Nutrition Health Literacy of Cancer Patients and Their Support Networks. (NiiCproject)

August 17, 2023 updated by: Nottingham University Hospitals NHS Trust

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / 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.

Study Type

Observational

Enrollment (Actual)

58

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
        • Nottingham University Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

  • Cancer patients
  • Friends or family of cancer patients
  • Members of the public

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutrition health literacy - UK
Time Frame: Jun 19 - Mar 2020

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
Time Frame: Jun 19 - Mar 2020

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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nottingham University Hospitals NHS Trust

Collaborators

Newcastle University
University of Kansas
Macmillan Cancer Support
Bishop Grosseteste University

Investigators

  • Principal Investigator: Laura J Miller, MBiol, PgDip, Nottingham University Hospitals NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Actual)

March 31, 2020

Study Completion (Actual)

March 31, 2020

Study Registration Dates

First Submitted

June 5, 2019

First Submitted That Met QC Criteria

June 5, 2019

First Posted (Actual)

June 7, 2019

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 17, 2023

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18ON105

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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