Clinical trial NCT07021885: NLit and Outcomes in HNC Survivor-Caregiver Dyads
Official title: Nutrition Literacy and Associated Outcomes in Head and Neck Cancer Survivor-caregiver Dyads
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head and Neck Cancer
Caregiver Burden
Health Knowledge, Attitudes, Practice
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2025-06-15
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: post-treatment head and neck cancer survivors and a paired informal caregiver

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.


Eligibility criteria: 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

Primary outcomes:
measure: Nutrition Literacy
timeFrame: at a single time point between 6 months and 5 years post-treatment
measure: Nutrition Status
timeFrame: at a single time point between 6 months and 5 years post-treatment
measure: Skin Carotenoid
timeFrame: at a single time point between 6 months and 5 years post-treatment
measure: Body composition
timeFrame: at a single time point between 6 months and 5 years post-treatment
measure: Functional status
timeFrame: at a single time point between 6 months and 5 years post-treatment
measure: Sociodemographics.
timeFrame: at a single time point between 6 months and 5 years post-treatment
measure: Fruit & Vegetable Intake
timeFrame: at a single time point between 6 months and 5 years post-treatment
measure: Exercise
timeFrame: at a single time point between 6 months and 5 years post-treatment
measure: Food Security
timeFrame: At a single time point between 6 months and 5 years post-treatment
measure: Caregiving characteristics
timeFrame: between 6 months and 5 years post-treatment
measure: Quality of life
timeFrame: between 6 months and 5 years post-treatment
measure: Clinical characteristics
timeFrame: between 6 months and 5 years post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
References: