Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-01-13 @ 3:45 AM
Study NCT ID:
NCT03248635
Status:
COMPLETED
Last Update Posted:
2020-04-07
First Post:
2017-08-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Questionnaire Pre-Test Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-04-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-06', 'studyFirstSubmitDate': '2017-08-11', 'studyFirstSubmitQcDate': '2017-08-11', 'lastUpdatePostDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Understanding of the Questionnaire', 'timeFrame': 'Time of Interview', 'description': 'Response errors and comments on interpretation of questions and response categories, and the duration needed to complete the questionnaire modules.'}]}, 'conditionsModule': {'keywords': ['Survey', 'Pre-Test'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'Background:\n\nThe Division of Cancer Epidemiology and Genetics does research into the causes of cancer and ways to prevent it. It uses data from questionnaires. Sometimes, pre-testing a questionnaire with a group of volunteers can help researchers find errors in it and learn ways to improve it.\n\nObjectives:\n\nTo test a questionnaire for problems that might cause response errors and to develop ideas for improving it. To test how long it takes people to complete it.\n\nEligibility:\n\nAdults ages 35-75. Volunteers both with and without a history of tobacco use and with or without a family history of cancer are needed.\n\nDesign:\n\nParticipants will be screened with a phone call.\n\nParticipants will be told what background data to bring to the 1 study visit.\n\nAn interviewer will give the participants the questionnaire. It will be done with pen and paper. It will take about 1 hour.\n\nThere will be multiple-choice and open-ended questions. They will be about lifestyle, medical, and environmental factors. Some of the questions will be about possibly illegal or highly sensitive behaviors.\n\nParticipants will note any questions that they find hard to answer for any reason. They will be asked to answer the best they can, but they can skip any question that they prefer not to answer.\n\nThe personal data of participants will be deleted when the study is done.\n\nThe interviewer will observe participants while they do the questionnaire. He or she will look for things like long pauses and confusion.\n\nParticipants will discuss the exam with the interviewer after they finish. This will take about 1 hour.', 'detailedDescription': 'The mission of the Division of Cancer Epidemiology and Genetics (DCEG) is to conduct broadbased, high quality, high impact research to uncover the causes of cancer and the means of its prevention. To this end, DCEG relies on epidemiologic data captured on self-reported questionnaires. The purpose of this pre-test study is to pilot a questionnaire to: (1) detect problems that might contribute to response errors; (2) develop ideas for improving the questionnaire in order to minimize such errors; and (3) assess the length of time to complete the questionnaire. If there are specific sections of the questionnaire that are skipped by all 30 initial participants, then six (6) additional, separate individuals may be invited to pre-test the questionnaire for sections that were missed by the initial set of participants. After a post-revision of the questionnaire based on the pre-test results, up to 10 additional, separate individuals will be invited to test the revised questionnaire for duration and comprehensibility.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Convenience sample of adult volunteers in geographic proximity to contractor in Durham, NC', 'healthyVolunteers': False, 'eligibilityCriteria': '* ELIGIBILITY CRITERIA:\n* Age 35 to 75\n* Men or women\n* Fluent in English\n* Able to come to the SSS Durham, NC offices for the in-person interview\n* Able to provide informed consent'}, 'identificationModule': {'nctId': 'NCT03248635', 'briefTitle': 'Questionnaire Pre-Test Study', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Online Questionnaire Pre-Test Study', 'orgStudyIdInfo': {'id': '999917139'}, 'secondaryIdInfos': [{'id': '17-C-N139'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Focus group', 'description': 'Male and female adults age 40-75'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27703', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Social & Scientific Systems, INC', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Mark P Purdue, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Institute (NCI)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}