NLit and Outcomes in HNC Survivor-Caregiver Dyads
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Head and Neck Cancer, Caregiver Burden, Health Knowledge, Attitudes, Practice. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Nutrition Literacy and Associated Outcomes in Head and Neck Cancer Survivor-caregiver Dyads
Overview
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]
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Other
Study locations
United States · 1 center
- University of Kansas Medical Center — Kansas City
Identifiers
NCT: NCT07021885 · COE Pilot 2023