Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-01-03 @ 6:30 AM
Study NCT ID:
NCT03207594
Status:
COMPLETED
Last Update Posted:
2025-01-31
First Post:
2017-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Evidence-Based Care for Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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'}, {'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': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, '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': 128}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-29', 'studyFirstSubmitDate': '2017-03-22', 'studyFirstSubmitQcDate': '2017-06-30', 'lastUpdatePostDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with biochemically confirmed smoking cessation', 'timeFrame': '4 weeks after enrollment', 'description': 'Biochemical confirmation will be determined by saliva samples'}, {'measure': 'Number of patient who self-report smoking cessation', 'timeFrame': '4 weeks after enrollment', 'description': 'Self-reported smoking cessation will be documented via smoking assessment questionnaire'}], 'secondaryOutcomes': [{'measure': 'Average weekly smoke exposure', 'timeFrame': 'up to 62 weeks', 'description': 'reported cigarettes per day multiplied by the number of days smoked during radiation therapy (RT), summed over a period of time and normalized to yield an average weekly smoke exposure during RT.'}, {'measure': 'Number of patients who participate in smoking cessation', 'timeFrame': 'up to 12 months after completion of RT.', 'description': 'Completing one in-person visit where an individualized smoking cessation treatment plan is developed and implemented.'}, {'measure': 'Compliance with smoking cessation', 'timeFrame': 'up to 12 weeks after completion of RT', 'description': 'Two binary measure of compliance:\n\n1. \\- completing at least three in person visits within 6 weeks of starting an individualized cessation treatment plan\n2. \\- completing at least one in-person visit and at least two phone-based communications'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Head and Neck Cancer', 'Prostate Cancer', 'Breast Cancer', 'Lung Cancer', 'Gynecologic Cancer', 'Gastrointestinal Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to improve cancer care and the delivery of cancer care. Researchers are interested in studying patient reported information and examining how different factors may impact cancer care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient who have been diagnosed with head/neck, lung, breast, prostate, gastrointestinal or gynecologic cancers that are 21 years of age or older. Patients must have been referred to MUSC radiation oncology for treatment with curative radiation therapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with head/neck, lung, breast, prostate, gastrointestinal or gynecologic cancer\n* 21 years of age or older at time of study registration\n* Must have been referred to MUSC radiation oncology for treatment with curative radiation therapy\n* Must report current smoking defined as self-reporting smoking within the past 30 days using a structured intake questionnaire.\n\nExclusion Criteria:\n\n* Patients with primary central nervous system malignancies will be excluded.\n* Patients that have other cancer disease types will be excluded due to either significant differences in standard radiation therapy approaches or rarity of disease required radiation.\n* Patients who are currently participating in the Medical University of South Carolina Hollings Cancer Center smoking cessation program\n* Patients who are unable to provide informed consent'}, 'identificationModule': {'nctId': 'NCT03207594', 'briefTitle': 'Improving Evidence-Based Care for Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'Improving Evidence-Based Care for Cancer Patients', 'orgStudyIdInfo': {'id': '102472'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Arm 1', 'description': 'Current smokers with cancer who are planning to get radiation therapy at MUSC.', 'interventionNames': ['Other: Survey', 'Other: Saliva sample', 'Other: Smoking Status questions']}], 'interventions': [{'name': 'Survey', 'type': 'OTHER', 'description': 'Subjects will be asked to complete a survey asking questions about his/her current health, well-being and quality of life.', 'armGroupLabels': ['Arm 1']}, {'name': 'Saliva sample', 'type': 'OTHER', 'description': 'Subjects will have saliva collected by a member of the study team using a cotton swab.', 'armGroupLabels': ['Arm 1']}, {'name': 'Smoking Status questions', 'type': 'OTHER', 'description': 'Subjects will be asked to complete an assessment asking questions about his/her current smoking status', 'armGroupLabels': ['Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'overallOfficials': [{'name': 'Graham Warren, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}