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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03978312
Recruitment Status : Recruiting
First Posted : June 7, 2019
Last Update Posted : June 7, 2019
Sponsor:
Collaborators:
Macmillan Cancer Support
University of Kansas
Bishop Grosseteste University
Newcastle University
Information provided by (Responsible Party):
Nottingham University Hospitals NHS Trust

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.

Condition or disease Intervention/treatment
Cancer Oncologic Disorders Haematological Malignancy Nutrition Aspect of Cancer Other: Nominal consensus group Other: electronic tool completion Other: Patient Survey Other: Friends and Family Survey

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: A survey to measure experiences of getting, using and understanding nutrition information during cancer treatment for patients and their friends or family.

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.

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Study Type : Observational
Estimated Enrollment : 365 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Implications of Nutrition Health Literacy on Accessibility and Engagement With Nutrition Information in Cancer Patients and Their Support Networks
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Literacy


Intervention Details:
  • Other: Nominal consensus group
    Nutrition Health Literacy Measurement Tool adaptation (NLit-UK)
  • Other: electronic tool completion
    Nutrition Health Literacy Measurement Tool validation (NLit-UK)
  • Other: Patient Survey
    Nutrition information cancer patient experience survey
  • Other: Friends and Family Survey
    Nutrition information friend and family of cancer patients experience survey


Primary Outcome Measures :
  1. Nutrition health literacy 2018) [ Time Frame: Dec 2019 ]
    Measured by UK modified NLit (Gibbs et al., 2018) - 64 item questionnaire - On entry to the study (single point reading)

  2. NVS-UK health literacy [ Time Frame: Dec 2019 ]
    Validated tool - 6 part question


Secondary Outcome Measures :
  1. Self-efficacy [ Time Frame: Dec 2019 ]
    AURA 4 part validated questionnaire (Clayman, 2010).

  2. Prior Knowledge [ Time Frame: Dec 2019 ]
    Question about presence or absence of other health illnesses treated or managed with nutrition advice

  3. Perceived confidence in nutrition knowledge and practical nutrition skills [ Time Frame: Dec 2019 ]
    Confidence scales - Completely confident = 5, Very Confident = 4, Somewhat confident = 3, A little confident = 2, Not at all confident, = 1, I have never considered nutrition = 0

  4. Sources of nutrition information [ Time Frame: Dec 2019 ]
    combination of questions (modification of

  5. Confidence in nutrition information from different sources [ Time Frame: Dec 2019 ]
    6 part: confidence scale; Completely confident = 5, Very Confident = 4, Somewhat confident = 3, A little confident = 2, Not at all confident, = 1

  6. Support from health professionals to access nutrition information [ Time Frame: Dec 2019 ]
    11 questions (non-validated)

  7. Food security - US adult food security scale [ Time Frame: Dec 2019 ]
    Validated tool (sections: HH2 to AD5a - with same scoring)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  • Cancer patients
  • Friends or family of cancer patients
  • Members of the public
Criteria

Inclusion and exclusion criteria is dependent on both the project and phase of the study those included or excluded is summarised below. For specific information on each project or phase please contact the lead researcher. All specifics for each component will be included in any publication.

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 19.

Exclusion Criteria:

  • Paediatrics < 18yrs at the time of diagnosis and treatment
  • Unconfirmed diagnosis of cancer
  • Patients on watch and wait

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03978312


Contacts
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Contact: Laura J Miller, MBiol, PGDip 07812 269000 laura.miller@nuh.nhs.uk

Locations
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United Kingdom
Nottingham University Hospitals NHS Trust Recruiting
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
Contact: Laura J Miller, MBiol, PgDip    07812 269000    laura.miller@nuh.nhs.uk   
Sponsors and Collaborators
Nottingham University Hospitals NHS Trust
Macmillan Cancer Support
University of Kansas
Bishop Grosseteste University
Newcastle University
Investigators
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Principal Investigator: Laura J Miller, MBiol, PgDip Nottingham University Hospitals NHS Trust
Publications:
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Responsible Party: Nottingham University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT03978312    
Other Study ID Numbers: 18ON105
First Posted: June 7, 2019    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nottingham University Hospitals NHS Trust:
Nutrition
Health
Literacy
Education
Information
Knowledge
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms
Neoplasms by Site
Hematologic Diseases