NCT07021885 · University of Kansas Medical Center
NLit and Outcomes in HNC Survivor-Caregiver Dyads
What this study is about
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.
View original scientific description
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.
Primary outcome measures
Nutrition Literacy
Time frame: at a single time point between 6 months and 5 years post-treatment
Measured by the self-administered Nutrition Literacy Assessment Instrument (NLit).
Nutrition Status
Time frame: at a single time point between 6 months and 5 years post-treatment
Measured by the Mini Nutrition Assessment (MNA)
Skin Carotenoid
Time frame: at a single time point between 6 months and 5 years post-treatment
Using the Veggie Meter®
Body composition
Time frame: at a single time point between 6 months and 5 years post-treatment
Measured by BIA - InBody© 270, USA
Functional status
Time frame: at a single time point between 6 months and 5 years post-treatment
Handgrip strength will be measured and recorded 3 times using the Jamar hand dynamometer on the dominant hand; Functional performance status will also be assessed using a short physical performance battery consisting of three functional tests assessing performance.
Sociodemographics.
Time frame: at a single time point between 6 months and 5 years post-treatment
Age, biological sex, race, ethnicity, years of education, annual household income, employment status, pack-years smoking, alcohol consumption (current, former, never) will be self-reported.
Fruit & Vegetable Intake
Time frame: at a single time point between 6 months and 5 years post-treatment
Using the Eating at America's Table Study's (EATS) All-Day screener designed, and validated by the National Cancer Institute
Exercise
Time frame: at a single time point between 6 months and 5 years post-treatment
Assessed using a modified Godin Leisure-Time Exercise Questionnaire
Food Security
Time frame: At a single time point between 6 months and 5 years post-treatment
Self-reported food security will be assessed using the USDA's U.S. Household Food Security Survey Module: Six-Item Short Form
Caregiving characteristics
Time frame: between 6 months and 5 years post-treatment
Caregiver only: Caregivers will be asked to self-report their residence (in or out of survivor's home), years spent caregiving, hours per week spent caregiving, relationship to survivor, and role in food procurement and preparation
Quality of life
Time frame: between 6 months and 5 years post-treatment
Caregiver: Overall quality of life will be assessed using the Caregiver FACT-General, which is structured and scored similarly to the FACT-HN but adapted for use in cancer caregivers. Cancer survivor: Overall quality of life will be assess using the Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN) quality of life questionnaire.
Clinical characteristics
Time frame: between 6 months and 5 years post-treatment
Tumor site, cancer stage, treatment modality, and HPV-status of the tumor will be collected through EMR review
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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).
Exclusion criteria
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
Where
- Kansas City, Kansas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 15, 2025 · Source of record for eligibility and locations