Nutrition Health Literacy of Cancer Patients and Their Support Networks.

Cancer Clinical Trial

— NiiCproject  

Official title:

Implications of Nutrition Health Literacy on Accessibility and Engagement With Nutrition Information in Cancer Patients and Their Support Networks

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03978312
• Other study ID #: 18ON105
• Status: Terminated
• Start date: September 1, 2019
• Est. completion date: March 31, 2020

Study information

• Verified date: March 2022
• Source: Nottingham University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The study is composed of two component projects:

Project A: Validation of a NLit tool for UK population.

NLit 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.

This project has two phases:

Phase A: Nominal consensus groups x 2 - consumer adaptation and tool review for UK use and pilot testing of electronic tool.

Phase B: Testing adapted tool in a group of cancer patients for statistical validation.

Project B: Planned survey of people with cancer and their families to explore experiences of access to nutrition information

This 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.

It 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 58
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

NLit-UK development

Inclusion Criteria:

• 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

Exclusion Criteria:

• Paediatrics < 18yrs at the time of diagnosis and treatment

• Unconfirmed diagnosis of cancer

• Patients on watch and wait

Related Conditions & MeSH terms

• Cancer
• Haematological Malignancy
• Hematologic Neoplasms
• Nutrition Aspect of Cancer
• Oncologic Disorders

Intervention

Other:
• Nominal consensus group
NLit-UK linguistic and cultural adaptation (NLit-UK) 2 x nominal consensus groups evidence review and topic expert engagement
• Observational cohort (validity and reliability testing)
Nutrition Literacy Measurement Tool validation (NLit-UK). Target sample 366 on treatment cancer patients confirmatory binary analysis for validity and reliability.

Locations

Country	Name	City	State
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham	Nottinghamshire

Sponsors (5)

Lead Sponsor	Collaborator
Nottingham University Hospitals NHS Trust	Bishop Grosseteste University, Macmillan Cancer Support, Newcastle University, University of Kansas

Country where clinical trial is conducted

United Kingdom, 

References & 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Prior Knowledge	Did you receive any nutrition advice as part of your care for any of these conditions?" (Yes or No).	Jun 19 - Mar 2020
Secondary	Educational status (modified HINTS4 Cyc1)	What is the highest grade or level of schooling you completed? GCSE D or less/ GCSE C or above/ Unsure	Jun 19 - Mar 2020
Secondary	Economic status (modified HINTS 2)	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).	Jun 19 - Mar 2020
Secondary	How important did you consider nutrition was in helping you through your treatment?	Response sets: Didn't know enough to consider / Not important ; Moderately Important; Very or extremely important	Jun 19 - Mar 2020