[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07076004":3,"trial-entities:NCT07076004":103,"trial-summary:NCT07076004":107},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":44,"secondary_outcomes":48,"sex":65,"minimum_age":66,"maximum_age":67,"healthy_volunteers":68,"eligibility_criteria":69,"std_ages":83,"locations":86,"central_contacts":96,"overall_officials":97,"references":101,"see_also_links":102},"NCT07076004","2000039692","Nourishing Hope: The Impact of Nutrition in Cancer Treatment and Recovery in Maine","ACTIVE_NOT_RECRUITING","2027-01-17","2026-07","2026-07-28","2025-07-30","Yale University","OTHER",false,"The primary objective of this study is to determine the effect of a 6-month pilot randomized controlled trial of medically tailored grocery delivery plus nutrition counseling vs. medically tailored grocery delivery alone vs. standard of care (with delayed grocery delivery alone) among 100 individuals with any stage and type cancer who reside in Maine on change in diet quality from baseline to 6-months.\n\nThe secondary objective is to assess the benefits of the intervention on change from baseline to 6-months on self-reported healthcare utilization (e.g., hospitalizations, emergency room visits), malnutrition, cancer-treatment related symptoms, food insecurity, quality of life, and financial toxicity. We will also evaluate feasibility and acceptability of the intervention in the target population.","The purpose of this study is to assess the effect of a 6-month intervention of medically tailored groceries plus nutrition counseling vs. medically tailored groceries alone vs. standard of care on diet and health outcomes among 100 cancer survivors who reside in Maine. This project will be conducted in partnership with the Christine B. Foundation which has been delivering medically tailored groceries to cancer survivors in Maine since 2020, but has not yet evaluated the impact of this nutrition program on important health outcomes in people living with cancer. The eligibility criteria matched the population of cancer survivors currently served by the Christine B. Foundation as we are testing the effect of their services on health-related outcomes in their target population. Given medically tailored meals and groceries have conferred health benefits in other patient populations, but there is limited research among cancer survivors, this highly innovative study and could provide evidence on the potential benefits of this type of nutrition intervention specifically for cancer survivors.",[18],"Cancer",[20,21],"Medically tailored grocery delivery","Diet Quality","INTERVENTIONAL","SUPPORTIVE_CARE",[25],"NA",{"count":27,"type":28},100,"ESTIMATED",[30,35,40],{"type":31,"name":32,"description":33,"armGroupLabels":34},"BEHAVIORAL","Medically Tailored Grocery Plus Nutrition Counseling Group","Weekly delivery of medically tailored groceries plus 8 remote nutritional counselling sessions.",[32],{"type":31,"name":36,"description":37,"armGroupLabels":38},"Experimental: Medically Tailored Grocery Group","Weekly delivery of medically tailored groceries.",[39],"Medically Tailored Grocery Group",{"type":31,"name":41,"description":42,"armGroupLabels":43},"Standard of Care Group with Delayed Medically Tailored Grocery Delivery","Option to pick up fresh produce weekly from participating clinics. Medically tailored grocery delivery will be available for 6 months beginning at the end of the study.",[41],[45],{"measure":21,"description":46,"timeFrame":47},"Recent diet will be assessed via food frequency questionnaire (FFQ). Diet quality will be calculated using the HEI-2020; range of 0 - 100, higher score indicating better diet quality.","Change from baseline to 6 months",[49,52,55,58,62],{"measure":50,"description":51,"timeFrame":47},"Food Insecurity","United Stated Department of Agriculture 6-item questionnaire; range of 0-6, higher score indicating lower food security.",{"measure":53,"description":54,"timeFrame":47},"Health Related Quality of Life","12-item Short Form Survey (SF-12) will be used to generate the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Using norm based scores, above 50 indicate a better-than-average health-related quality of life.",{"measure":56,"description":57,"timeFrame":47},"Cancer-Treatment Related Symptoms","Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Count of number of symptoms.",{"measure":59,"description":60,"timeFrame":61},"Healthcare Utilization","Self-reported visits and admissions to emergency rooms, urgent care clinics, and in-patient facilities.","Number from baseline to 6 months",{"measure":63,"description":64,"timeFrame":47},"Malnutrition","Patient-Generated Subjective Global Assessment (PG-SGA); range of 0-33, higher score indicating greater likelihood of malnutrition.","ALL","18 Years",null,true,{"inclusion":70,"exclusion":74,"raw_text":82},[71,72,73],"18 years of age or older","Ever been diagnosed with cancer","Reside Hancock, Penobscot, Washington or Piscataquis county in Maine for the next 6 months",[75,76,77,78,79,80,81],"Seeing a dietitian regularly (at least once every two weeks)","Planned long-term inpatient cancer treatment","Receiving nutrition via IV also known as total parenteral nutrition","Getting nutrition through a feeding tube","Drinking more than 3 bottles of liquid meal replacements, such as Ensure, per day","Received grocery delivery or grocery (not produce only) pick-up from the Christine B. Foundation in the past 3 months.","Those with reduced mental capacity and unable to understand all the components of the study, including the details of randomization.","Inclusion Criteria:\n\n* 18 years of age or older\n* Ever been diagnosed with cancer\n* Reside Hancock, Penobscot, Washington or Piscataquis county in Maine for the next 6 months\n\nExclusion Criteria:\n\n* Seeing a dietitian regularly (at least once every two weeks)\n* Planned long-term inpatient cancer treatment\n* Receiving nutrition via IV also known as total parenteral nutrition\n* Getting nutrition through a feeding tube\n* Drinking more than 3 bottles of liquid meal replacements, such as Ensure, per day\n* Received grocery delivery or grocery (not produce only) pick-up from the Christine B. Foundation in the past 3 months.\n* Those with reduced mental capacity and unable to understand all the components of the study, including the details of randomization.",[84,85],"ADULT","OLDER_ADULT",[87],{"facility":88,"city":89,"state":90,"zip":91,"country":92,"geoPoint":93},"Yale School of Public Health","New Haven","Connecticut","06510","United States",{"lat":94,"lon":95},41.30815,-72.92816,[],[98],{"name":99,"affiliation":12,"role":100},"Leah M Ferrucci, PhD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":104,"biomarkers":106},[105],"Malignant Neoplasm",[],{"nct_id":4,"found":68,"summary":108,"prompt_version":118},{"design":109,"status":110,"heading":111,"summary":112,"follow_up":113,"word_count":114,"commitments":115,"compensation":116,"drugs_mentioned":117},"This is an interventional study that will enroll 100 participants. It compares three different approaches to nutrition support for people with cancer.","completed","Nourishing Hope: Nutrition for Cancer Treatment and Recovery in Maine","This study, called \"Nourishing Hope,\" is looking at how different nutrition support can help people with cancer in Maine. It's testing three approaches: weekly delivery of medically tailored groceries plus 8 nutrition counseling sessions; weekly delivery of medically tailored groceries alone; or standard care, which includes the option to pick up fresh produce weekly from clinics, with medically tailored grocery delivery available later. The study aims to see how these interventions affect your diet quality over 6 months. You might be able to join if you are 18 or older, have been diagnosed with cancer, and live in Hancock, Penobscot, Washington, or Piscataquis county in Maine for the next 6 months. The study is currently unclear on its recruitment status and plans to enroll 100 participants.","Participants' diet quality will be measured at 6 months from the start of the study.",126,"If you join, you would receive weekly grocery deliveries and potentially 8 remote nutrition counseling sessions, or have the option to pick up fresh produce weekly. The study lasts for 6 months.","Not stated in the trial record.",[],"v2"]