Head and Neck CancerNCT07021885
NLit and Outcomes in HNC Survivor-Caregiver Dyads
An observational study of Head and Neck Cancer and Caregiver Burden, run by University of Kansas Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Caregiver Burden, Health Knowledge, Attitudes, Practice
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2023to 16 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: post-treatment head and neck cancer survivors and a paired informal caregiver
Who may be able to join
- 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).
Who cannot join
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Anna Arthur, 913-945-7079, aarthur4@kumc.edu
About this study
Official title: Nutrition Literacy and Associated Outcomes in Head and Neck Cancer Survivor-caregiver Dyads
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:
Read more
- 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.
- Medical subject headings
- Head and Neck Neoplasms, Caregiver Burden, Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutrition Literacy
Measured by the self-administered Nutrition Literacy Assessment Instrument (NLit).
Measured: at a single time point between 6 months and 5 years post-treatment
Nutrition Status
Measured by the Mini Nutrition Assessment (MNA)
Measured: at a single time point between 6 months and 5 years post-treatment
Skin Carotenoid
Using the Veggie Meter®
Measured: at a single time point between 6 months and 5 years post-treatment
Body composition
Measured by BIA - InBody© 270, USA
Measured: at a single time point between 6 months and 5 years post-treatment
Functional status
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.
Measured: at a single time point between 6 months and 5 years post-treatment
Sociodemographics.
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.
Measured: at a single time point between 6 months and 5 years post-treatment
Fruit & Vegetable Intake
Using the Eating at America's Table Study's (EATS) All-Day screener designed, and validated by the National Cancer Institute
Measured: at a single time point between 6 months and 5 years post-treatment
Exercise
Assessed using a modified Godin Leisure-Time Exercise Questionnaire
Measured: at a single time point between 6 months and 5 years post-treatment
Food Security
Self-reported food security will be assessed using the USDA's U.S. Household Food Security Survey Module: Six-Item Short Form
Measured: At a single time point between 6 months and 5 years post-treatment
Caregiving characteristics
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
Measured: between 6 months and 5 years post-treatment
Quality of life
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.
Measured: between 6 months and 5 years post-treatment
Clinical characteristics
Tumor site, cancer stage, treatment modality, and HPV-status of the tumor will be collected through EMR review
Measured: between 6 months and 5 years post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start1 Dec 2023
- Primary completion16 Aug 2025 (estimated)
- Study completion16 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07021885
- Sponsor's protocol ID
- COE Pilot 2023
- Status last verified
- Jun 2025
- First submitted
- 29 May 2025
- Last updated
- 15 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition Literacy and Associated Outcomes in Head and Neck Cancer Survivor-caregiver Dyads
- ClinicalTrials.gov ID
- NCT07021885
- Acronym / sponsor ID
- COE Pilot 2023
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 16 Aug 2025 (estimated)
- Study completion
- 16 May 2026 (estimated)
- First posted
- 15 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- post-treatment head and neck cancer survivors and a paired informal caregiver
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (4 listed)
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Nutrition Literacy
Time frame: 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
Time frame: at a single time point between 6 months and 5 years post-treatment
Measured by the Mini Nutrition Assessment (MNA)
Skin Carotenoid
Time frame: at a single time point between 6 months and 5 years post-treatment
Using the Veggie Meter®
Body composition
Time frame: at a single time point between 6 months and 5 years post-treatment
Measured by BIA - InBody© 270, USA
Functional status
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: at a single time point between 6 months and 5 years post-treatment
Assessed using a modified Godin Leisure-Time Exercise Questionnaire
Food Security
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer and Caregiver Burden, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutrition Literacy (time frame: at a single time point between 6 months and 5 years post-treatment). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025; AzTrials last refreshed its copy on 8 Nov 2026.