Clinical trial NCT03978312: Nutrition Health Literacy of Cancer Patients and Their Support Networks.
Official title: Implications of Nutrition Health Literacy on Accessibility and Engagement With Nutrition Information in Cancer Patients and Their Support Networks
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cancer
Oncologic Disorders
Haematological Malignancy
Nutrition Aspect of Cancer
Keywords: Nutrition
Health
Literacy
Education
Information
Knowledge
Lead sponsor: Nottingham University Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: Macmillan Cancer Support
name: University of Kansas
name: Bishop Grosseteste University
name: Newcastle University
First posted: 2019-06-07
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Cancer patients
* Friends or family of cancer patients
* Members of the public

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Nutrition health literacy - UK
timeFrame: Jun 19 - Mar 2020
measure: NVS-UK health literacy
timeFrame: Jun 19 - Mar 2020
Secondary outcomes:
measure: Prior Knowledge
timeFrame: Jun 19 - Mar 2020
measure: Educational status (modified HINTS4 Cyc1)
timeFrame: Jun 19 - Mar 2020
measure: Economic status (modified HINTS 2)
timeFrame: Jun 19 - Mar 2020
measure: How important did you consider nutrition was in helping you through your treatment?
timeFrame: Jun 19 - Mar 2020
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
state: Nottinghamshire
Study officials:
affiliation: Nottingham University Hospitals NHS Trust
name: Laura J Miller, MBiol, PgDip
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.