NLit and Outcomes in HNC Survivor-Caregiver Dyads

NCT ID: NCT07021885

Last Updated: 2025-06-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2026-05-16

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 Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Anna Arthur

Role: primary

aarthur4@kumc.edu

913-945-7079

Other Identifiers

COE Pilot 2023

Identifier Type: -

Identifier Source: org_study_id