Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-02-22 @ 5:24 PM
Study NCT ID:
NCT00823394
Status:
UNKNOWN
Last Update Posted:
2020-01-27
First Post:
2009-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
African American Cancer Prevention Project: Establishing a Cohort to Investigate Health Disparities
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'}, {'id': 'D001837', 'term': 'Body Weights and Measures'}], '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'}, {'id': 'D001824', 'term': 'Body Constitution'}, {'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D000886', 'term': 'Anthropometry'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2008-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-22', 'studyFirstSubmitDate': '2009-01-14', 'studyFirstSubmitQcDate': '2009-01-14', 'lastUpdatePostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility Study Establishing African American Cancer Prevention Project (AACP)', 'timeFrame': '2 Years', 'description': 'A longitudinal study to learn if and how certain behavioral, social, and environmental factors may affect cancer rates among African Americans as compared to other racial and ethnic groups.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['African American', 'Adults', 'African American Cancer Prevention Project', 'Health Disparities', 'Questionnaire', 'Body Measurements', 'Self-help', 'Cancer Rates', 'Prevention'], 'conditions': ['Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'University of Texas MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': 'The goal of this research study is to learn if certain factors may affect cancer rates among African Americans. These factors include behavioral, social, and environmental factors including diet and physical activity, cigarette smoking, cancer screening, health care, neighborhood environment, and mental health.', 'detailedDescription': "Study Procedures:\n\nIf you decide to take part in this study, you will complete study procedures at month 36 (the day you sign this consent form) and again every year for the next 2 years. These procedures include completing a questionnaire, having your body measurements taken, and receiving self-help materials.\n\nAt month 36, you will complete the questionnaire on a computer that is set up at the church in a private room. The questions will be about nutrition, exercise, tobacco and alcohol use, your neighborhood, age, education, social status, health status, stress, and racism. It should take about 75 minutes to complete. Your waist, hip, height, and weight will also be measured while you are in the private room.\n\nEvery year after that for the next 2 years, you will go back to the church to complete a new questionnaire each time. The questionnaires should take about 75 minutes to complete each time.\n\nIf you cannot get back to the church, you may complete the questionnaire over the phone. The study staff will provide you with the phone number and directions on how to complete the survey over the phone. Your measurements will be taken at the church, or at the Behavioral Research and Treatment Center (BRTC) at MD Anderson, whichever is more convenient for you.\n\nAt each study visit, you will also receive self-help materials on how to lower your risk for developing cancer.\n\nQuestionnaire Data:\n\nYour questionnaire data will be used for research purposes only. Your responses will not be shared with your personal doctor. If you feel you need a doctor's opinion about anything that is asked about in the questionnaire (such as mental or emotional difficulties or symptoms), please contact your personal physician.\n\nAbout 1 month after each you complete the questionnaire each time, the research staff will review and score your responses. If your scores suggest signs of depression, you will be given a list of resources for mental health screening.\n\nLength of Study:\n\nAfter 5 years, your active participation in this study will be over. You may be contacted in the future to see if you would agree to take part in other research studies.\n\nThis is an investigational study.\n\nUp to 1,501 people will take part in this study. All will be enrolled at MD Anderson."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult attendees of Windsor Village United Methodist Church living in Houston.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. be age 18 years old and above\n2. read and write English\n3. live in the Houston metro area\n4. have a viable (working) telephone number and home address\n\nExclusion Criteria:\n\n1\\) None.'}, 'identificationModule': {'nctId': 'NCT00823394', 'briefTitle': 'African American Cancer Prevention Project: Establishing a Cohort to Investigate Health Disparities', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'African American Cancer Prevention Project: Establishing a Cohort to Investigate Health Disparities', 'orgStudyIdInfo': {'id': '2007-0970'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Windsor Village United Methodist Church', 'description': 'Questionnaire + Body Measurements + Self-help Materials', 'interventionNames': ['Behavioral: Questionnaire', 'Other: Body Measurements', 'Behavioral: Self-help Materials']}], 'interventions': [{'name': 'Questionnaire', 'type': 'BEHAVIORAL', 'otherNames': ['Survey'], 'description': 'Completed privately via computer at Windsor Village Church, approximately 75 minutes. Repeated at Months 12 and 24.', 'armGroupLabels': ['Windsor Village United Methodist Church']}, {'name': 'Body Measurements', 'type': 'OTHER', 'description': 'Waist, hip, height, and weight measured privately. Repeated at Months 12 and 24.', 'armGroupLabels': ['Windsor Village United Methodist Church']}, {'name': 'Self-help Materials', 'type': 'BEHAVIORAL', 'description': 'Information on how to lower risk for developing cancer.', 'armGroupLabels': ['Windsor Village United Methodist Church']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Lorna H. McNeill, MPH, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}