Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2025-12-31 @ 1:41 PM
Study NCT ID:
NCT06802406
Status:
RECRUITING
Last Update Posted:
2025-04-22
First Post:
2024-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutrition OUtReach In Systems of Healthcare
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 210}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2029-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-16', 'studyFirstSubmitDate': '2024-12-11', 'studyFirstSubmitQcDate': '2025-01-24', 'lastUpdatePostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Muscle Health', 'timeFrame': 'At Day 100 and at Year 1', 'description': 'Muscle health as assessed by MuscleSound, which quantifies changes in intramuscular adipose tissue (kg).'}, {'measure': 'Muscle Health', 'timeFrame': 'At Day 100 and at Year 1', 'description': 'Muscle health as assessed by MuscleSound, which quantifies changes in glycogen stores (g).'}, {'measure': 'Muscle Health', 'timeFrame': 'At Day 100 and at Year 1', 'description': 'Muscle health as assessed by MuscleSound, which quantifies changes in muscle wasting using the Skeletal Muscle Index (SMI), with a higher number representing greater muscle mass.'}, {'measure': 'Muscle Health', 'timeFrame': 'At Day 100 and at Year 1', 'description': 'Muscle health as assessed by MuscleSound, which quantifies changes in the presence or absence of sarcopenia.'}, {'measure': 'Accelerated Aging', 'timeFrame': 'At Year 1', 'description': 'Accelerated aging as measured by evaluation of blood biomarkers in plasma and peripheral blood mononuclear cells.'}, {'measure': 'Home Food Bank Utilization', 'timeFrame': 'At Year 1', 'description': 'Home food bank utilization as measured by percentage of patients reporting use of food bank after intervention.'}, {'measure': 'Impact of NOURISH on Reducing Healthcare Costs', 'timeFrame': 'At Year 1', 'description': 'Impact of NOURISH on all-cause medical resource use and associated costs as measured by the Functional Assessment of 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.'}, {'measure': 'Impact of NOURISH on Reducing Healthcare Costs', 'timeFrame': 'At Year 1', 'description': 'Impact of NOURISH on costs of resources to support the NOURISH intervention as measured by the study budget.'}, {'measure': 'Impact of NOURISH on Reducing Healthcare Costs', 'timeFrame': 'At Year 1', 'description': 'Impact of NOURISH on preference-weighted measure of health status, as measured by the Euro Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L).'}, {'measure': 'Impact on Participant Microbiome', 'timeFrame': 'At Year 1', 'description': 'Impact on participant microbiome as measured by 16S and/or shotgun sequencing.'}], 'primaryOutcomes': [{'measure': 'Peri-Transplant and Cell Therapy Malnutrition', 'timeFrame': 'Through Day 100', 'description': 'Assessed by Global Leader Initiative on Malnutrition and confirmed by a dietitian'}], 'secondaryOutcomes': [{'measure': 'Peri-TCT Incidence of Infections', 'timeFrame': 'Through Day 100', 'description': 'Incidence and subtypes (blood stream, respiratory, or other) of infections captured as standard of care.'}, {'measure': 'Peri-TCT Incidence of Acute Graft-vs-Host-Disease', 'timeFrame': 'Through Day 180', 'description': 'Incidence of acute GVHD captured as standard of care.'}, {'measure': 'Peri-TCT Incidence of Chronic Graft-vs-Host Disease', 'timeFrame': 'Through Year 1', 'description': 'Incidence of chronic GVHD captured as standard of care.'}, {'measure': 'Incidence of Relapse', 'timeFrame': 'Through Year 1', 'description': 'Incidence of relapse captured as standard of care.'}, {'measure': 'Incidence of Treatment-Related Mortality', 'timeFrame': 'Through End of Study', 'description': 'Incidence of treatment-related mortality captured as standard of care.'}, {'measure': 'Overall Survival', 'timeFrame': 'Through Year 1', 'description': 'Overall survival captured as standard of care.'}, {'measure': 'Quality of Life (PROMIS-29 Score)', 'timeFrame': 'At Day 100 and at Year 1', 'description': '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.'}, {'measure': 'Financial Toxicity', 'timeFrame': 'Day 100 and Year 1', 'description': '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.'}, {'measure': 'Physical Function', 'timeFrame': 'At Day 100 and at Year 1', 'description': 'Physical function measured by average 6 minute walk test distance.'}, {'measure': 'Cognitive Function', 'timeFrame': 'At Day 100 and at Year 1', 'description': '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.'}, {'measure': 'Mental Health', 'timeFrame': 'At Day 100 and at Year 1', 'description': '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.'}, {'measure': 'Dietary Habits and Consumption', 'timeFrame': 'At Year 1', 'description': '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.'}, {'measure': 'Dietary Habits and Consumption', 'timeFrame': 'At Year 1', 'description': '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.'}, {'measure': 'Dietary Habits and Consumption', 'timeFrame': 'At Year 1', 'description': '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.'}, {'measure': 'Dietary Habits and Consumption', 'timeFrame': 'At Year 1', 'description': '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.'}, {'measure': 'Dietary Habits and Consumption', 'timeFrame': 'At Year 1', 'description': '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.'}, {'measure': 'Impact on Food Insecurity', 'timeFrame': 'At Year 1', 'description': '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.'}, {'measure': 'Social Determinants of Health', 'timeFrame': 'At workup and at Year 1', 'description': '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.'}, {'measure': 'Fried Frailty', 'timeFrame': 'At Day 100 and at Year 1', 'description': 'Fried Frailty measured by percentage of patients meeting 3 or more of the diagnostic criteria for frailty.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nutrition, food insecurity'], 'conditions': ['ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION', 'Autologous Haemopoietic Stem Cell Transplant', 'CAR-T Cell Therapy', 'Food Insecurity']}, 'referencesModule': {'references': [{'pmid': '34255351', 'type': 'BACKGROUND', '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.'}, {'pmid': '33239790', 'type': 'BACKGROUND', '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.'}, {'pmid': '25021423', 'type': 'BACKGROUND', '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."}, {'pmid': '38127876', 'type': 'BACKGROUND', '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.'}, {'pmid': '19897823', 'type': 'BACKGROUND', 'citation': 'Faul F, Erdfelder E, Buchner A, Lang AG. Statistical power analyses using G*Power 3.1: tests for correlation and regression analyses. 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Am Health Drug Benefits. 2017 Oct;10(7):366-374.'}], 'seeAlsoLinks': [{'url': 'https://health.gov/healthypeople/priority-areas/social-determinants-health/literature-summaries/food-insecurity', 'label': 'Healthy People 2030 - Food Insecurity'}, {'url': 'https://healthcare.rti.org/insights/food-insecurity-adult-health', 'label': 'The Impact Of Food Insecurity On Adult Health \\& Well-Being'}, {'url': 'https://proof.utoronto.ca/food-insecurity/what-are-the-implications-of-food-insecurity-for-health-and-health-care/', 'label': 'What are the implications of food insecurity for health and health care?'}, {'url': 'https://www.feedingamerica.org/hunger-in-america/impact-of-hunger', 'label': 'Compromises and Coping Strategies 2014'}, {'url': 'https://frac.org/wp-content/uploads/hunger-health-impact-poverty-food-insecurity-health-well-being.pdf', 'label': 'The Impact of Poverty, Food Insecurity, and Poor Nutrition on Health and Well-Being'}]}, 'descriptionModule': {'briefSummary': "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.\n\nBy 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.", 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Planning to receive transplant or cell therapy\n* Screen positive for food insecurity by answering "often true" or "sometimes true" to one of the following:\n\n * "Within the past 12 months, you worried that your food would run out before you got money to buy more,"\n * "Within the past 12 months, the food you bought just didn\'t last and you didn\'t have money to get more."\n* Age 8 - 80\n* Able to read/write English or Spanish (many patient-reported outcome measures lack validated translations in other languages)\n\nExclusion Criteria:\n\n* Patients who do not tolerate oral nutrition at the time of study enrollment'}, 'identificationModule': {'nctId': 'NCT06802406', 'acronym': 'NOURISH', 'briefTitle': 'Nutrition OUtReach In Systems of Healthcare', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Nutrition OUtReach In Systems of Healthcare', 'orgStudyIdInfo': {'id': 'NOURISH'}, 'secondaryIdInfos': [{'id': 'R01NR021468', 'link': 'https://reporter.nih.gov/quickSearch/R01NR021468', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Information Group', 'description': 'These participants will receive information on their local food banks according to standard of care.'}, {'type': 'EXPERIMENTAL', 'label': 'Food Bags Group', 'description': 'Patients 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.', 'interventionNames': ['Other: Food Bags']}], 'interventions': [{'name': 'Food Bags', 'type': 'OTHER', 'otherNames': ['NOURISH'], 'description': '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.', 'armGroupLabels': ['Food Bags Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Andrew Rezvani, MD', 'role': 'CONTACT', 'email': 'arezvani@stanford.edu', 'phone': '650-723-0822'}, {'name': 'Andrew Rezvani, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '66205', 'city': 'Fairway', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anthony Sung, MD', 'role': 'CONTACT', 'email': 'asung2@kumc.edu', 'phone': '913-588-1227'}, {'name': 'Anthony Sung, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Kansas Cancer Center', 'geoPoint': {'lat': 39.02223, 'lon': -94.6319}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jonathan Peled, MD', 'role': 'CONTACT', 'email': 'peledj@mskcc.org', 'phone': '646-888-2105'}, {'name': 'Jonathan Peled, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kris Mahadeo, MD', 'role': 'CONTACT', 'email': 'kris.mahadeo@duke.edu', 'phone': '919-668-1100'}, {'name': 'Kris Mahadeo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'centralContacts': [{'name': 'Anthony Sung, MD', 'role': 'CONTACT', 'email': 'asung2@kumc.edu', 'phone': '913-588-1227'}], 'overallOfficials': [{'name': 'Anthony Sung, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Kansas Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Duke University', 'class': 'OTHER'}, {'name': 'Stanford University', 'class': 'OTHER'}, {'name': 'Memorial Sloan-Kettering Cancer Center, USA', 'class': 'UNKNOWN'}, {'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}