treatment schedule, what do in the event of complication, how to reach the medical team and an assessment of the level of anxiety. The questionnaire will be repeated at day 1 of the first chemotherapy treatment to assess the effectiveness of the teaching session. In addition, questionnaire #3 will be administered at day 1 of cycle 2 of their first chemotherapy."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['chemotherapy teaching', 'questionnaire'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': "This study will evaluate whether chemotherapy teaching sessions improves patient's knowledge, preparedness and anxiety in relation to chemotherapy. This study will also evaluate the effect of age, race, native language, education level, type of cancer and chemotherapy regimen on the oncology teaching session.", 'detailedDescription': "Chemotherapy teaching sessions, often coordinated in the outpatient setting by nursing personnel, are meant to educate patients about the chemotherapy they will be receiving. Education topics include an understanding of side effects, treatment schedule, medications to treat side effects and how to contact the oncology team if adverse events develop. Some of these issues are addressed in the American Society of Clinical Oncology's Quality Oncology Practice Initiative (QOPI). This study will perform an analysis of the teaching process that is provided prior to chemotherapy administration.\n\nThis study will provide data for each participating hospital to individually assess their teaching process. Multivariate analysis can be performed to evaluate whether age, sex, native, language, race highest level of education, cancer type, chemotherapy regimen, institution where chemotherapy will be administered, and type of personnel performing the teaching visit, influences the effectiveness of the teaching visit. In addition, results can be compared across different hospitals.This analysis may lead to improvements in each hospital's chemotherapy teaching practices and lead to advances in patient's cognitive and emotional preparedness."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cancer Clinics', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\> 18 years of age who will be receiving chemotherapy (including targeted anticancer therapy) at a Brown University Oncology Research Group Affiliated Hospital for a period of 1-year after study activation.\n* Patients who will be undergoing a chemotherapy teaching session at an institution affiliated with the Brown University Oncology Research Group.\n* No prior chemotherapy or targeted anticancer treatment.\n* Signed informed consent\n\nExclusion Criteria:\n\nPatients must meet eligibility criteria'}, 'identificationModule': {'nctId': 'NCT01827761', 'briefTitle': 'Assessment of the Effectiveness of Chemotherapy Teaching: BrUOG 258', 'organization': {'class': 'OTHER', 'fullName': 'Brown University'}, 'officialTitle': 'Assessment of the Effectiveness of Chemotherapy Teaching: BrUOG 258', 'orgStudyIdInfo': {'id': '258'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Questionnaire', 'description': 'After informed consent for this study is obtained, patients will be given questionnaire #1 that includes rating their knowledge of the side effects of treatment, their understanding of the treatment schedule, what do in the event of complication, how to reach the medical team and an assessment of the level of anxiety. The questionnaire will be repeated at day 1 of the first chemotherapy treatment to assess the effectiveness of the teaching session. In addition, questionnaire #3 will be administered at day 1 of cycle 2 of their first chemotherapy.', 'interventionNames': ['Behavioral: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'BEHAVIORAL', 'description': 'After informed consent for this study is obtained, patients will be given questionnaire #1 that includes rating their knowledge of the side effects of treatment, their understanding of the treatment schedule, what do in the event of complication, how to reach the medical team and an assessment of the level of anxiety. The questionnaire will be repeated at day 1 of the first chemotherapy treatment to assess the effectiveness of the teaching session. In addition, questionnaire #3 will be administered at day 1 of cycle 2 of their first chemotherapy.', 'armGroupLabels': ['Questionnaire']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02860', 'city': 'Pawtucket', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Memorial Hospital', 'geoPoint': {'lat': 41.87871, 'lon': -71.38256}}, {'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Rhode Island Hospital (including Newport)', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '02906', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'The Miriam Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '02908', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Roger Williams Medical Center', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Anthony Mega, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Brown University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brown University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rhode Island Hospital', 'class': 'OTHER'}, {'name': 'The Miriam Hospital', 'class': 'OTHER'}, {'name': 'Fatima Memorial Hospital', 'class': 'OTHER'}, {'name': 'Roger Williams Medical Center', 'class': 'OTHER'}, {'name': 'Lifespan', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}