NLit and Outcomes in HNC Survivor-Caregiver Dyads

Recruiting

• Conditions: Caregiver Burden; Health Knowledge, Attitudes, Practice; Head and Neck Cancer

• Registration Number: NCT07021885
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-01
• Study First Submitted: 2025-05-29
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-11
• Last Update Submitted: 2025-06-11
• Study First Posted: 2025-06-15
• Last Update Posted: 2025-06-15
• Primary Completion: 2025-08-16
• Study Completion: 2026-05-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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
• Prisoners

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Nutrition Literacy	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	at a single time point between 6 months and 5 years post-treatment	Measured by the Mini Nutrition Assessment (MNA)
Skin Carotenoid	at a single time point between 6 months and 5 years post-treatment	Using the Veggie Meter®
Functional status	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.	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	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	at a single time point between 6 months and 5 years post-treatment	Assessed using a modified Godin Leisure-Time Exercise Questionnaire
Food Security	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	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	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	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
Body composition	at a single time point between 6 months and 5 years post-treatment	Measured by BIA - InBody© 270, USA

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States