[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598506":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":35,"centralContacts":40,"locations":46,"responsibleParty":68,"collaborators":35,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":35,"enrollmentInfo":80,"targetDuration":35,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":94,"overallStatus":48,"whyStopped":35,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"University of Vermont Medical Center","OTHER",[8,13,16,20,23,26],{"label":9,"type":10,"description":9,"interventionNames":11},"Rural, Remote, Low-Intensity","EXPERIMENTAL",[12],"Behavioral: Intensity of Nutritional Intervention",{"label":14,"type":10,"description":14,"interventionNames":15},"Rural, Remote, High-Intensity",[12],{"label":17,"type":10,"description":17,"interventionNames":18},"Urban, Remote, Low-Intensity",[12,19],"Behavioral: Remote or In-Person",{"label":21,"type":10,"description":21,"interventionNames":22},"Urban, Remote, High-Intensity",[12,19],{"label":24,"type":10,"description":24,"interventionNames":25},"Urban, In-Person, Low-Intensity",[12,19],{"label":27,"type":10,"description":27,"interventionNames":28},"Urban, In-Person, High-Intensity",[12,19],[30,36],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"BEHAVIORAL","Intensity of Nutritional Intervention","Participants will either receive High or Low intensity nutritional support.",[14,9,27,24,21,17],null,{"type":31,"name":37,"description":38,"armGroupLabels":39,"otherNames":35},"Remote or In-Person","Patients will either receive their support in-person or remotely.",[27,24,21,17],[41],{"name":42,"role":43,"phone":44,"phoneExt":35,"email":45},"Randall F Holcombe, MD","CONTACT","1 (802) 656-2021","Randall.holcombe@med.uvm.edu",[47],{"facility":5,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"RECRUITING","Burlington","Vermont","05401","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-73.21207,44.47588,{"lat":58,"lon":57},[61,65],{"name":62,"role":43,"phone":63,"phoneExt":35,"email":64},"Ben Briggs, QA officer","802-656-2021","ben.briggs@med.uvm.edu",{"name":66,"role":67,"phone":35,"phoneExt":35,"email":35},"Randall F Holcombe, MD, MBA","PRINCIPAL_INVESTIGATOR",{"type":67,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"Randall F Holcombe","Director-Faculty","100598506","nutritional-prehabilitation-to-improve-cancer-outcomes-n-pico-100598506",false,"NCT07072377","Nutritional Prehabilitation to Improve Cancer Outcomes (N-PICO)","N-PICO","Inclusion Criteria:\n\n* Diagnosis of invasive cancer with plans to initiate chemo-, immune-, targeted-, or hormonal therapy for treatment of their malignancy, or within one month of starting treatment.\n* Age ≥ 18 years of age.\n* Patients must be able to read, write, and speak English as study material and virtual nutrition consultation calls are only available in English.\n* Patients receiving treatment at a participating ambulatory medical oncology site.\n* Willingness to have a remote nutritional consultation and complete questionnaires\u002Fsurveys.\n* Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.\n\nExclusion Criteria:\n\n* Diagnosis of acute leukemia (these patients generally receive predominantly inpatient care).\n* Diagnosis of head \\& neck cancer, esophageal cancer, gastric cancer, patients presenting with recognized cachexia or severe malnutrition, or patients with PEG tubes for enteral feeding.\n\nRationale: These patients would normally be referred for dietary consultation and may need ongoing clinical intervention from an on-site dietitian beyond the period of the proposed study","ALL","18 Years",{"count":81,"type":82},240,"ESTIMATED","INTERVENTIONAL",[85],"NA","Brief Summary\n\nThe goal of this clinical trial is to evaluate the acceptability and adherence of low- and high-intensity remote nutritional interventions for cancer patients in rural and urban areas, specifically focusing on those with invasive cancer who are about to start treatment. The main question\\[s\\] it aims to answer are:\n\nCan low- and high-intensity remote nutritional interventions improve adherence to cancer treatment and quality of life? What is the impact of nutritional support on treatment delays, unplanned healthcare utilization, and dietary modifications? Researchers will compare the low-intensity arm (initial nutritional consultation plus written materials) to the high-intensity arm (1-hour consultation, monthly follow-ups, and written materials) to see if higher intensity interventions lead to better outcomes in terms of adherence, quality of life, and healthcare utilization.\n\nParticipants will:\n\nReceive either a low- or high-intensity nutritional consultation. Complete surveys assessing quality of life, dietary habits, treatment delays, and unplanned healthcare use.\n\nBe asked to participate in monthly follow-up consultations (for the high-intensity group) to track progress and provide additional support.",[88,89,90,91,92,93],"Malnutrition","Cancer-related Malnutrition","Quality of Life (QOL)","Nutritional Support","Nutritional Interventions","Rural Health",[95,96,97,98,99,100,101,102],"Cancer Nutrition Intervention","Malnutrition in Cancer Patients","Nutritional Support for Cancer","Prehabilitation Program for Cancer","Rural Cancer Nutrition","Quality of Life and Cancer Nutrition","Remote Nutritional Consultations","Cancer Treatment Outcomes and Nutrition","2026-02-02",{"date":105,"type":106},"2026-02-05","ACTUAL",{"date":108,"type":106},"2025-09-10",{"date":110,"type":82},"2028-09",{"name":5,"class":6},1]