Pediatric CancerMTM-KidsNCT06814795
Medically Tailored Meals for Kids
A study testing Medically tailored meals in people with Pediatric Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this project is to learn whether an intervention that provides households with home-delivered healthy, frozen meals tailored to illness related conditions for 12 weeks during a child's treatment for serious illness is feasible and acceptable to the child and parent mainly responsible for the child's… Read more about this study
- Who is it for?
- Ages 12 to 99 years
- Conditions the study is for
- Pediatric Cancer
- What is being tested?
- Medically tailored meals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2025to 21 Oct 2026
- Phase
- Interventional
- 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 12 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Eligible children (n=15) will:
- be under the care of The University of North Carolina at Chapel Hill School of Medicine, Department of Pediatrics, Division of Pediatric Hematology/Oncology
- have completed at least one cycle of cancer chemotherapy that included an agent known to cause alterations in taste,
- expect to undergo at least two more cycles,
- be aged 12-17.9 years
- communicate in English or Spanish.
Show all 10Show fewer
- Eligible adults (n=15) will:
- be the primary parental caregiver of a study-eligible child,
- be aged 18 years or older
- communicate in English or Spanish.
Who cannot join
- none if inclusion criteria are met
Trial locations and contacts
1 site in 1 country.
United States1 site
North Carolina Basnight Cancer Hospital
Chapel Hill, North Carolina, 27599
About this study
Official title: Feasibility of Medically Tailored Meals for Pediatric Populations at Risk for Disparities in Serious Illness Outcomes Due to Inequities in Social Drivers of Health (MTM-Kids)
The purpose of this project is to learn whether an intervention that provides households with home-delivered healthy, frozen meals tailored to illness related conditions for 12 weeks during a child's treatment for serious illness is feasible and acceptable to the child and parent mainly responsible for the child's care.
Read the detailed description
Food insecurity (uncertainty about having enough food for the household) and nutrition insecurity (uncertainty about access and affordability of foods that promotes health and quality of life [QOL]) are clinically-relevant, actionable social drivers of health (SDOH) disparities for pediatric (age 0-17.9 years) populations. Food and nutrition insecurity are especially relevant in pediatric populations vulnerable to disparities in outcomes of serious illnesses (life-threatening illnesses with taxing symptoms, treatments, and caregiving requirements). Pediatric cancer is an example. Children living in poverty with associated adverse SDOH are less likely survive either highly treatable cancers, or high-risk cancers that require regimens with costly targeted immunotherapy to optimize prospects for survival.. Poor nutrition increases risk of infection and poorer treatment tolerance, QOL, daily functioning and treatment responsiveness. Food-related insecurities may partly account for links between household poverty and poorer outcomes, and for the accelerated biological aging observed in pediatric and young adult cancer survivors. Moreover, poor eating habits developed treatment can persist into survivorship to heighten risks for secondary cardio-vascular conditions and cancers. Research on serious illness-related cost-coping suggests that parents and other primary caregivers legally and financially responsible for meeting the child's medical and day-to-day needs (hereafter "parents") may stretch food dollars by purchasing low priced, processed food with poor nutritional value. These purchasing choices contribute to household nutrition insecurity. Processed foods are also easy to prepare and thus appeal to parents who juggle time demands of complex caregiving and usual social roles. Because of chemotherapy-induced alterations in taste, these foods also appeal to young patients who crave food high in sugar and/or sodium. Parents and siblings may go without food and other essentials (needed health or dental care, prescribed medications [insulin], health insurance) to conserve the household's monetary assets to meet the needs of the child who is ill; these decisions heighten parent and sibling vulnerabilities to poorer health and QOL. In pediatric cancer, one approach being studied to address outcome disparities driven by food-related insecurities is to provide the household with gift cards for an online grocery delivery platform. Card amount is determined by household size and minimal cost for the Thrifty Food Plan per United States Department of Agriculture (USDA). No nutritional guidance is provided and parental time demands may limit their capacity to prepare healthy meals. To address health disparities in households experiencing food-related insecurities in the context of serious pediatric illness, holistic models that embed equity in care delivery by integrating food and nutrition interventions with state-of-the-science clinical care to address adverse SDOH are needed. Medically tailor meals (MTM) offer a Food is Medicine approach to addressing health disparities in pediatric serious illness populations. MTM comprise home-delivered meals tailored to medical needs of individuals with at risk for health disparities and barriers to preparing healthy food. In studies of adults, MTM interventions were associated with better health outcomes and less health care spending. Here, the investigators propose Medically-Tailored Meals for Kids (MTM-Kids), an extension of the MTM concept to pediatric serious illness populations for whom SDOH inequities affect outcomes, using pediatric cancer as the proof of concept. MTM-Kids account for nutritional needs, chemotherapy-induced alterations in taste, and illness-related financial burden and time demands. The purpose of the investigation is to determine feasibility of the MTM-methods and intervention for a future efficacy trial to improve food and nutrition security for children at risk for poorer outcomes due to SDOH inequities. The investigators will work with Equiti Foods, a small social enterprise that makes tasty, healthy, and culturally conscious frozen meals with start-up funding from National Institutes of Minority Health and Health Disparities. The primary research question is, "For households experiencing related insecurities, is providing healthy, frozen meals tailored to chemotherapy-induced alterations in taste feasible, appropriate and acceptable to children in active treatment for cancer and their parents?". After tailoring flavorings of the existing healthy, frozen means, the investigators will: 1. determine the feasibility, appropriateness, acceptability and accessibility of MTM-Kids; and 2. identify signals of change in food-related insecurities, cost coping, parental role demands and financial well-being. The investigation will be guided by the CONSORT extension for feasibility studies. Quantitative and qualitative feedback at multiple time points will enable rapid refinements of the MTM-Kids program and protocol for the future efficacy trial. The results will inform the potential for a future 2-group randomized efficacy trial with gift cards for an online grocery home delivery website as the likely comparator, and later cost effectiveness studies that advance our goal to extend healthcare financing models to include MTM in pediatric healthcare settings where seriously ill children receive care.
- Conditions
- Pediatric Cancer
- Being tested
- Medically tailored meals
- Keywords
- chemotherapy-induced alterations in taste, Food insecurity, Nutrition insecurity, Household material hardship, Resource hardship, Social drivers of health disparities
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medically tailored mealsOther
Also called MTM-Kids
The intervention will be 12-weeks in duration, with "doses" (meal deliveries) of up to 10 healthy, frozen meals per week for household use as needed, plus selected condiments for personalization
| Study group | Role | What they receive |
|---|---|---|
| Medically-tailored meals for children being treated for cancer with chemotherapy | Experimental | The intervention will be 12-weeks induration, with weekly "doses" (meal deliveries) of up to 10 healthy, frozen meals per week for household use as needed, plus selected condiments for personalization. Receives: Other: Medically tailored meals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent-reported feasibility, acceptability, appropriateness and accessibility of MTM-Kids
Each domain will be measured by 4-items developed by others and adapted for this study. Parents will be asked to read each item and indicate their response using 5-point scales anchored by 1=completely disagree and 5=completely aDomain scores will be calculated by summing item responses and dividing the sum by 4. Domain score range is 1-higher scores indicating better MTM program feasibility, acceptability, appropriateness and accessibility.
Measured: Baseline and 12 weeks
Adolescent-reported acceptability and appropriateness of MTM-Kids
Each of these two domains of feasibility will be measured using items developed and validated by others and adapted for this study. Each domain has 4-items. Adolescents will be asked to read each item and indicate their response using scales anchored by 1=completely disagree and 5=completely agree. Domain scores will be calculated by summing responses and dividing the sum by 4. Domain score range is 1-4, with higher scores indicating better acceptability appropriateness
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start25 Nov 2025
- Primary completion21 Oct 2026 (estimated)
- Study completion21 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility of study processes and the intervention
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Sheila J. Santacroce, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06814795
- Sponsor's protocol ID
- LCCC2427
- Other IDs
- R21NR021288
- Acronym
- MTM-Kids
- Status last verified
- Aug 2026
- First submitted
- 17 Jan 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon reasonable request
Publications
Coleman-Jensen A, Rabbitt MP, Gregory CA, Singh A. Household Food Security in the United States inU.S. Department of Agriculture Economic Research Service. Washington, D. C. 2022.
Mozaffarian D. Measuring and addressing nutritional secutiry to achieve health and health equity HeAffairs Health Policy Brief. March 30, 2023. https://doi.org/10.1377/hpb2023216.92558
COUNCIL ON COMMUNITY PEDIATRICS. Poverty and Child Health in the United States. Pediatrics. 2016 Apr;137(4):e20160339. doi: 10.1542/peds.2016-0339. Epub 2016 Mar 9.
PubMed 26962238Zenk SN, Tabak LA, Perez-Stable EJ. Research Opportunities to Address Nutrition Insecurity and Disparities. JAMA. 2022 May 24;327(20):1953-1954. doi: 10.1001/jama.2022.7159. No abstract available.
PubMed 35486390Kelley AS. Defining "serious illness". J Palliat Med. 2014 Sep;17(9):985. doi: 10.1089/jpm.2014.0164. Epub 2014 Aug 12. No abstract available.
PubMed 25115302Bona K, Blonquist TM, Neuberg DS, Silverman LB, Wolfe J. Impact of Socioeconomic Status on Timing of Relapse and Overall Survival for Children Treated on Dana-Farber Cancer Institute ALL Consortium Protocols (2000-2010). Pediatr Blood Cancer. 2016 Jun;63(6):1012-8. doi: 10.1002/pbc.25928. Epub 2016 Feb 23.
PubMed 26913850Wadhwa A, Chen Y, Hageman L, Hoppmann A, Angiolillo A, Dickens DS, Neglia JP, Ravindranath Y, Ritchey AK, Termuhlen A, Wong FL, Landier W, Bhatia S. Poverty and relapse risk in children with acute lymphoblastic leukemia: a Children's Oncology Group study AALL03N1 report. Blood. 2023 Jul 20;142(3):221-229. doi: 10.1182/blood.2023019631.
PubMed 37070673Bona K, Li Y, Winestone LE, Getz KD, Huang YS, Fisher BT, Desai AV, Richardson T, Hall M, Naranjo A, Henderson TO, Aplenc R, Bagatell R. Poverty and Targeted Immunotherapy: Survival in Children's Oncology Group Clinical Trials for High-Risk Neuroblastoma. J Natl Cancer Inst. 2021 Mar 1;113(3):282-291. doi: 10.1093/jnci/djaa107.
PubMed 33227816Barr RD, Gomez-Almaguer D, Jaime-Perez JC, Ruiz-Arguelles GJ. Importance of Nutrition in the Treatment of Leukemia in Children and Adolescents. Arch Med Res. 2016 Nov;47(8):585-592. doi: 10.1016/j.arcmed.2016.11.013.
PubMed 28476186Tripodi SI, Bergami E, Panigari A, Caissutti V, Brovia C, De Cicco M, Cereda E, Caccialanza R, Zecca M. The role of nutrition in children with cancer. Tumori. 2023 Feb;109(1):19-27. doi: 10.1177/03008916221084740. Epub 2022 Jun 19.
PubMed 35722985Berkowitz SA, Palakshappa D, Seligman HK, Hanmer J. Changes in Food Insecurity and Changes in Patient-Reported Outcomes: a Nationally Representative Cohort Study. J Gen Intern Med. 2022 Nov;37(14):3638-3644. doi: 10.1007/s11606-021-07293-4. Epub 2022 Jan 6.
PubMed 34993877Pedretti L, Massa S, Leardini D, Muratore E, Rahman S, Pession A, Esposito S, Masetti R. Role of Nutrition in Pediatric Patients with Cancer. Nutrients. 2023 Jan 30;15(3):710. doi: 10.3390/nu15030710.
PubMed 36771416Orgel E, Framson C, Buxton R, Kim J, Li G, Tucci J, Freyer DR, Sun W, Oberley MJ, Dieli-Conwright C, Mittelman SD. Caloric and nutrient restriction to augment chemotherapy efficacy for acute lymphoblastic leukemia: the IDEAL trial. Blood Adv. 2021 Apr 13;5(7):1853-1861. doi: 10.1182/bloodadvances.2020004018.
PubMed 33792627Bhatia S, Landier W, Hageman L, Kim H, Chen Y, Crews KR, Evans WE, Bostrom B, Casillas J, Dickens DS, Maloney KW, Neglia JP, Ravindranath Y, Ritchey AK, Wong FL, Relling MV. 6MP adherence in a multiracial cohort of children with acute lymphoblastic leukemia: a Children's Oncology Group study. Blood. 2014 Oct 9;124(15):2345-53. doi: 10.1182/blood-2014-01-552166. Epub 2014 May 14.
PubMed 24829202Gomez-Almaguer D, Ruiz-Arguelles GJ, Ponce-de-Leon S. Nutritional status and socio-economic conditions as prognostic factors in the outcome of therapy in childhood acute lymphoblastic leukemia. Int J Cancer Suppl. 1998;11:52-5. doi: 10.1002/(sici)1097-0215(1998)78:11+3.0.co;2-3.
PubMed 9876479
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Medically Tailored Meals for Pediatric Populations at Risk for Disparities in Serious Illness Outcomes Due to Inequities in Social Drivers of Health (MTM-Kids)
- ClinicalTrials.gov ID
- NCT06814795
- Acronym / sponsor ID
- MTM-Kids / LCCC2427
- Conditions
- Pediatric Cancer
- Keywords
- chemotherapy-induced alterations in taste, Food insecurity, Nutrition insecurity, Household material hardship, Resource hardship, Social drivers of health disparities
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- 21 Oct 2026 (estimated)
- Study completion
- 21 Oct 2026 (estimated)
- First posted
- 7 Feb 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 purpose of this project is to learn whether an intervention that provides households with home-delivered healthy, frozen meals tailored to illness related conditions for 12 weeks during a child's treatment for serious illness is feasible and acceptable to the child and parent mainly responsible for the child's care.
Detailed description
Food insecurity (uncertainty about having enough food for the household) and nutrition insecurity (uncertainty about access and affordability of foods that promotes health and quality of life [QOL]) are clinically-relevant, actionable social drivers of health (SDOH) disparities for pediatric (age 0-17.9 years) populations. Food and nutrition insecurity are especially relevant in pediatric populations vulnerable to disparities in outcomes of serious illnesses (life-threatening illnesses with taxing symptoms, treatments, and caregiving requirements). Pediatric cancer is an example. Children living in poverty with associated adverse SDOH are less likely survive either highly treatable cancers, or high-risk cancers that require regimens with costly targeted immunotherapy to optimize prospects for survival.. Poor nutrition increases risk of infection and poorer treatment tolerance, QOL, daily functioning and treatment responsiveness. Food-related insecurities may partly account for links between household poverty and poorer outcomes, and for the accelerated biological aging observed in pediatric and young adult cancer survivors. Moreover, poor eating habits developed treatment can persist into survivorship to heighten risks for secondary cardio-vascular conditions and cancers. Research on serious illness-related cost-coping suggests that parents and other primary caregivers legally and financially responsible for meeting the child's medical and day-to-day needs (hereafter "parents") may stretch food dollars by purchasing low priced, processed food with poor nutritional value. These purchasing choices contribute to household nutrition insecurity. Processed foods are also easy to prepare and thus appeal to parents who juggle time demands of complex caregiving and usual social roles. Because of chemotherapy-induced alterations in taste, these foods also appeal to young patients who crave food high in sugar and/or sodium. Parents and siblings may go without food and other essentials (needed health or dental care, prescribed medications [insulin], health insurance) to conserve the household's monetary assets to meet the needs of the child who is ill; these decisions heighten parent and sibling vulnerabilities to poorer health and QOL. In pediatric cancer, one approach being studied to address outcome disparities driven by food-related insecurities is to provide the household with gift cards for an online grocery delivery platform. Card amount is determined by household size and minimal cost for the Thrifty Food Plan per United States Department of Agriculture (USDA). No nutritional guidance is provided and parental time demands may limit their capacity to prepare healthy meals. To address health disparities in households experiencing food-related insecurities in the context of serious pediatric illness, holistic models that embed equity in care delivery by integrating food and nutrition interventions with state-of-the-science clinical care to address adverse SDOH are needed. Medically tailor meals (MTM) offer a Food is Medicine approach to addressing health disparities in pediatric serious illness populations. MTM comprise home-delivered meals tailored to medical needs of individuals with at risk for health disparities and barriers to preparing healthy food. In studies of adults, MTM interventions were associated with better health outcomes and less health care spending. Here, the investigators propose Medically-Tailored Meals for Kids (MTM-Kids), an extension of the MTM concept to pediatric serious illness populations for whom SDOH inequities affect outcomes, using pediatric cancer as the proof of concept. MTM-Kids account for nutritional needs, chemotherapy-induced alterations in taste, and illness-related financial burden and time demands. The purpose of the investigation is to determine feasibility of the MTM-methods and intervention for a future efficacy trial to improve food and nutrition security for children at risk for poorer outcomes due to SDOH inequities. The investigators will work with Equiti Foods, a small social enterprise that makes tasty, healthy, and culturally conscious frozen meals with start-up funding from National Institutes of Minority Health and Health Disparities. The primary research question is, "For households experiencing related insecurities, is providing healthy, frozen meals tailored to chemotherapy-induced alterations in taste feasible, appropriate and acceptable to children in active treatment for cancer and their parents?". After tailoring flavorings of the existing healthy, frozen means, the investigators will: 1. determine the feasibility, appropriateness, acceptability and accessibility of MTM-Kids; and 2. identify signals of change in food-related insecurities, cost coping, parental role demands and financial well-being. The investigation will be guided by the CONSORT extension for feasibility studies. Quantitative and qualitative feedback at multiple time points will enable rapid refinements of the MTM-Kids program and protocol for the future efficacy trial. The results will inform the potential for a future 2-group randomized efficacy trial with gift cards for an online grocery home delivery website as the likely comparator, and later cost effectiveness studies that advance our goal to extend healthcare financing models to include MTM in pediatric healthcare settings where seriously ill children receive care.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility of study processes and the intervention
| Arm | Type | Receives |
|---|---|---|
| Medically-tailored meals for children being treated for cancer with chemotherapy | Experimental | Other: Medically tailored mealsThe intervention will be 12-weeks induration, with weekly "doses" (meal deliveries) of up to 10 healthy, frozen meals per week for household use as needed, plus selected condiments for personalization. |
Who may qualify
- Ages
- 12 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- be under the care of The University of North Carolina at Chapel Hill School of Medicine, Department of Pediatrics, Division of Pediatric Hematology/Oncology
- have completed at least one cycle of cancer chemotherapy that included an agent known to cause alterations in taste,
- expect to undergo at least two more cycles,
- be aged 12-17.9 years
- communicate in English or Spanish.
Key exclusion criteria (1 listed)
- none if inclusion criteria are met
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medically tailored mealsAlso: MTM-KidsThe intervention will be 12-weeks in duration, with "doses" (meal deliveries) of up to 10 healthy, frozen meals per week for household use as needed, plus selected condiments for personalization | Other | Medically-tailored meals for children being treated for cancer with chemotherapy |
Primary outcome
Parent-reported feasibility, acceptability, appropriateness and accessibility of MTM-Kids
Time frame: Baseline and 12 weeks
Each domain will be measured by 4-items developed by others and adapted for this study. Parents will be asked to read each item and indicate their response using 5-point scales anchored by 1=completely disagree and 5=completely aDomain scores will be calculated by summing item responses and dividing the sum by 4. Domain score range is 1-higher scores indicating better MTM program feasibility, acceptability, appropriateness and accessibility.
Adolescent-reported acceptability and appropriateness of MTM-Kids
Time frame: Baseline and 12 weeks
Each of these two domains of feasibility will be measured using items developed and validated by others and adapted for this study. Each domain has 4-items. Adolescents will be asked to read each item and indicate their response using scales anchored by 1=completely disagree and 5=completely agree. Domain scores will be calculated by summing responses and dividing the sum by 4. Domain score range is 1-4, with higher scores indicating better acceptability appropriateness
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 27 Aug 2026.
- BackgroundColeman-Jensen A, Rabbitt MP, Gregory CA, Singh A. Household Food Security in the United States inU.S. Department of Agriculture Economic Research Service. Washington, D. C. 2022.
- BackgroundMozaffarian D. Measuring and addressing nutritional secutiry to achieve health and health equity HeAffairs Health Policy Brief. March 30, 2023. https://doi.org/10.1377/hpb2023216.92558
- Background: PubMed 26962238COUNCIL ON COMMUNITY PEDIATRICS. Poverty and Child Health in the United States. Pediatrics. 2016 Apr;137(4):e20160339. doi: 10.1542/peds.2016-0339. Epub 2016 Mar 9.
- Background: PubMed 35486390Zenk SN, Tabak LA, Perez-Stable EJ. Research Opportunities to Address Nutrition Insecurity and Disparities. JAMA. 2022 May 24;327(20):1953-1954. doi: 10.1001/jama.2022.7159. No abstract available.
- Background: PubMed 25115302Kelley AS. Defining "serious illness". J Palliat Med. 2014 Sep;17(9):985. doi: 10.1089/jpm.2014.0164. Epub 2014 Aug 12. No abstract available.
- Background: PubMed 26913850Bona K, Blonquist TM, Neuberg DS, Silverman LB, Wolfe J. Impact of Socioeconomic Status on Timing of Relapse and Overall Survival for Children Treated on Dana-Farber Cancer Institute ALL Consortium Protocols (2000-2010). Pediatr Blood Cancer. 2016 Jun;63(6):1012-8. doi: 10.1002/pbc.25928. Epub 2016 Feb 23.
- Background: PubMed 37070673Wadhwa A, Chen Y, Hageman L, Hoppmann A, Angiolillo A, Dickens DS, Neglia JP, Ravindranath Y, Ritchey AK, Termuhlen A, Wong FL, Landier W, Bhatia S. Poverty and relapse risk in children with acute lymphoblastic leukemia: a Children's Oncology Group study AALL03N1 report. Blood. 2023 Jul 20;142(3):221-229. doi: 10.1182/blood.2023019631.
- Background: PubMed 33227816Bona K, Li Y, Winestone LE, Getz KD, Huang YS, Fisher BT, Desai AV, Richardson T, Hall M, Naranjo A, Henderson TO, Aplenc R, Bagatell R. Poverty and Targeted Immunotherapy: Survival in Children's Oncology Group Clinical Trials for High-Risk Neuroblastoma. J Natl Cancer Inst. 2021 Mar 1;113(3):282-291. doi: 10.1093/jnci/djaa107.
- Background: PubMed 28476186Barr RD, Gomez-Almaguer D, Jaime-Perez JC, Ruiz-Arguelles GJ. Importance of Nutrition in the Treatment of Leukemia in Children and Adolescents. Arch Med Res. 2016 Nov;47(8):585-592. doi: 10.1016/j.arcmed.2016.11.013.
- Background: PubMed 35722985Tripodi SI, Bergami E, Panigari A, Caissutti V, Brovia C, De Cicco M, Cereda E, Caccialanza R, Zecca M. The role of nutrition in children with cancer. Tumori. 2023 Feb;109(1):19-27. doi: 10.1177/03008916221084740. Epub 2022 Jun 19.
- Background: PubMed 34993877Berkowitz SA, Palakshappa D, Seligman HK, Hanmer J. Changes in Food Insecurity and Changes in Patient-Reported Outcomes: a Nationally Representative Cohort Study. J Gen Intern Med. 2022 Nov;37(14):3638-3644. doi: 10.1007/s11606-021-07293-4. Epub 2022 Jan 6.
- Background: PubMed 36771416Pedretti L, Massa S, Leardini D, Muratore E, Rahman S, Pession A, Esposito S, Masetti R. Role of Nutrition in Pediatric Patients with Cancer. Nutrients. 2023 Jan 30;15(3):710. doi: 10.3390/nu15030710.
- Individual participant dataSharing planned: Yes. Upon reasonable request
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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. This study is not recruiting at the moment.
Sheila J. Santacroce principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medically tailored meals in people with Pediatric Cancer, run by UNC Lineberger Comprehensive Cancer 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 10 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 27 Aug 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent-reported feasibility, acceptability, appropriateness and accessibility of MTM-Kids (time frame: Baseline and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06814795, which also lists 35 linked publications.
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 27 Aug 2026.