Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2026-03-01 @ 3:17 AM
Study NCT ID:
NCT03978312
Status:
TERMINATED
Last Update Posted:
2023-08-21
First Post:
2019-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutrition Health Literacy of Cancer Patients and Their Support Networks.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D000067010', 'term': 'Literacy'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D003142', 'term': 'Communication'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Recruitment was due to be extended (March 20) due to slow initial recruitment however was terminated early due to corresponding arrival of COVID-19 to UK. (16 recruited to cultural and linguistic phase and 42 to observational cohort)', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-17', 'studyFirstSubmitDate': '2019-06-05', 'studyFirstSubmitQcDate': '2019-06-05', 'lastUpdatePostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nutrition health literacy - UK', 'timeFrame': 'Jun 19 - Mar 2020', 'description': 'Measured by UK modified NLit developed during study cultural and linguistic modification of (Gibbs et al., 2018 - original validation) - 64 item questionnaire\n\nScoring interpretation from study: NLit-UK (63item) and NLit-UK short (42-item) NLit-UK (63-item): Scoring interpretation is ≤44 correct is "likelihood of poor nutrition literacy"; 45-57 is "possibility of poor nutrition literacy"; and scores ≥58 is "likelihood of good nutrition literacy\n\nNLit-UK short (42-item): Scoring interpretation is ≤28 correct is "likelihood of poor nutrition literacy"; 29-37 is "possibility of poor nutrition literacy"; and scores ≥39 is "likelihood of good nutrition literacy'}, {'measure': 'NVS-UK health literacy', 'timeFrame': 'Jun 19 - Mar 2020', 'description': 'Validated tool - 6 part question (Rowlands et al, 2013)\n\nScoring interpretation: low health literacy (≤1), intermediate health literacy (2-3), adequate health literacy (≥4).'}], 'secondaryOutcomes': [{'measure': 'Prior Knowledge', 'timeFrame': 'Jun 19 - Mar 2020', 'description': 'Did you receive any nutrition advice as part of your care for any of these conditions?" (Yes or No).'}, {'measure': 'Educational status (modified HINTS4 Cyc1)', 'timeFrame': 'Jun 19 - Mar 2020', 'description': 'What is the highest grade or level of schooling you completed? GCSE D or less/ GCSE C or above/ Unsure'}, {'measure': 'Economic status (modified HINTS 2)', 'timeFrame': 'Jun 19 - Mar 2020', 'description': 'At the end of the month, how much money are you able to put aside? (Nothing, £100 or less, £101-250, £251-500, £501-1000, more than £1000, do not want to say).'}, {'measure': 'How important did you consider nutrition was in helping you through your treatment?', 'timeFrame': 'Jun 19 - Mar 2020', 'description': "Response sets: Didn't know enough to consider / Not important ; Moderately Important; Very or extremely important"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nutrition', 'Health', 'Literacy', 'Education', 'Information', 'Knowledge'], 'conditions': ['Cancer', 'Oncologic Disorders', 'Haematological Malignancy', 'Nutrition Aspect of Cancer']}, 'referencesModule': {'references': [{'pmid': '25952941', 'type': 'BACKGROUND', 'citation': 'Gibbs HD, Ellerbeck EF, Befort C, Gajewski B, Kennett AR, Yu Q, Christifano D, Sullivan DK. Measuring Nutrition Literacy in Breast Cancer Patients: Development of a Novel Instrument. J Cancer Educ. 2016 Sep;31(3):493-9. doi: 10.1007/s13187-015-0851-y.'}, {'pmid': '29246567', 'type': 'BACKGROUND', 'citation': 'Gibbs HD, Ellerbeck EF, Gajewski B, Zhang C, Sullivan DK. The Nutrition Literacy Assessment Instrument is a Valid and Reliable Measure of Nutrition Literacy in Adults with Chronic Disease. J Nutr Educ Behav. 2018 Mar;50(3):247-257.e1. doi: 10.1016/j.jneb.2017.10.008. Epub 2017 Dec 12.'}, {'pmid': '28890794', 'type': 'BACKGROUND', 'citation': 'Gibbs HD, Harvey S, Owens S, Boyle D, Sullivan DK. Engaging Experts and Patients to Refine the Nutrition Literacy Assessment Instrument. BMC Nutr. 2017;3:71. doi: 10.1186/s40795-017-0190-y. Epub 2017 Aug 22.'}]}, 'descriptionModule': {'briefSummary': 'An exploration of the impact of nutrition literacy on ability of cancer patients and their support networks to get, understand and use nutrition information during cancer treatment.', 'detailedDescription': 'The study is composed of two component projects:\n\nProject A: Validation of a NLit tool for UK population.\n\nNLit tool is a measurement tool developed at Kansas University to measure nutrition health literacy. It assesses the following functional literacy skills: numeracy \\& literacy and the following nutrition knowledge fields: macronutrients, food labels, portion sizes, food groups and consumer skills.\n\nThis project has two phases:\n\nPhase A: Nominal consensus groups x 2 - consumer adaptation and tool review for UK use and pilot testing of electronic tool.\n\nPhase B: Testing adapted tool in a group of cancer patients for statistical validation.\n\nProject B: Planned survey of people with cancer and their families to explore experiences of access to nutrition information\n\nThis survey is a combination of validated and unvalidated questions built on models of nutrition health literacy. With validated fields being used to evaluate and understand responses to unvalidated questions.\n\nIt explores access to nutrition information, self-efficacy, confidence, health care infrastructure and support with nutrition information, population demographics, food security, sources of nutrition information, perceived practical skills and knowledge base.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* Cancer patients\n* Friends or family of cancer patients\n* Members of the public', 'healthyVolunteers': False, 'eligibilityCriteria': 'NLit-UK development\n\nInclusion Criteria:\n\n* Members of the public (carers, health service users, lay persons)\n* Cancer patients with confirmed diagnosis\n* Friends or family members supporting a patient with a confirmed diagnosis of cancer\n* \\> 18 yrs old\n* Received cancer treatment at Nottingham University Hospitals between Jan 15 and March 20\n\nExclusion Criteria:\n\n* Paediatrics \\< 18yrs at the time of diagnosis and treatment\n* Unconfirmed diagnosis of cancer\n* Patients on watch and wait'}, 'identificationModule': {'nctId': 'NCT03978312', 'acronym': 'NiiCproject', 'briefTitle': 'Nutrition Health Literacy of Cancer Patients and Their Support Networks.', 'organization': {'class': 'OTHER', 'fullName': 'Nottingham University Hospitals NHS Trust'}, 'officialTitle': 'Implications of Nutrition Health Literacy on Accessibility and Engagement With Nutrition Information in Cancer Patients and Their Support Networks', 'orgStudyIdInfo': {'id': '18ON105'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Nominal consensus group', 'type': 'OTHER', 'description': 'NLit-UK linguistic and cultural adaptation (NLit-UK) 2 x nominal consensus groups evidence review and topic expert engagement'}, {'name': 'Observational cohort (validity and reliability testing)', 'type': 'OTHER', 'description': 'Nutrition Literacy Measurement Tool validation (NLit-UK). Target sample 366 on treatment cancer patients confirmatory binary analysis for validity and reliability.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NG5 1PB', 'city': 'Nottingham', 'state': 'Nottinghamshire', 'country': 'United Kingdom', 'facility': 'Nottingham University Hospitals NHS Trust', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'overallOfficials': [{'name': 'Laura J Miller, MBiol, PgDip', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nottingham University Hospitals NHS Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nottingham University Hospitals NHS Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'Macmillan Cancer Support', 'class': 'OTHER'}, {'name': 'University of Kansas', 'class': 'OTHER'}, {'name': 'Bishop Grosseteste University', 'class': 'UNKNOWN'}, {'name': 'Newcastle University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}