Clinical trial NCT06802406: Nutrition OUtReach In Systems of Healthcare
Official title: Nutrition OUtReach In Systems of Healthcare
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION
Autologous Haemopoietic Stem Cell Transplant
CAR-T Cell Therapy
Food Insecurity
Keywords: nutrition, food insecurity
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Duke University
name: Stanford University
name: Memorial Sloan-Kettering Cancer Center, USA
name: National Institute of Nursing Research (NINR)
First posted: 2025-01-31
Enrollment: 210
Sex: ALL
Minimum age (years): 8
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

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

Primary outcomes:
measure: Peri-Transplant and Cell Therapy Malnutrition
timeFrame: Through Day 100
Secondary outcomes:
measure: Peri-TCT Incidence of Infections
timeFrame: Through Day 100
measure: Peri-TCT Incidence of Acute Graft-vs-Host-Disease
timeFrame: Through Day 180
measure: Peri-TCT Incidence of Chronic Graft-vs-Host Disease
timeFrame: Through Year 1
measure: Incidence of Relapse
timeFrame: Through Year 1
measure: Incidence of Treatment-Related Mortality
timeFrame: Through End of Study
measure: Overall Survival
timeFrame: Through Year 1
measure: Quality of Life (PROMIS-29 Score)
timeFrame: At Day 100 and at Year 1
measure: Financial Toxicity
timeFrame: Day 100 and Year 1
measure: Physical Function
timeFrame: At Day 100 and at Year 1
measure: Cognitive Function
timeFrame: At Day 100 and at Year 1
measure: Mental Health
timeFrame: At Day 100 and at Year 1
measure: Dietary Habits and Consumption
timeFrame: At Year 1
measure: Dietary Habits and Consumption
timeFrame: At Year 1
measure: Dietary Habits and Consumption
timeFrame: At Year 1
measure: Dietary Habits and Consumption
timeFrame: At Year 1
measure: Dietary Habits and Consumption
timeFrame: At Year 1
measure: Impact on Food Insecurity
timeFrame: At Year 1
measure: Social Determinants of Health
timeFrame: At workup and at Year 1
measure: Fried Frailty
timeFrame: At Day 100 and at Year 1
Other outcomes:
measure: Muscle Health
timeFrame: At Day 100 and at Year 1
measure: Muscle Health
timeFrame: At Day 100 and at Year 1
measure: Muscle Health
timeFrame: At Day 100 and at Year 1
measure: Muscle Health
timeFrame: At Day 100 and at Year 1
measure: Accelerated Aging
timeFrame: At Year 1
measure: Home Food Bank Utilization
timeFrame: At Year 1
measure: Impact of NOURISH on Reducing Healthcare Costs
timeFrame: At Year 1
measure: Impact of NOURISH on Reducing Healthcare Costs
timeFrame: At Year 1
measure: Impact of NOURISH on Reducing Healthcare Costs
timeFrame: At Year 1
measure: Impact on Participant Microbiome
timeFrame: At Year 1
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Fairway
country: United States
facility: University of Kansas Cancer Center
state: Kansas
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: The University of Kansas Cancer Center
name: Anthony Sung, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Rudolphi JM, Berg RL. Mental health of agricultural adolescents and adults: Preliminary results of a five-year study. Front Public Health. 2023 Mar 2;11:1056487. doi: 10.3389/fpubh.2023.1056487. eCollection 2023.
citation: Pike NA, Poulsen MK, Woo MA. Validity of the Montreal Cognitive Assessment Screener in Adolescents and Young Adults With and Without Congenital Heart Disease. Nurs Res. 2017 May/Jun;66(3):222-230. doi: 10.1097/NNR.0000000000000192.
citation: Kreimeier S, Astrom M, Burstrom K, Egmar AC, Gusi N, Herdman M, Kind P, Perez-Sousa MA, Greiner W. EQ-5D-Y-5L: developing a revised EQ-5D-Y with increased response categories. Qual Life Res. 2019 Jul;28(7):1951-1961. doi: 10.1007/s11136-019-02115-x. Epub 2019 Feb 9.
citation: DeWalt DA, Gross HE, Gipson DS, Selewski DT, DeWitt EM, Dampier CD, Hinds PS, Huang IC, Thissen D, Varni JW. PROMIS((R)) pediatric self-report scales distinguish subgroups of children within and across six common pediatric chronic health conditions. Qual Life Res. 2015 Sep;24(9):2195-208. doi: 10.1007/s11136-015-0953-3. Epub 2015 Feb 26.
citation: Dee EC. Family and Caregiver Financial Toxicity Associated With Cancer-A Global, Inequitable, and Urgent Consideration. JAMA Netw Open. 2023 Jun 1;6(6):e2319317. doi: 10.1001/jamanetworkopen.2023.19317. No abstract available.
citation: Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
citation: Petrone BL, Aqeel A, Jiang S, Durand HK, Dallow EP, McCann JR, Dressman HK, Hu Z, Tenekjian CB, Yancy WS Jr, Lin PH, Scialla JJ, Seed PC, Rawls JF, Armstrong SC, Stevens J, David LA. Diversity of plant DNA in stool is linked to dietary quality, age, and household income. Proc Natl Acad Sci U S A. 2023 Jul 4;120(27):e2304441120. doi: 10.1073/pnas.2304441120. Epub 2023 Jun 27.
citation: Young HJ, Jenkins NT, Zhao Q, Mccully KK. Measurement of intramuscular fat by muscle echo intensity. Muscle Nerve. 2015 Dec;52(6):963-71. doi: 10.1002/mus.24656. Epub 2015 Sep 7.
citation: Reimers K, Reimers CD, Wagner S, Paetzke I, Pongratz DE. Skeletal muscle sonography: a correlative study of echogenicity and morphology. J Ultrasound Med. 1993 Feb;12(2):73-7. doi: 10.7863/jum.1993.12.2.73.
citation: Burton AM, Stock MS. Consistency of novel ultrasound equations for estimating percent intramuscular fat. Clin Physiol Funct Imaging. 2018 Jun 11. doi: 10.1111/cpf.12532. Online ahead of print.
citation: Tsuruta Y, Rogers LQ, Krontiras H, Grizzle WE, Fruge AD, Oster RA, Umphrey HR, Jones LW, Azrad M, Demark-Wahnefried W. Exploring effects of presurgical weight loss among women with stage 0-II breast cancer: protocol for a randomised controlled feasibility trial. BMJ Open. 2016 Sep 15;6(9):e012320. doi: 10.1136/bmjopen-2016-012320.
citation: Pekmezi DW, Crane TE, Oster RA, Rogers LQ, Hoenemeyer T, Farrell D, Cole WW, Wolin K, Badr H, Demark-Wahnefried W. Rationale and Methods for a Randomized Controlled Trial of a Dyadic, Web-Based, Weight Loss Intervention among Cancer Survivors and Partners: The DUET Study. Nutrients. 2021 Sep 29;13(10):3472. doi: 10.3390/nu13103472.
citation: Pekmezi D, Fontaine K, Rogers LQ, Pisu M, Martin MY, Schoenberger-Godwin YM, Oster RA, Kenzik K, Ivankova NV, Demark-Wahnefried W. Adapting MultiPLe behavior Interventions that eFfectively Improve (AMPLIFI) cancer survivor health: program project protocols for remote lifestyle intervention and assessment in 3 inter-related randomized controlled trials among survivors of obesity-related cancers. BMC Cancer. 2022 Apr 29;22(1):471. doi: 10.1186/s12885-022-09519-y.
citation: Demark-Wahnefried W, Jones LW, Snyder DC, Sloane RJ, Kimmick GG, Hughes DC, Badr HJ, Miller PE, Burke LE, Lipkus IM. Daughters and Mothers Against Breast Cancer (DAMES): main outcomes of a randomized controlled trial of weight loss in overweight mothers with breast cancer and their overweight daughters. Cancer. 2014 Aug 15;120(16):2522-34. doi: 10.1002/cncr.28761. Epub 2014 May 7.
citation: Demark-Wahnefried W, Nix JW, Hunter GR, Rais-Bahrami S, Desmond RA, Chacko B, Morrow CD, Azrad M, Fruge AD, Tsuruta Y, Ptacek T, Tully SA, Segal R, Grizzle WE. Feasibility outcomes of a presurgical randomized controlled trial exploring the impact of caloric restriction and increased physical activity versus a wait-list control on tumor characteristics and circulating biomarkers in men electing prostatectomy for prostate cancer. BMC Cancer. 2016 Feb 5;16:61. doi: 10.1186/s12885-016-2075-x.
citation: Conway JM, Ingwersen LA, Vinyard BT, Moshfegh AJ. Effectiveness of the US Department of Agriculture 5-step multiple-pass method in assessing food intake in obese and nonobese women. Am J Clin Nutr. 2003 May;77(5):1171-8. doi: 10.1093/ajcn/77.5.1171.
citation: Conway JM, Ingwersen LA, Moshfegh AJ. Accuracy of dietary recall using the USDA five-step multiple-pass method in men: an observational validation study. J Am Diet Assoc. 2004 Apr;104(4):595-603. doi: 10.1016/j.jada.2004.01.007.
citation: Freedman LS, Commins JM, Willett W, Tinker LF, Spiegelman D, Rhodes D, Potischman N, Neuhouser ML, Moshfegh AJ, Kipnis V, Baer DJ, Arab L, Prentice RL, Subar AF. Evaluation of the 24-Hour Recall as a Reference Instrument for Calibrating Other Self-Report Instruments in Nutritional Cohort Studies: Evidence From the Validation Studies Pooling Project. Am J Epidemiol. 2017 Jul 1;186(1):73-82. doi: 10.1093/aje/kwx039.
citation: Yin L, Lin X, Zhao Z, Li N, He X, Zhang M, Yang J, Guo Z, Li Z, Wang K, Weng M, Cong M, Li S, Li T, Ma H, Ba Y, Li W, Cui J, Liu J, Song C, Shi H, Xu H. Is hand grip strength a necessary supportive index in the phenotypic criteria of the GLIM-based diagnosis of malnutrition in patients with cancer? Support Care Cancer. 2021 Jul;29(7):4001-4013. doi: 10.1007/s00520-020-05975-z. Epub 2021 Jan 4.
citation: Jensen GL, Cederholm T, Correia MITD, Gonzalez MC, Fukushima R, Higashiguchi T, de Baptista GA, Barazzoni R, Blaauw R, Coats AJS, Crivelli A, Evans DC, Gramlich L, Fuchs-Tarlovsky V, Keller H, Llido L, Malone A, Mogensen KM, Morley JE, Muscaritoli M, Nyulasi I, Pirlich M, Pisprasert V, de van der Schueren M, Siltharm S, Singer P, Tappenden KA, Velasco N, Waitzberg DL, Yamwong P, Yu J, Compher C, Van Gossum A. GLIM Criteria for the Diagnosis of Malnutrition: A Consensus Report From the Global Clinical Nutrition Community. JPEN J Parenter Enteral Nutr. 2019 Jan;43(1):32-40. doi: 10.1002/jpen.1440. Epub 2018 Sep 2.
citation: Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
citation: Jim HS, Syrjala KL, Rizzo D. Supportive care of hematopoietic cell transplant patients. Biol Blood Marrow Transplant. 2012 Jan;18(1 Suppl):S12-6. doi: 10.1016/j.bbmt.2011.10.029.
citation: Smith PJ, Lew M, Lowder Y, Romero K, Thompson JC, Bohannon L, Pittman A, Artica A, Ramalingam S, Choi T, Gasparetto C, Horwitz M, Long G, Lopez R, Rizzieri D, Sarantopoulos S, Sullivan K, Chao N, Sung AD. Cognitive impairment in candidates for allogeneic hematopoietic stem cell transplantation. Bone Marrow Transplant. 2022 Jan;57(1):89-94. doi: 10.1038/s41409-021-01470-z. Epub 2021 Oct 19.
citation: Kang JM, Cho YS, Park S, Lee BH, Sohn BK, Choi CH, Choi JS, Jeong HY, Cho SJ, Lee JH, Lee JY. Montreal cognitive assessment reflects cognitive reserve. BMC Geriatr. 2018 Oct 30;18(1):261. doi: 10.1186/s12877-018-0951-8.
citation: van Hout B, Janssen MF, Feng YS, Kohlmann T, Busschbach J, Golicki D, Lloyd A, Scalone L, Kind P, Pickard AS. Interim scoring for the EQ-5D-5L: mapping the EQ-5D-5L to EQ-5D-3L value sets. Value Health. 2012 Jul-Aug;15(5):708-15. doi: 10.1016/j.jval.2012.02.008. Epub 2012 May 24.
citation: Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
citation: Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, Devellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai JS, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol. 2010 Nov;63(11):1179-94. doi: 10.1016/j.jclinepi.2010.04.011. Epub 2010 Aug 4.
citation: Aghdaee M, Gu Y, Sinha K, Parkinson B, Sharma R, Cutler H. Mapping the Patient-Reported Outcomes Measurement Information System (PROMIS-29) to EQ-5D-5L. Pharmacoeconomics. 2023 Feb;41(2):187-198. doi: 10.1007/s40273-022-01157-3. Epub 2022 Nov 7.
citation: Engel MD, Shelnutt KP, House LA, El Zein A, Mathews AE. Differences in Measured and Self-Categorized Food Security Status and Related Coping Strategies among College Students. Nutrients. 2022 Aug 30;14(17):3569. doi: 10.3390/nu14173569.
citation: Gibson CJ, Lindsley RC, Tchekmedyian V, Mar BG, Shi J, Jaiswal S, Bosworth A, Francisco L, He J, Bansal A, Morgan EA, Lacasce AS, Freedman AS, Fisher DC, Jacobsen E, Armand P, Alyea EP, Koreth J, Ho V, Soiffer RJ, Antin JH, Ritz J, Nikiforow S, Forman SJ, Michor F, Neuberg D, Bhatia R, Bhatia S, Ebert BL. Clonal Hematopoiesis Associated With Adverse Outcomes After Autologous Stem-Cell Transplantation for Lymphoma. J Clin Oncol. 2017 May 10;35(14):1598-1605. doi: 10.1200/JCO.2016.71.6712. Epub 2017 Jan 9.
citation: Gibson CJ, Kim HT, Zhao L, Murdock HM, Hambley B, Ogata A, Madero-Marroquin R, Wang S, Green L, Fleharty M, Dougan T, Cheng CA, Blumenstiel B, Cibulskis C, Tsuji J, Duran M, Gocke CD, Antin JH, Nikiforow S, DeZern AE, Chen YB, Ho VT, Jones RJ, Lennon NJ, Walt DR, Ritz J, Soiffer RJ, Gondek LP, Lindsley RC. Donor Clonal Hematopoiesis and Recipient Outcomes After Transplantation. J Clin Oncol. 2022 Jan 10;40(2):189-201. doi: 10.1200/JCO.21.02286. Epub 2021 Nov 18.
citation: Fall-Dickson JM, Pavletic SZ, Mays JW, Schubert MM. Oral Complications of Chronic Graft-Versus-Host Disease. J Natl Cancer Inst Monogr. 2019 Aug 1;2019(53):lgz007. doi: 10.1093/jncimonographs/lgz007.
citation: Garios RS, Oliveira PM, Aguiar AS, Luquetti SCPD. Caloric and protein intake in different periods of hospitalization of patients undergoing hematopoietic stem cell transplantation. Hematol Transfus Cell Ther. 2018 Oct-Dec;40(4):332-338. doi: 10.1016/j.htct.2018.02.003. Epub 2018 Apr 18.
citation: Robin M, Porcher R, Ades L, Boissel N, Raffoux E, Xhaard A, Larghero J, Gardin C, Himberlin C, Delmer A, Fenaux P, Dombret H, Socie G, Peffault de Latour R. Matched unrelated or matched sibling donors result in comparable outcomes after non-myeloablative HSCT in patients with AML or MDS. Bone Marrow Transplant. 2013 Oct;48(10):1296-301. doi: 10.1038/bmt.2013.50. Epub 2013 Apr 15.
citation: Horan JT, Logan BR, Agovi-Johnson MA, Lazarus HM, Bacigalupo AA, Ballen KK, Bredeson CN, Carabasi MH, Gupta V, Hale GA, Khoury HJ, Juckett MB, Litzow MR, Martino R, McCarthy PL, Smith FO, Rizzo JD, Pasquini MC. Reducing the risk for transplantation-related mortality after allogeneic hematopoietic cell transplantation: how much progress has been made? J Clin Oncol. 2011 Mar 1;29(7):805-13. doi: 10.1200/JCO.2010.32.5001. Epub 2011 Jan 10.
citation: Gooley TA, Chien JW, Pergam SA, Hingorani S, Sorror ML, Boeckh M, Martin PJ, Sandmaier BM, Marr KA, Appelbaum FR, Storb R, McDonald GB. Reduced mortality after allogeneic hematopoietic-cell transplantation. N Engl J Med. 2010 Nov 25;363(22):2091-101. doi: 10.1056/NEJMoa1004383.
citation: Muscaritoli M, Lucia S, Farcomeni A, Lorusso V, Saracino V, Barone C, Plastino F, Gori S, Magarotto R, Carteni G, Chiurazzi B, Pavese I, Marchetti L, Zagonel V, Bergo E, Tonini G, Imperatori M, Iacono C, Maiorana L, Pinto C, Rubino D, Cavanna L, Di Cicilia R, Gamucci T, Quadrini S, Palazzo S, Minardi S, Merlano M, Colucci G, Marchetti P; PreMiO Study Group. Prevalence of malnutrition in patients at first medical oncology visit: the PreMiO study. Oncotarget. 2017 Aug 10;8(45):79884-79896. doi: 10.18632/oncotarget.20168. eCollection 2017 Oct 3.
citation: Raber M, Jackson A, Basen-Engquist K, Bradley C, Chambers S, Gany FM, Halbert CH, Lindau ST, Perez-Escamilla R, Seligman H. Food Insecurity Among People With Cancer: Nutritional Needs as an Essential Component of Care. J Natl Cancer Inst. 2022 Dec 8;114(12):1577-1583. doi: 10.1093/jnci/djac135.
citation: Patel KG, Borno HT, Seligman HK. Food insecurity screening: A missing piece in cancer management. Cancer. 2019 Oct 15;125(20):3494-3501. doi: 10.1002/cncr.32291. Epub 2019 Jul 9. No abstract available.
citation: Hanson KL, Connor LM. Food insecurity and dietary quality in US adults and children: a systematic review. Am J Clin Nutr. 2014 Aug;100(2):684-92. doi: 10.3945/ajcn.114.084525. Epub 2014 Jun 18.
citation: Silverman J, Krieger J, Kiefer M, Hebert P, Robinson J, Nelson K. The Relationship Between Food Insecurity and Depression, Diabetes Distress and Medication Adherence Among Low-Income Patients with Poorly-Controlled Diabetes. J Gen Intern Med. 2015 Oct;30(10):1476-80. doi: 10.1007/s11606-015-3351-1. Epub 2015 Apr 28.
citation: Gundersen C, Ziliak JP. Food Insecurity And Health Outcomes. Health Aff (Millwood). 2015 Nov;34(11):1830-9. doi: 10.1377/hlthaff.2015.0645.
citation: Reeder N, Tolar-Peterson T, Bailey RH, Cheng WH, Evans MW Jr. Food Insecurity and Depression among US Adults: NHANES 2005-2016. Nutrients. 2022 Jul 27;14(15):3081. doi: 10.3390/nu14153081.
citation: Zenk 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.
citation: Afulani P, Herman D, Coleman-Jensen A, Harrison GG. Food Insecurity and Health Outcomes Among Older Adults: The Role of Cost-Related Medication Underuse. J Nutr Gerontol Geriatr. 2015;34(3):319-42. doi: 10.1080/21551197.2015.1054575.
citation: Holmes ZC, Tang H, Liu C, Bush A, Neubert BC, Jiao Y, Covington M, Cardona DM, Kirtley MC, Chen BJ, Chao NJ, David LA, Sung AD. Prebiotic galactooligosaccharides interact with mouse gut microbiota to attenuate acute graft-versus-host disease. Blood. 2022 Nov 24;140(21):2300-2304. doi: 10.1182/blood.2021015178.
citation: Thaiss CA, Zmora N, Levy M, Elinav E. The microbiome and innate immunity. Nature. 2016 Jul 7;535(7610):65-74. doi: 10.1038/nature18847.
citation: Honda K, Littman DR. The microbiota in adaptive immune homeostasis and disease. Nature. 2016 Jul 7;535(7610):75-84. doi: 10.1038/nature18848.
citation: Mager LF, Burkhard R, Pett N, Cooke NCA, Brown K, Ramay H, Paik S, Stagg J, Groves RA, Gallo M, Lewis IA, Geuking MB, McCoy KD. Microbiome-derived inosine modulates response to checkpoint inhibitor immunotherapy. Science. 2020 Sep 18;369(6510):1481-1489. doi: 10.1126/science.abc3421. Epub 2020 Aug 13.
citation: Zheng L, Kelly CJ, Battista KD, Schaefer R, Lanis JM, Alexeev EE, Wang RX, Onyiah JC, Kominsky DJ, Colgan SP. Microbial-Derived Butyrate Promotes Epithelial Barrier Function through IL-10 Receptor-Dependent Repression of Claudin-2. J Immunol. 2017 Oct 15;199(8):2976-2984. doi: 10.4049/jimmunol.1700105. Epub 2017 Sep 11.
citation: Kelly CJ, Zheng L, Campbell EL, Saeedi B, Scholz CC, Bayless AJ, Wilson KE, Glover LE, Kominsky DJ, Magnuson A, Weir TL, Ehrentraut SF, Pickel C, Kuhn KA, Lanis JM, Nguyen V, Taylor CT, Colgan SP. Crosstalk between Microbiota-Derived Short-Chain Fatty Acids and Intestinal Epithelial HIF Augments Tissue Barrier Function. Cell Host Microbe. 2015 May 13;17(5):662-71. doi: 10.1016/j.chom.2015.03.005. Epub 2015 Apr 9.
citation: Metzger KE, Rucker Y, Callaghan M, Churchill M, Jovanovic BD, Zembower TR, Bolon MK. The burden of mucosal barrier injury laboratory-confirmed bloodstream infection among hematology, oncology, and stem cell transplant patients. Infect Control Hosp Epidemiol. 2015 Feb;36(2):119-24. doi: 10.1017/ice.2014.38.
citation: Dandoy CE, Kim S, Chen M, Ahn KW, Ardura MI, Brown V, Chhabra S, Diaz MA, Dvorak C, Farhadfar N, Flagg A, Ganguly S, Hale GA, Hashmi SK, Hematti P, Martino R, Nishihori T, Nusrat R, Olsson RF, Rotz SJ, Sung AD, Perales MA, Lindemans CA, Komanduri KV, Riches ML. Incidence, Risk Factors, and Outcomes of Patients Who Develop Mucosal Barrier Injury-Laboratory Confirmed Bloodstream Infections in the First 100 Days After Allogeneic Hematopoietic Stem Cell Transplant. JAMA Netw Open. 2020 Jan 3;3(1):e1918668. doi: 10.1001/jamanetworkopen.2019.18668.
citation: Sung AD, Chao NJ. Concise review: acute graft-versus-host disease: immunobiology, prevention, and treatment. Stem Cells Transl Med. 2013 Jan;2(1):25-32. doi: 10.5966/sctm.2012-0115. Epub 2012 Dec 19.
citation: Campbell SC, Wisniewski PJ, Noji M, McGuinness LR, Haggblom MM, Lightfoot SA, Joseph LB, Kerkhof LJ. The Effect of Diet and Exercise on Intestinal Integrity and Microbial Diversity in Mice. PLoS One. 2016 Mar 8;11(3):e0150502. doi: 10.1371/journal.pone.0150502. eCollection 2016.
citation: Bressa C, Bailen-Andrino M, Perez-Santiago J, Gonzalez-Soltero R, Perez M, Montalvo-Lominchar MG, Mate-Munoz JL, Dominguez R, Moreno D, Larrosa M. Differences in gut microbiota profile between women with active lifestyle and sedentary women. PLoS One. 2017 Feb 10;12(2):e0171352. doi: 10.1371/journal.pone.0171352. eCollection 2017.
citation: Evans CC, LePard KJ, Kwak JW, Stancukas MC, Laskowski S, Dougherty J, Moulton L, Glawe A, Wang Y, Leone V, Antonopoulos DA, Smith D, Chang EB, Ciancio MJ. Exercise prevents weight gain and alters the gut microbiota in a mouse model of high fat diet-induced obesity. PLoS One. 2014 Mar 26;9(3):e92193. doi: 10.1371/journal.pone.0092193. eCollection 2014.
citation: Denou E, Marcinko K, Surette MG, Steinberg GR, Schertzer JD. High-intensity exercise training increases the diversity and metabolic capacity of the mouse distal gut microbiota during diet-induced obesity. Am J Physiol Endocrinol Metab. 2016 Jun 1;310(11):E982-93. doi: 10.1152/ajpendo.00537.2015. Epub 2016 Apr 26.
citation: Stein-Thoeringer CK, Nichols KB, Lazrak A, Docampo MD, Slingerland AE, Slingerland JB, Clurman AG, Armijo G, Gomes ALC, Shono Y, Staffas A, Burgos da Silva M, Devlin SM, Markey KA, Bajic D, Pinedo R, Tsakmaklis A, Littmann ER, Pastore A, Taur Y, Monette S, Arcila ME, Pickard AJ, Maloy M, Wright RJ, Amoretti LA, Fontana E, Pham D, Jamal MA, Weber D, Sung AD, Hashimoto D, Scheid C, Xavier JB, Messina JA, Romero K, Lew M, Bush A, Bohannon L, Hayasaka K, Hasegawa Y, Vehreschild MJGT, Cross JR, Ponce DM, Perales MA, Giralt SA, Jenq RR, Teshima T, Holler E, Chao NJ, Pamer EG, Peled JU, van den Brink MRM. Lactose drives Enterococcus expansion to promote graft-versus-host disease. Science. 2019 Nov 29;366(6469):1143-1149. doi: 10.1126/science.aax3760.
citation: Peled JU, Gomes ALC, Devlin SM, Littmann ER, Taur Y, Sung AD, Weber D, Hashimoto D, Slingerland AE, Slingerland JB, Maloy M, Clurman AG, Stein-Thoeringer CK, Markey KA, Docampo MD, Burgos da Silva M, Khan N, Gessner A, Messina JA, Romero K, Lew MV, Bush A, Bohannon L, Brereton DG, Fontana E, Amoretti LA, Wright RJ, Armijo GK, Shono Y, Sanchez-Escamilla M, Castillo Flores N, Alarcon Tomas A, Lin RJ, Yanez San Segundo L, Shah GL, Cho C, Scordo M, Politikos I, Hayasaka K, Hasegawa Y, Gyurkocza B, Ponce DM, Barker JN, Perales MA, Giralt SA, Jenq RR, Teshima T, Chao NJ, Holler E, Xavier JB, Pamer EG, van den Brink MRM. Microbiota as Predictor of Mortality in Allogeneic Hematopoietic-Cell Transplantation. N Engl J Med. 2020 Feb 27;382(9):822-834. doi: 10.1056/NEJMoa1900623.
citation: Khan N, Lindner S, Gomes ALC, Devlin SM, Shah GL, Sung AD, Sauter CS, Landau HJ, Dahi PB, Perales MA, Chung DJ, Lesokhin AM, Dai A, Clurman A, Slingerland JB, Slingerland AE, Brereton DG, Giardina PA, Maloy M, Armijo GK, Rondon-Clavo C, Fontana E, Bohannon L, Ramalingam S, Bush AT, Lew MV, Messina JA, Littmann E, Taur Y, Jenq RR, Chao NJ, Giralt S, Markey KA, Pamer EG, van den Brink MRM, Peled JU. Fecal microbiota diversity disruption and clinical outcomes after auto-HCT: a multicenter observational study. Blood. 2021 Mar 18;137(11):1527-1537. doi: 10.1182/blood.2020006923.
citation: Guo H, Chou WC, Lai Y, Liang K, Tam JW, Brickey WJ, Chen L, Montgomery ND, Li X, Bohannon LM, Sung AD, Chao NJ, Peled JU, Gomes ALC, van den Brink MRM, French MJ, Macintyre AN, Sempowski GD, Tan X, Sartor RB, Lu K, Ting JPY. Multi-omics analyses of radiation survivors identify radioprotective microbes and metabolites. Science. 2020 Oct 30;370(6516):eaay9097. doi: 10.1126/science.aay9097.
citation: Holland AE, Spruit MA, Troosters T, Puhan MA, Pepin V, Saey D, McCormack MC, Carlin BW, Sciurba FC, Pitta F, Wanger J, MacIntyre N, Kaminsky DA, Culver BH, Revill SM, Hernandes NA, Andrianopoulos V, Camillo CA, Mitchell KE, Lee AL, Hill CJ, Singh SJ. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1428-46. doi: 10.1183/09031936.00150314. Epub 2014 Oct 30.
citation: Enright PL, Sherrill DL. Reference equations for the six-minute walk in healthy adults. Am J Respir Crit Care Med. 1998 Nov;158(5 Pt 1):1384-7. doi: 10.1164/ajrccm.158.5.9710086.
citation: Enright PL. The six-minute walk test. Respir Care. 2003 Aug;48(8):783-5.
citation: Bieniek J, Wilczynski K, Szewieczek J. Fried frailty phenotype assessment components as applied to geriatric inpatients. Clin Interv Aging. 2016 Apr 22;11:453-9. doi: 10.2147/CIA.S101369. eCollection 2016.
citation: Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
citation: de Souza JA, Yap BJ, Wroblewski K, Blinder V, Araujo FS, Hlubocky FJ, Nicholas LH, O'Connor JM, Brockstein B, Ratain MJ, Daugherty CK, Cella D. Measuring financial toxicity as a clinically relevant patient-reported outcome: The validation of the COmprehensive Score for financial Toxicity (COST). Cancer. 2017 Feb 1;123(3):476-484. doi: 10.1002/cncr.30369. Epub 2016 Oct 7.
citation: de Souza JA, Yap BJ, Hlubocky FJ, Wroblewski K, Ratain MJ, Cella D, Daugherty CK. The development of a financial toxicity patient-reported outcome in cancer: The COST measure. Cancer. 2014 Oct 15;120(20):3245-53. doi: 10.1002/cncr.28814. Epub 2014 Jun 20.
citation: Billioux A, Conway PH, Alley DE. Addressing Population Health: Integrators in the Accountable Health Communities Model. JAMA. 2017 Nov 21;318(19):1865-1866. doi: 10.1001/jama.2017.15063. No abstract available.
citation: Alley DE, Asomugha CN, Conway PH, Sanghavi DM. Accountable Health Communities--Addressing Social Needs through Medicare and Medicaid. N Engl J Med. 2016 Jan 7;374(1):8-11. doi: 10.1056/NEJMp1512532. Epub 2016 Jan 5. No abstract available.
citation: Lew MV, Ren Y, Lowder YP, Siamakpour-Reihani S, Ramalingam S, Romero KM, Thompson JC, Bohannon LM, McIntyre J, Tang H, Van Opstal J, Johnson E, Cohen HJ, Bartlett DB, Pastva AM, Morey M, Hall KS, Smith P, Peters KB, Somers TJ, Kelleher S, Smith SK, Wischmeyer PE, Lin PH, Wood WA, Thorpe G, Minor K, Wiggins K, Hennig T, Helms T, Welch R, Matthews B, Liu J, Burleson J, Aberant T, Engemann AK, Henshall B, Darby M, Proch C, Dellascio M, Pittman A, Suminguit J, Choi T, Gasparetto C, Long GD, Lopez RD, Sarantopoulos S, Horwitz ME, Chao NJ, Sung AD. Geriatric Assessment Reveals Actionable Impairments in Hematopoietic Stem Cell Transplantation Candidates Age 18 to 80 Years. Transplant Cell Ther. 2022 Aug;28(8):498.e1-498.e9. doi: 10.1016/j.jtct.2022.05.018. Epub 2022 May 17.
citation: Broder MS, Quock TP, Chang E, Reddy SR, Agarwal-Hashmi R, Arai S, Villa KF. The Cost of Hematopoietic Stem-Cell Transplantation in the United States. Am Health Drug Benefits. 2017 Oct;10(7):366-374.