Nutrition OUtReach In Systems of Healthcare

Overview

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.

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.

Interventions

• Other Food Bags
  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.

Primary outcome measures

• Peri-Transplant and Cell Therapy Malnutrition [Time frame: Through Day 100]

Secondary outcome measures (12)

• Peri-TCT Incidence of Infections [Time frame: Through Day 100]
• Peri-TCT Incidence of Acute Graft-vs-Host-Disease [Time frame: Through Day 180]
• Peri-TCT Incidence of Chronic Graft-vs-Host Disease [Time frame: Through Year 1]
• Incidence of Relapse [Time frame: Through Year 1]
• Incidence of Treatment-Related Mortality [Time frame: Through End of Study]
• Overall Survival [Time frame: Through Year 1]
• Quality of Life (PROMIS-29 Score) [Time frame: At Day 100 and at Year 1]
• Financial Toxicity [Time frame: Day 100 and Year 1]
• Physical Function [Time frame: At Day 100 and at Year 1]
• Cognitive Function [Time frame: At Day 100 and at Year 1]
• Mental Health [Time frame: At Day 100 and at Year 1]
• Dietary Habits and Consumption [Time frame: At Year 1]

Eligibility criteria

Inclusion criteria

• 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)

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 4 centers

• Stanford University — Stanford
• University of Kansas Cancer Center — Fairway
• Memorial Sloan Kettering Cancer Center — New York
• Duke University — Durham

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. PMID 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 202 PMID 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. PMID 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 PMID 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. PMID 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. PMID 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. PMID 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. PMID 32152215

Identifiers

NCT: NCT06802406 · NOURISH · R01NR021468

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗