NLit and Outcomes in HNC Survivor-Caregiver Dyads
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Kansas Medical Center
About this trial
The goal of this observational (cross-sectional) study is to better understand nutrition literacy in survivor-caregiver dyads and its impact on nutrition related outcomes and quality of life. We're interested in finding out how much they know about nutrition and how this might relate to their overall health, body composition, functional status, and overall well-being. We will target post-treatment head and neck cancer survivors and a paired informal caregiver.
The main questions we aim to answer are:
* How does the nutrition literacy of both the survivor and caregiver relate to their sociodemographic, behavioral, and clinical characteristics? * How dyadic nutrition literacy influence individual nutrition outcomes like skin carotenoid levels, body composition, and functional status? * Does the shared nutrition knowledge (nutrition literacy) of both the survivor and caregiver impact their quality of life together?
Participants will:
Answer questions about their knowledge of nutrition. Have their nutritional health status checked. Use a non-invasive device to measure skin carotenoid content to validate self-reports of fruit and vegetable intake.
Have a simple and painless test to measure their body composition - like how much muscle and fat they have.
Do some physical tests like grip strength and walking to measure their physical ability.
Answer questions about their general well-being and lifestyle, like exercise and diet.
(For the survivor) Share details about their cancer, its treatment, and their overall well-being.
(For the caregiver) Answer questions about their role in taking care of the survivor, and their involvement in care routine such as food shopping and cooking.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Survivors and their caregivers will be eligible to participate if the survivor 1) has a history of oral cavity, pharyngeal, or laryngeal cancer, 2) is between 6 months - 4 years post-primary oncology treatment, 3) has no evidence of disease, 4) has an informal caregiver living in or out of the home who has a shared or primary role in food procurement and/or preparation, 5) no current use of feeding tube as the primary source of nutrition and can consume food orally, 6) age 18+, 7) English-speaking. Survivors and their caregivers will not be eligible to participate if either has 1) dementia or organic brain syndrome; 2) severe emotional distress; 3) active schizophrenia, 4) another diagnosis of cancer in the past five years (not including skin or cervical cancer in situ).
Disqualifiers
Adults unable to consent
Individuals who are not yet adults (infants, children, teenagers)
Pregnant women
Prisoners
Trial population
post-treatment head and neck cancer survivors and a paired informal caregiver
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Nutrition Literacy
Measured by the self-administered Nutrition Literacy Assessment Instrument (NLit).
Time frame
at a single time point between 6 months and 5 years post-treatment2
Nutrition Status
Measured by the Mini Nutrition Assessment (MNA)
Time frame
at a single time point between 6 months and 5 years post-treatment3
Skin Carotenoid
Using the Veggie Meter®
Time frame
at a single time point between 6 months and 5 years post-treatment4
Body composition
Measured by BIA - InBody© 270, USA
Time frame
at a single time point between 6 months and 5 years post-treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov