[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07021885":3,"trial-entities:NCT07021885":102,"trial-summary:NCT07021885":106},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":21,"study_type":22,"primary_purpose":15,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":28,"secondary_outcomes":68,"sex":69,"minimum_age":70,"maximum_age":15,"healthy_volunteers":15,"eligibility_criteria":71,"std_ages":80,"locations":83,"central_contacts":98,"overall_officials":99,"references":100,"see_also_links":101},"NCT07021885","COE Pilot 2023","NLit and Outcomes in HNC Survivor-Caregiver Dyads","Nutrition Literacy and Associated Outcomes in Head and Neck Cancer Survivor-caregiver Dyads","RECRUITING","2026-05-16","2025-06","2025-06-15","2023-12-01","University of Kansas Medical Center","OTHER",null,"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.\n\nThe main questions we aim to answer are:\n\n* How does the nutrition literacy of both the survivor and caregiver relate to their sociodemographic, behavioral, and clinical characteristics?\n* How dyadic nutrition literacy influence individual nutrition outcomes like skin carotenoid levels, body composition, and functional status?\n* Does the shared nutrition knowledge (nutrition literacy) of both the survivor and caregiver impact their quality of life together?\n\nParticipants will:\n\nAnswer 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.\n\nHave a simple and painless test to measure their body composition - like how much muscle and fat they have.\n\nDo some physical tests like grip strength and walking to measure their physical ability.\n\nAnswer questions about their general well-being and lifestyle, like exercise and diet.\n\n(For the survivor) Share details about their cancer, its treatment, and their overall well-being.\n\n(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.",[18,19,20],"Head and Neck Cancer","Caregiver Burden","Health Knowledge, Attitudes, Practice",[],"OBSERVATIONAL",[],{"count":25,"type":26},150,"ESTIMATED",[],[29,33,36,39,42,45,48,51,54,58,62,65],{"measure":30,"description":31,"timeFrame":32},"Nutrition Literacy","Measured by the self-administered Nutrition Literacy Assessment Instrument (NLit).","at a single time point between 6 months and 5 years post-treatment",{"measure":34,"description":35,"timeFrame":32},"Nutrition Status","Measured by the Mini Nutrition Assessment (MNA)",{"measure":37,"description":38,"timeFrame":32},"Skin Carotenoid","Using the Veggie Meter®",{"measure":40,"description":41,"timeFrame":32},"Body composition","Measured by BIA - InBody© 270, USA",{"measure":43,"description":44,"timeFrame":32},"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.",{"measure":46,"description":47,"timeFrame":32},"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.",{"measure":49,"description":50,"timeFrame":32},"Fruit & Vegetable Intake","Using the Eating at America's Table Study's (EATS) All-Day screener designed, and validated by the National Cancer Institute",{"measure":52,"description":53,"timeFrame":32},"Exercise","Assessed using a modified Godin Leisure-Time Exercise Questionnaire",{"measure":55,"description":56,"timeFrame":57},"Food Security","Self-reported food security will be assessed using the USDA's U.S. Household Food Security Survey Module: Six-Item Short Form","At a single time point between 6 months and 5 years post-treatment",{"measure":59,"description":60,"timeFrame":61},"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","between 6 months and 5 years post-treatment",{"measure":63,"description":64,"timeFrame":61},"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.",{"measure":66,"description":67,"timeFrame":61},"Clinical characteristics","Tumor site, cancer stage, treatment modality, and HPV-status of the tumor will be collected through EMR review",[],"ALL","18 Years",{"inclusion":72,"exclusion":74,"raw_text":79},[73],"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\u002For 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).",[75,76,77,78],"Adults unable to consent","Individuals who are not yet adults (infants, children, teenagers)","Pregnant women","Prisoners","Inclusion Criteria:\n\n* 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\u002For 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).\n\nExclusion Criteria:\n\n* Adults unable to consent\n* Individuals who are not yet adults (infants, children, teenagers)\n* Pregnant women\n* Prisoners",[81,82],"ADULT","OLDER_ADULT",[84],{"facility":13,"status":8,"city":85,"state":86,"zip":87,"country":88,"contacts":89,"geoPoint":95},"Kansas City","Kansas","66160","United States",[90],{"name":91,"role":92,"phone":93,"email":94},"Anna Arthur","CONTACT","913-945-7079","aarthur4@kumc.edu",{"lat":96,"lon":97},39.11417,-94.62746,[],[],[],[],{"nct_id":4,"conditions":103,"biomarkers":105},[104],"Malignant Head and Neck Neoplasm",[],{"nct_id":4,"found":107,"summary":108,"prompt_version":118},true,{"design":109,"status":110,"heading":111,"summary":112,"follow_up":113,"word_count":114,"commitments":115,"compensation":116,"drugs_mentioned":117},"This is an observational study planning to include 150 participants. It is designed to look at information at a single point in time.","completed","Understanding Nutrition in Head and Neck Cancer Survivors and Caregivers","This study aims to understand how well head and neck cancer survivors and their caregivers understand nutrition, and how this knowledge affects their health and quality of life. We are looking for survivors who are 6 months to 4 years past their main cancer treatment and have no signs of cancer, along with an informal caregiver who helps with food. We will measure nutrition literacy (how well you understand nutrition information), nutrition status, and skin carotenoid levels (a measure of antioxidant intake) at one point in time. This study will help us learn more about the connection between nutrition knowledge and overall well-being for both survivors and their caregivers.","Measurements will be taken at a single time point between 6 months and 5 years post-treatment.",109,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]