Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-31 @ 4:49 PM
Study NCT ID:
NCT00765869
Status:
UNKNOWN
Last Update Posted:
2008-10-03
First Post:
2008-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomised Controlled Trial of a Literacy Sensitive Decision Aid for Bowel Cancer Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2011-04-13', 'releaseDate': '2011-03-18'}, {'resetDate': '2011-12-01', 'releaseDate': '2011-10-25'}], 'estimatedResultsFirstSubmitDate': '2011-03-18'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 555}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'completionDateStruct': {'date': '2009-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-10-02', 'studyFirstSubmitDate': '2008-10-01', 'studyFirstSubmitQcDate': '2008-10-02', 'lastUpdatePostDateStruct': {'date': '2008-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Informed choice', 'timeFrame': '2 weeks post intervention'}, {'measure': 'Involvement in screening decision', 'timeFrame': '2 weeks post intervention'}], 'secondaryOutcomes': [{'measure': 'Anxiety', 'timeFrame': '2 weeks post intervention'}, {'measure': 'Bowel cancer worry', 'timeFrame': '2 weeks post intervention'}, {'measure': 'Decisional conflict', 'timeFrame': '2 weeks post intervention'}, {'measure': 'Decision satisfaction', 'timeFrame': '2 weeks post intervention'}, {'measure': 'Bowel cancer screening interest', 'timeFrame': '2 weeks post intervention'}, {'measure': 'Bowel cancer screening intentions', 'timeFrame': '2 weeks post intervention'}, {'measure': 'Screening behaviour', 'timeFrame': '2 weeks post intervention'}, {'measure': 'Self reported bowel cancer symptoms', 'timeFrame': '2 weeks post intervention'}, {'measure': 'Evaluation of intervention materials', 'timeFrame': '2 weeks post intervention'}, {'measure': 'Influence of doctor on screening decision', 'timeFrame': '2 weeks post intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Decision support techniques'], 'conditions': ['Colorectal Neoplasms']}, 'referencesModule': {'references': [{'pmid': '18494957', 'type': 'BACKGROUND', 'citation': 'Smith SK, Trevena L, Nutbeam D, Barratt A, McCaffery KJ. Information needs and preferences of low and high literacy consumers for decisions about colorectal cancer screening: utilizing a linguistic model. Health Expect. 2008 Jun;11(2):123-36. doi: 10.1111/j.1369-7625.2008.00489.x.'}, {'pmid': '38284415', 'type': 'DERIVED', 'citation': 'Stacey D, Lewis KB, Smith M, Carley M, Volk R, Douglas EE, Pacheco-Brousseau L, Finderup J, Gunderson J, Barry MJ, Bennett CL, Bravo P, Steffensen K, Gogovor A, Graham ID, Kelly SE, Legare F, Sondergaard H, Thomson R, Trenaman L, Trevena L. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2024 Jan 29;1(1):CD001431. doi: 10.1002/14651858.CD001431.pub6.'}, {'pmid': '20978060', 'type': 'DERIVED', 'citation': 'Smith SK, Trevena L, Simpson JM, Barratt A, Nutbeam D, McCaffery KJ. A decision aid to support informed choices about bowel cancer screening among adults with low education: randomised controlled trial. BMJ. 2010 Oct 26;341:c5370. doi: 10.1136/bmj.c5370.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate a decision aid (written information booklet designed to facilitate informed decision making) to help people aged 55-64 years, with low levels of education and literacy, make an informed choice about bowel cancer screening, using faecal occult blood testing.', 'detailedDescription': "Several countries have recently implemented national bowel cancer screening programs. To ensure equal access to screening, consumer information is needed to suit adults ranging in literacy level. Decision aids (DAs) are tools which have been developed to assist patients and consumers make informed health decisions and encourage active participation in health care decisions. Their use in a wide range of clinical settings has increased dramatically. However, most DAs are highly dependent upon high levels of literacy and numeracy, and few have been developed for low literacy populations.\n\nThis primary aims of this study are to assess the impact of the decision aid on (1) the proportion of adults who make an informed choice about bowel cancer screening (using faecal occult blood test) and, (2) the level of involvement in screening decisions among adults with lower levels of education and literacy.\n\nThere are three secondary aims of the study. First, to measure the effect of the decision support tool on decisional conflict, decision satisfaction, anxiety, and bowel cancer worry. Second, to identify participant's screening interest, intentions and behavior. Thirdly, we will explore participant's reactions towards the information materials they receive and whether the doctor influenced their screening decision."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women aged 55-64 years\n* Lower levels of education\n* English as a main language spoken at home\n* Average risk of bowel cancer\n\nExclusion Criteria:\n\n* Higher levels of education\n* Invitation to take part in bowel cancer screening in last two years\n* Personal or strong family history of bowel cancer\n* Had a bowel cancer screening test in the last two years'}, 'identificationModule': {'nctId': 'NCT00765869', 'briefTitle': 'Randomised Controlled Trial of a Literacy Sensitive Decision Aid for Bowel Cancer Screening', 'organization': {'class': 'OTHER', 'fullName': 'University of Sydney'}, 'officialTitle': 'A Randomised Controlled Trial of a Bowel Cancer Screening Decision Aid for Adults With Low Education and Literacy', 'orgStudyIdInfo': {'id': 'HREC10403'}, 'secondaryIdInfos': [{'id': 'ACTRN12608000011381'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Bowel cancer screening decision aid, DVD and Question Prompt List (QPL)', 'interventionNames': ['Other: Bowel cancer screening decision aid']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Bowel cancer screening decision with DVD only', 'interventionNames': ['Other: Bowel cancer screening decision aid']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'Australian Government Bowel Cancer Screening consumer information booklet', 'interventionNames': ['Other: Australian Government Bowel Cancer Screening booklet']}], 'interventions': [{'name': 'Bowel cancer screening decision aid', 'type': 'OTHER', 'description': 'A decision aid developed for adults with low levels of education and literacy making decisions about bowel cancer screening, using faecal occult blood test (FOBT)', 'armGroupLabels': ['1']}, {'name': 'Bowel cancer screening decision aid', 'type': 'OTHER', 'description': 'A decision aid developed for adults with low levels of education and literacy making decisions about bowel cancer screening, using faecal occult blood test (FOBT)', 'armGroupLabels': ['2']}, {'name': 'Australian Government Bowel Cancer Screening booklet', 'type': 'OTHER', 'description': 'A consumer booklet developed by the Australian Government for people taking part in the National Bowel Cancer Screening program', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2293', 'city': 'Newcastle', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Kirsten J McCaffery, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hunter Valley Research Foundation', 'geoPoint': {'lat': -32.92953, 'lon': 151.7801}}], 'centralContacts': [{'name': 'Kirsten J McCaffery, PhD', 'role': 'CONTACT', 'email': 'kirstenm@health.usyd.edu.au', 'phone': '+61 (0) 2 9351 7220'}, {'name': 'Sian K Smith, BSc (Hons)', 'role': 'CONTACT', 'email': 'sians@health.usyd.edu.au', 'phone': '+61 (0) 2 9351 7220'}], 'overallOfficials': [{'name': 'McCaffery J Kirsten, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sydney'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sydney', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Health and Medical Research Council, Australia', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Dr Kirsten McCaffery', 'oldOrganization': 'Screening and Test Evaluation program,University of Sydney'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2011-03-18', 'type': 'RELEASE'}, {'date': '2011-04-13', 'type': 'RESET'}, {'date': '2011-10-25', 'type': 'RELEASE'}, {'date': '2011-12-01', 'type': 'RESET'}], 'unpostedResponsibleParty': ', A/Prof Kirsten McCaffery, Screening and Test Evaluation program,University of Sydney., University of Sydney'}}}}