Study Stopped
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)
Nutrition Health Literacy of Cancer Patients and Their Support Networks.
NiiCproject
Implications of Nutrition Health Literacy on Accessibility and Engagement With Nutrition Information in Cancer Patients and Their Support Networks
1 other identifier
observational
58
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2019
CompletedFirst Posted
Study publicly available on registry
June 7, 2019
CompletedStudy Start
First participant enrolled
September 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2020
CompletedAugust 21, 2023
March 1, 2022
7 months
June 5, 2019
August 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Nutrition health literacy - UK
Measured by UK modified NLit developed during study cultural and linguistic modification of (Gibbs et al., 2018 - original validation) - 64 item questionnaire Scoring 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 NLit-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
Jun 19 - Mar 2020
NVS-UK health literacy
Validated tool - 6 part question (Rowlands et al, 2013) Scoring interpretation: low health literacy (≤1), intermediate health literacy (2-3), adequate health literacy (≥4).
Jun 19 - Mar 2020
Secondary Outcomes (4)
Prior Knowledge
Jun 19 - Mar 2020
Educational status (modified HINTS4 Cyc1)
Jun 19 - Mar 2020
Economic status (modified HINTS 2)
Jun 19 - Mar 2020
How important did you consider nutrition was in helping you through your treatment?
Jun 19 - Mar 2020
Interventions
NLit-UK linguistic and cultural adaptation (NLit-UK) 2 x nominal consensus groups evidence review and topic expert engagement
Nutrition Literacy Measurement Tool validation (NLit-UK). Target sample 366 on treatment cancer patients confirmatory binary analysis for validity and reliability.
Eligibility Criteria
* Cancer patients * Friends or family of cancer patients * Members of the public
You may qualify if:
- Members of the public (carers, health service users, lay persons)
- Cancer patients with confirmed diagnosis
- Friends or family members supporting a patient with a confirmed diagnosis of cancer
- \> 18 yrs old
- Received cancer treatment at Nottingham University Hospitals between Jan 15 and March 20
You may not qualify if:
- Paediatrics \< 18yrs at the time of diagnosis and treatment
- Unconfirmed diagnosis of cancer
- Patients on watch and wait
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nottingham University Hospitals NHS Trustlead
- Macmillan Cancer Supportcollaborator
- University of Kansascollaborator
- Bishop Grosseteste Universitycollaborator
- Newcastle Universitycollaborator
Study Sites (1)
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, NG5 1PB, United Kingdom
Related Publications (3)
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: 25952941BACKGROUNDGibbs 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: 29246567BACKGROUNDGibbs 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.
PMID: 28890794BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laura J Miller, MBiol, PgDip
Nottingham University Hospitals NHS Trust
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2019
First Posted
June 7, 2019
Study Start
September 1, 2019
Primary Completion
March 31, 2020
Study Completion
March 31, 2020
Last Updated
August 21, 2023
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share