Recruiting

Nutrition Literacy

Sponsor:

University of Kansas Medical Center

Code:

NCT07021885

Conditions

Head and Neck Cancer

Caregiver Burden

Health Knowledge, Attitudes, Practice

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Head and Neck Cancer

Caregiver Burden

Health Knowledge, Attitudes, Practice

Study ID

NCT07021885

Start date

Dec 1, 2023

Status verified date

Jun, 2025

Completion date

May 16, 2026

Anticipated

Primary completion date

Aug 16, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Nutrition Literacy [ Time Frame: at a single time point between 6 months and 5 years post-treatment ]
  • Nutrition Status [ Time Frame: at a single time point between 6 months and 5 years post-treatment ]
  • Skin Carotenoid [ Time Frame: at a single time point between 6 months and 5 years post-treatment ]
  • Body composition [ Time Frame: at a single time point between 6 months and 5 years post-treatment ]
  • Functional status [ Time Frame: at a single time point between 6 months and 5 years post-treatment ]
  • Sociodemographics. [ Time Frame: at a single time point between 6 months and 5 years post-treatment ]
  • Fruit & Vegetable Intake [ Time Frame: at a single time point between 6 months and 5 years post-treatment ]
  • Exercise [ Time Frame: at a single time point between 6 months and 5 years post-treatment ]
  • Food Security [ Time Frame: At a single time point between 6 months and 5 years post-treatment ]
  • Caregiving characteristics [ Time Frame: between 6 months and 5 years post-treatment ]
  • Quality of life [ Time Frame: between 6 months and 5 years post-treatment ]
  • Clinical characteristics [ Time Frame: between 6 months and 5 years post-treatment ]

Central Contacts and Locations

Locations

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Anna Arthur

913-945-7079aarthur4@kumc.edu

More Information

Sponsor

University of Kansas Medical Center

Last update posted

Jun 15, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2025-06-15.