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ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATIONNOURISHNCT06802406

Nutrition OUtReach In Systems of Healthcare

A study testing Food Bags in people with ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION and Autologous Haemopoietic Stem Cell Transplant, run by University of Kansas Medical Center at 4 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Many children and adults receiving medical treatments have higher costs, which can make it harder for them to afford groceries. When someone can't afford enough food, and they do not receive proper nutrition it can make treatment more difficult. Read more about this study

Who is it for?
Ages 8 to 80 years
What is being tested?
Food Bags
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
4 sitesUnited States
Study dates
1 May 2025to May 2029
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 8 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Planning to receive transplant or cell therapy
  • Screen positive for food insecurity by answering "often true" or "sometimes true" to one of the following:
  • "Within the past 12 months, you worried that your food would run out before you got money to buy more,"
  • "Within the past 12 months, the food you bought just didn't last and you didn't have money to get more."
  • Age 8 - 80
  • Able to read/write English or Spanish (many patient-reported outcome measures lack validated translations in other languages)

Who cannot join

  • Patients who do not tolerate oral nutrition at the time of study enrollment

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Anthony Sung, MD contact

913-588-1227

asung2@kumc.edu

United States4 sites, 4 recruiting

  • Duke University

    Durham, North Carolina, 27705

    Kris Mahadeo, MD, 919-668-1100, kris.mahadeo@duke.edu

    Kris Mahadeo, MD

    Not yet recruiting

  • University of Kansas Cancer Center

    Fairway, Kansas, 66205

    Anthony Sung, MD, 913-588-1227, asung2@kumc.edu

    Anthony Sung, MD

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Jonathan Peled, MD, 646-888-2105, peledj@mskcc.org

    Jonathan Peled, MD

    Not yet recruiting

  • Stanford University

    Stanford, California, 94305

    Andrew Rezvani, MD, 650-723-0822, arezvani@stanford.edu

    Andrew Rezvani, MD

    Not yet recruiting

Other trials in United States

About this study

Many children and adults receiving medical treatments have higher costs, which can make it harder for them to afford groceries. When someone can't afford enough food, and they do not receive proper nutrition it can make treatment more difficult.

By doing this study investigators hope to learn more about whether addressing food insecurity by giving patients bags of food in clinic can help improve nutrition, reduce costs, and improve transplant and cellular therapy outcomes.

Read the detailed description

Food insecurity (FI), defined as a lack of consistent access to enough food for every person in a household to live an active, healthy life due to insufficient money or other resources, affects 17 million (12.8%) of American households. FI is exacerbated in patients with complex medical conditions, and it is associated with worse health outcomes and increased healthcare utilization and costs. Strategies to address FI such as home-delivered meals or food assistance programs like the Supplemental Nutrition Assistance Program (SNAP) and food banks/pantries/pharmacies may improve healthcare outcomes. However, home-delivered meals are associated with higher costs due to individualized delivery while food assistance programs have several barriers to participation. We propose to leverage the strengths of both those approaches in a novel healthcare-community partnership between cancer centers and food banks called Nutrition OUtReach In Systems of Healthcare (NOURISH), to directly deliver food to patients in clinic. Patients, caregivers, dietitians, social workers, nurses, physicians, food bank staff, and community members will work together to determine medically tailored options for the patient population; food banks will oversee sourcing and preparing bags of food; and healthcare providers will distribute bags to patients in clinic after their appointments. Because NOURISH does not require patients to make an extra trip and bags are distributed discreetly to avoid stigma, it increases adoption; because food is handed out in clinic, it lowers costs. We propose to evaluate NOURISH in a multicenter randomized controlled trial in FI patients with hematologic malignancies receiving transplant and cellular therapy (TCT). We chose this population for three reasons: (1) TCT patients are in great need as approximately 75% will relocate to live near a quaternary cancer center (QCC) for a month or more while receiving TCT, removing them from their normal sources of support; (2) TCT patients are at high risk for malnutrition and other adverse outcomes, often struggling with nausea, anorexia, and other side effects that can be exacerbated by FI; (3) TCT may be a model for sustaining care: while other Food is Medicine initiatives have shown economic benefits, because cost savings do not flow to healthcare systems, there is little incentive for implementation. In contrast, TCT is among the most expensive medical procedures, and healthcare systems are typically reimbursed through bundled payments. As a result, QCCs have an incentive to pursue strategies that may lower costs and improve outcomes. For example, many TCT patients with FI will receive total parenteral nutrition, at significant cost. NOURISH may prevent malnutrition and the need for intravenous nutrition through much cheaper food assistance. The success of our randomized controlled trial will provide a compelling rationale for QCCs to continue to fund food banks in their communities, providing much-needed financial support to sustain these partnerships while improving access and outcomes for patients. Furthermore, positive experiences in TCT may lead to the expansion of these healthcare-community partnerships to the broader cancer population and beyond.

Being tested
Food Bags
Keywords
nutrition, food insecurity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Food BagsOther

    Also called NOURISH

    Participants will receive bags of shelf-stable food for 2-3 days for one individual twice a week in clinic. They will also receive recipes, handouts, and videos to help with education and food preparation.

Study groups in NCT06802406
Study groupRoleWhat they receive
Information GroupNo interventionThese participants will receive information on their local food banks according to standard of care.
Food Bags GroupExperimentalPatients will be given bags of shelf-stable food for 2-3 days for one individual twice a week in clinic. Additionally, they will receive recipes, handouts, and videos to help with education and food preparation.
Receives: Other: Food Bags

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Peri-Transplant and Cell Therapy Malnutrition

    Assessed by Global Leader Initiative on Malnutrition and confirmed by a dietitian

    Measured: Through Day 100

Secondary outcomes (19)

  1. Peri-TCT Incidence of Infections

    Incidence and subtypes (blood stream, respiratory, or other) of infections captured as standard of care.

    Measured: Through Day 100

  2. Peri-TCT Incidence of Acute Graft-vs-Host-Disease

    Incidence of acute GVHD captured as standard of care.

    Measured: Through Day 180

  3. Peri-TCT Incidence of Chronic Graft-vs-Host Disease

    Incidence of chronic GVHD captured as standard of care.

    Measured: Through Year 1

  4. Incidence of Relapse

    Incidence of relapse captured as standard of care.

    Measured: Through Year 1

  5. Incidence of Treatment-Related Mortality

    Incidence of treatment-related mortality captured as standard of care.

    Measured: Through End of Study

  6. Overall Survival

    Overall survival captured as standard of care.

    Measured: Through Year 1

  7. Quality of Life (PROMIS-29 Score)

    Quality of life as measured by Patient-Reported Outcome Measurement Information System-29 (PROMIS-29) score. The PROMIS-29 uses a scale of 1 to 5, with higher numbers representing a higher frequency, intensity, or duration.

    Measured: At Day 100 and at Year 1

  8. Financial Toxicity

    Financial toxicity measured by average Functional Assessment in Chronic Illness Therapy-COST: A FACIT Measure of Financial Toxicity (FACIT-COST) score. The FACIT-COST result scale ranges from a minimum of 0 to a maximum of 44, with a higher number representing better financial well-being.

    Measured: Day 100 and Year 1

  9. Physical Function

    Physical function measured by average 6 minute walk test distance.

    Measured: At Day 100 and at Year 1

  10. Cognitive Function

    Cognitive function measured by average MOntreal Cognitive Assessment (MOCA) score. The MOCA score ranges from a minimum of 0 to a maximum of 30, with a higher score indicating better cognitive function.

    Measured: At Day 100 and at Year 1

  11. Mental Health

    Mental health as measured by percentage of patients who are positive on the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 uses a scale ranging from a minimum of 0 to a maximum of 27, interpreted as 1-13: mild depression; 14-19: moderate depression; and 20-27: severe depression.

    Measured: At Day 100 and at Year 1

  12. Dietary Habits and Consumption

    Dietary habits and consumption measured by overall diet quality scores assessed using the Healthy Eating Index (HEI)-2020. The HEI-2020 uses a scale ranging from a minimum of 0 to a maximum of 100, with a higher number indicating a diet more closely aligned with recommended dietary guidelines.

    Measured: At Year 1

  13. Dietary Habits and Consumption

    Dietary habits and consumption measured by overall diet quality scores assessed using the National Cancer Institute (NCI) Multi-Factor Screener. The NCI Multifactor Screener provides an estimate of intake of percent energy from fat consumed per day.

    Measured: At Year 1

  14. Dietary Habits and Consumption

    Dietary habits and consumption measured by overall diet quality scores assessed using the National Cancer Institute (NCI) Multi-Factor Screener. The NCI Multifactor Screener provides an intake estimate of fiber (grams) consumed per day.

    Measured: At Year 1

  15. Dietary Habits and Consumption

    Dietary habits and consumption measured by overall diet quality scores assessed using the National Cancer Institute (NCI) Multi-Factor Screener. The NCI Multifactor Screener provides an estimate of fruit and vegetable intake (servings) consumed per day.

    Measured: At Year 1

  16. Dietary Habits and Consumption

    Dietary habits and consumption measured by overall diet quality scores assessed using the World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) Cancer Prevention Score. The WCRF/AICR Cancer Prevention Score ranges from a minimum of 0 to a maximum of 10, with a higher number representing greater adherence to cancer prevention recommendations.

    Measured: At Year 1

  17. Impact on Food Insecurity

    Measured by the United States Department of Agriculture Adult Food Security Module (USDA AFSM) Short Form survey. The USDA AFSM Short Form Survey uses a raw scoring scale from a minimum of 0 to a maximum of 6, with a higher number indicating greater food insecurity.

    Measured: At Year 1

  18. Social Determinants of Health

    Social determinants of health measured by the Centers for Medicare \& Medicaid Services Accountable Health Communities Health Related Social Needs (CMS AHC HRSN)10-item survey tool.

    Measured: At workup and at Year 1

  19. Fried Frailty

    Fried Frailty measured by percentage of patients meeting 3 or more of the diagnostic criteria for frailty.

    Measured: At Day 100 and at Year 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2025
  2. Study start1 May 2025
  3. Primary completionAug 2028 (estimated)
  4. Study completionMay 2029 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06802406
Sponsor's protocol ID
NOURISH
Other IDs
R01NR021468
Acronym
NOURISH
Status last verified
Apr 2026
First submitted
11 Dec 2024
Last updated
20 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Davis DH, Creavin ST, Yip JL, Noel-Storr AH, Brayne C, Cullum S. Montreal Cognitive Assessment for the detection of dementia. Cochrane Database Syst Rev. 2021 Jul 13;7(7):CD010775. doi: 10.1002/14651858.CD010775.pub3.

    PubMed 34255351

  • Schluter J, Peled JU, Taylor BP, Markey KA, Smith M, Taur Y, Niehus R, Staffas A, Dai A, Fontana E, Amoretti LA, Wright RJ, Morjaria S, Fenelus M, Pessin MS, Chao NJ, Lew M, Bohannon L, Bush A, Sung AD, Hohl TM, Perales MA, van den Brink MRM, Xavier JB. The gut microbiota is associated with immune cell dynamics in humans. Nature. 2020 Dec;588(7837):303-307. doi: 10.1038/s41586-020-2971-8. Epub 2020 Nov 25.

    PubMed 33239790

  • Clarke SF, Murphy EF, O'Sullivan O, Lucey AJ, Humphreys M, Hogan A, Hayes P, O'Reilly M, Jeffery IB, Wood-Martin R, Kerins DM, Quigley E, Ross RP, O'Toole PW, Molloy MG, Falvey E, Shanahan F, Cotter PD. Exercise and associated dietary extremes impact on gut microbial diversity. Gut. 2014 Dec;63(12):1913-20. doi: 10.1136/gutjnl-2013-306541. Epub 2014 Jun 9.

    PubMed 25021423

  • Hussaini SMQ, Ren Y, Racioppi A, Lew MV, Bohannon L, Johnson E, Li Y, Thompson JC, Henshall B, Darby M, Choi T, Lopez RD, Sarantopoulos S, Gasparetto C, Long GD, Horwitz ME, Chao NJ, Zafar SY, Sung AD. Financial Toxicity and Quality of Life in Patients Undergoing Stem-Cell Transplant Evaluation: A Single-Center Analysis. JCO Oncol Pract. 2024 Mar;20(3):351-360. doi: 10.1200/OP.23.00243. Epub 2023 Dec 21.

    PubMed 38127876

  • Faul F, Erdfelder E, Buchner A, Lang AG. Statistical power analyses using G*Power 3.1: tests for correlation and regression analyses. Behav Res Methods. 2009 Nov;41(4):1149-60. doi: 10.3758/BRM.41.4.1149.

    PubMed 19897823

  • David LA, Maurice CF, Carmody RN, Gootenberg DB, Button JE, Wolfe BE, Ling AV, Devlin AS, Varma Y, Fischbach MA, Biddinger SB, Dutton RJ, Turnbaugh PJ. Diet rapidly and reproducibly alters the human gut microbiome. Nature. 2014 Jan 23;505(7484):559-63. doi: 10.1038/nature12820. Epub 2013 Dec 11.

    PubMed 24336217

  • Clinton SK, Giovannucci EL, Hursting SD. The World Cancer Research Fund/American Institute for Cancer Research Third Expert Report on Diet, Nutrition, Physical Activity, and Cancer: Impact and Future Directions. J Nutr. 2020 Apr 1;150(4):663-671. doi: 10.1093/jn/nxz268.

    PubMed 31758189

  • Shams-White MM, Romaguera D, Mitrou P, Reedy J, Bender A, Brockton NT. Further Guidance in Implementing the Standardized 2018 World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) Score. Cancer Epidemiol Biomarkers Prev. 2020 May;29(5):889-894. doi: 10.1158/1055-9965.EPI-19-1444. Epub 2020 Mar 9.

    PubMed 32152215

  • Shams-White MM, Brockton NT, Mitrou P, Romaguera D, Brown S, Bender A, Kahle LL, Reedy J. Operationalizing the 2018 World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) Cancer Prevention Recommendations: A Standardized Scoring System. Nutrients. 2019 Jul 12;11(7):1572. doi: 10.3390/nu11071572.

    PubMed 31336836

  • David LA, Weil A, Ryan ET, Calderwood SB, Harris JB, Chowdhury F, Begum Y, Qadri F, LaRocque RC, Turnbaugh PJ. Gut microbial succession follows acute secretory diarrhea in humans. mBio. 2015 May 19;6(3):e00381-15. doi: 10.1128/mBio.00381-15.

    PubMed 25991682

  • Siamakpour-Reihani S, Cao F, Lyu J, Ren Y, Nixon AB, Xie J, Bush AT, Starr MD, Bain JR, Muehlbauer MJ, Ilkayeva O, Byers Kraus V, Huebner JL, Chao NJ, Sung AD. Evaluating immune response and metabolic related biomarkers pre-allogenic hematopoietic stem cell transplant in acute myeloid leukemia. PLoS One. 2022 Jun 14;17(6):e0268963. doi: 10.1371/journal.pone.0268963. eCollection 2022.

    PubMed 35700185

  • Parker D, Sloane R, Pieper CF, Hall KS, Kraus VB, Kraus WE, Huebner JL, Ilkayeva OR, Bain JR, Newby LK, Cohen HJ, Morey MC. Age-Related Adverse Inflammatory and Metabolic Changes Begin Early in Adulthood. J Gerontol A Biol Sci Med Sci. 2019 Feb 15;74(3):283-289. doi: 10.1093/gerona/gly121.

    PubMed 29985987

  • Maecker HT, McCoy JP, Nussenblatt R. Standardizing immunophenotyping for the Human Immunology Project. Nat Rev Immunol. 2012 Feb 17;12(3):191-200. doi: 10.1038/nri3158.

    PubMed 22343568

  • Alsaggaf R, Katta S, Wang T, Hicks BD, Zhu B, Spellman SR, Lee SJ, Horvath S, Gadalla SM. Epigenetic Aging and Hematopoietic Cell Transplantation in Patients With Severe Aplastic Anemia. Transplant Cell Ther. 2021 Apr;27(4):313.e1-313.e8. doi: 10.1016/j.jtct.2021.01.013. Epub 2021 Jan 16.

    PubMed 33836872

  • Ulrich S, Hildenbrand FF, Treder U, Fischler M, Keusch S, Speich R, Fasnacht M. Reference values for the 6-minute walk test in healthy children and adolescents in Switzerland. BMC Pulm Med. 2013 Aug 5;13:49. doi: 10.1186/1471-2466-13-49.

    PubMed 23915140

Questions about this trial

What is this clinical trial studying?

A study testing Food Bags in people with ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION and Autologous Haemopoietic Stem Cell Transplant, run by University of Kansas Medical Center at 4 sites 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 6 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: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

Contact Anthony Sung, MD (913-588-1227, asung2@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peri-Transplant and Cell Therapy Malnutrition (time frame: Through Day 100). 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 NCT06802406, which also lists 88 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 20 Apr 2026.

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