CancerNiiCprojectNCT03978312
Nutrition Health Literacy of Cancer Patients and Their Support Networks.
An observational study of Cancer and Oncologic Disorders, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Oncologic Disorders, Haematological Malignancy
- What is being tested?
- Nominal consensus group and Observational cohort (validity and reliability testing)
- How many people
- 58 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2019to 31 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Cancer patients * Friends or family of cancer patients * Members of the public
Who may be able to join
- 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
Who cannot join
- Paediatrics < 18yrs at the time of diagnosis and treatment
- Unconfirmed diagnosis of cancer
- Patients on watch and wait
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, NG5 1PB
About this study
Official title: 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.
Read the 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.
- Being tested
- Nominal consensus group, Observational cohort (validity and reliability testing)
- Keywords
- Nutrition, Health, Literacy, Education, Information, Knowledge
- Medical subject headings
- Neoplasms, Hematologic Neoplasms, Literacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nominal consensus groupOther
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)Other
Nutrition Literacy Measurement Tool validation (NLit-UK). Target sample 366 on treatment cancer patients confirmatory binary analysis for validity and reliability.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: Jun 19 - Mar 2020
Secondary outcomes (4)
Prior Knowledge
Did you receive any nutrition advice as part of your care for any of these conditions?" (Yes or No).
Measured: Jun 19 - Mar 2020
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
Measured: Jun 19 - Mar 2020
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).
Measured: Jun 19 - Mar 2020
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
Measured: Jun 19 - Mar 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start1 Sep 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Why it 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)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Macmillan Cancer Support, University of Kansas, Bishop Grosseteste University, Newcastle University
- Responsible party
- Sponsor
- Investigators
- Laura J Miller, MBiol, PgDip, Principal investigator, Nottingham University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03978312
- Sponsor's protocol ID
- 18ON105
- Acronym
- NiiCproject
- Status last verified
- Mar 2022
- First submitted
- 5 Jun 2019
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25952941Gibbs 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.
PubMed 29246567Gibbs 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.
PubMed 28890794Miller LJ, Postavaru GI, Rowlands G, Prior M, Webb Z, Wragg A, Gibbs HD. Cultural and Linguistic Adaptation and Validation of a Nutrition Literacy Instrument for Use in People With Cancer in the United Kingdom. J Hum Nutr Diet. 2026 Apr;39(2):e70218. doi: 10.1111/jhn.70218.
PubMed 41808418
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implications of Nutrition Health Literacy on Accessibility and Engagement With Nutrition Information in Cancer Patients and Their Support Networks
- ClinicalTrials.gov ID
- NCT03978312
- Acronym / sponsor ID
- NiiCproject / 18ON105
- Keywords
- Nutrition, Health, Literacy, Education, Information, Knowledge
- Study type
- Observational
- Recruitment status
- TerminatedReason 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)
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- Macmillan Cancer Support, University of Kansas, Bishop Grosseteste University, Newcastle University
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 7 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Cancer patients * Friends or family of cancer patients * Members of the public
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Paediatrics < 18yrs at the time of diagnosis and treatment
- Unconfirmed diagnosis of cancer
- Patients on watch and wait
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nominal consensus groupNLit-UK linguistic and cultural adaptation (NLit-UK) 2 x nominal consensus groups evidence review and topic expert engagement | Other | – |
| 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. | Other | – |
Primary outcome
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
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).
4 secondary outcomes
Prior Knowledge
Time frame: Jun 19 - Mar 2020
Educational status (modified HINTS4 Cyc1)
Time frame: Jun 19 - Mar 2020
Economic status (modified HINTS 2)
Time frame: Jun 19 - Mar 2020
How important did you consider nutrition was in helping you through your treatment?
Time frame: Jun 19 - Mar 2020
Results and safety
The study was stopped early (reason given: 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)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Background: PubMed 25952941Gibbs 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.
- Background: PubMed 29246567Gibbs 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.
- Background: PubMed 28890794Gibbs 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.
- Derived from this study: PubMed 41808418Miller LJ, Postavaru GI, Rowlands G, Prior M, Webb Z, Wragg A, Gibbs HD. Cultural and Linguistic Adaptation and Validation of a Nutrition Literacy Instrument for Use in People With Cancer in the United Kingdom. J Hum Nutr Diet. 2026 Apr;39(2):e70218. doi: 10.1111/jhn.70218.
- Individual participant dataSharing planned: No
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura J Miller, MBiol, PgDip principal investigator
Nottingham University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Oncologic Disorders, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutrition health literacy - UK (time frame: Jun 19 - Mar 2020). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03978312, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.