Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2026-01-10 @ 6:19 PM
Study NCT ID:
NCT02541266
Status:
COMPLETED
Last Update Posted:
2020-01-28
First Post:
2015-07-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Imaging in Clinical Trials - a Questionnaire Study to Assess Impact of Imaging Regimes on Patient Participation
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': 207}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-27', 'studyFirstSubmitDate': '2015-07-22', 'studyFirstSubmitQcDate': '2015-09-03', 'lastUpdatePostDateStruct': {'date': '2020-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Factors that affect patient participation in imaging research', 'timeFrame': 'Duration of Study - 1 year', 'description': 'Factors about an imaging scan - type, length, frequency or scheduling (timing in relation to treatment) - that are perceived as a significant burden when considering participation in a research study involving imaging.'}], 'secondaryOutcomes': [{'measure': 'Factors affecting participation in the different patient categories', 'timeFrame': 'Duration of Study - 1 year'}, {'measure': 'Effect of current participation in a study on the perceived acceptability of imaging burden', 'timeFrame': 'Duration of Study - 1 year'}, {'measure': 'Do opinions change after undergoing imaging procedures', 'timeFrame': 'Duration of Study - 1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Imaging', 'Questionnaire'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'This research is aimed at finding out what may influence the decision of patients to participate in trials involving imaging so that the investigators may improve our future studies so they are more patient focused and acceptable in regards to scan schedules.', 'detailedDescription': 'This is a questionnaire study aimed at gaining a greater understanding of the patient perspective on undertaking imaging procedures, MRI and PET/CT, for research purposes. The study is to evaluate the patient opinion and perceptions of the burden of imaging associated with research. We will look at different scanning procedures of varying duration, intensity, frequency and scheduling; this will enable us to have a better understand of the factors that influence participation in research and thus help us develop protocols that are more patient focused and acceptable.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Group 1: Patients recruited to studies with imaging Group 2: Patients who have previously participated in studies with imaging Group 3: Patients attending for scans as part of their clinical pathway', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Being treated at The Royal Marsden Hospital\n* Over the age of 18\n* Having imaging (MRI or PET/CT) as part of research or clinical care.\n* Group 1\n\n * Currently enrolled in a research project that involves imaging (either MRI or PET/CT)\n* Group 2\n\n * Previously enrolled in a research project that involved imaging (either MRI or PET/CT), where the patients involvement in the research project has now ended.\n* Group 3\n\n * Patients attending the MRI or PET/CT departments for imaging as part of their standard clinical care.\n\nExclusion Criteria -\n\n* Inability to complete the questionnaire.\n* Previously completed questionnaire.'}, 'identificationModule': {'nctId': 'NCT02541266', 'acronym': 'ASK', 'briefTitle': 'Imaging in Clinical Trials - a Questionnaire Study to Assess Impact of Imaging Regimes on Patient Participation', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Cancer Research, United Kingdom'}, 'officialTitle': 'Imaging in Clinical Trials - a Questionnaire Study to Assess Impact of Imaging Regimes on Patient Participation', 'orgStudyIdInfo': {'id': '15 LO 1189'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Patients currently recruited to studies with imaging at The Marsden', 'interventionNames': ['Other: Questionnaire']}, {'label': 'Group 2', 'description': 'Patients who have previously participated in studies with imaging at The Marsden', 'interventionNames': ['Other: Questionnaire']}, {'label': 'Group 3', 'description': 'Patients attending for scans as part of their clinical pathway', 'interventionNames': ['Other: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': 'A short questionnaire (9 questions) will be given to the participants to complete.', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SM2 5PT', 'city': 'Sutton', 'state': 'Surrey', 'country': 'United Kingdom', 'facility': 'The Royal Marsden NHS Foundation Trust', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Cancer Research, United Kingdom', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute for Health Research, United Kingdom', 'class': 'OTHER_GOV'}, {'name': 'Royal Marsden NHS Foundation Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Translational Imaging', 'investigatorFullName': 'Nandita deSouza', 'investigatorAffiliation': 'Institute of Cancer Research, United Kingdom'}}}}