Remote nutritional prehabilitation for people with invasive cancer starting treatment
Nutritional Prehabilitation to Improve Cancer Outcomes (N-PICO)
This study will test whether low- versus high-intensity remote nutrition support helps adults with invasive cancer who are starting systemic treatment stick with their treatment and feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Vermont Medical Center Academic / other |
| Locations | 1 site (Burlington, Vermont) |
| Trial ID | NCT07072377 on ClinicalTrials.gov |
What this trial studies
This randomized two-arm pilot compares a low-intensity remote nutrition consultation plus written materials to a high-intensity program with a 1-hour initial consultation and monthly follow-ups delivered remotely. The trial enrolls adults with invasive cancer who are initiating systemic therapy at the University of Vermont Cancer Center and affiliated sites in Vermont and northern New York, targeting both rural and urban patients. The primary aim is feasibility measured by adherence to scheduled consultations and dietary goals, with secondary measures of acceptability by survey and exploratory outcomes including quality of life, treatment delays, unplanned healthcare use, and dietary changes. Interventions are remote to reduce travel burden and improve access, especially for patients in rural areas.
Who should consider this trial
Good fit: Adults (≥18) with a diagnosis of invasive cancer who are about to start or are within one month of starting chemo-, immune-, targeted-, or hormonal therapy, who receive care at a participating ambulatory oncology site and can complete English-language remote consultations and surveys.
Not a fit: Patients with acute leukemia, head and neck/esophageal/gastric cancers, those with recognized cachexia or severe malnutrition, non-English speakers, or those who cannot participate in remote visits are unlikely to be eligible or to benefit from these interventions.
Why it matters
Potential benefit: If successful, the interventions could improve patients' ability to complete planned cancer treatment, reduce treatment delays and unplanned healthcare visits, and improve quality of life during therapy.
How similar studies have performed: In-person nutrition support has shown benefits for some cancer patients, but remote prehabilitation and direct comparisons of low- versus high-intensity remote nutrition programs are relatively novel and less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. * Age ≥ 18 years of age. * Patients must be able to read, write, and speak English as study material and virtual nutrition consultation calls are only available in English. * Patients receiving treatment at a participating ambulatory medical oncology site. * Willingness to have a remote nutritional consultation and complete questionnaires/surveys. * 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. Exclusion Criteria: * Diagnosis of acute leukemia (these patients generally receive predominantly inpatient care). * 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. Rationale: 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
Where this trial is running
Burlington, Vermont
- University of Vermont Medical Center — Burlington, Vermont, United States (Recruiting)
Study contacts
- Study coordinator: Randall F Holcombe, MD
- Email: Randall.holcombe@med.uvm.edu
- Phone: 1 (802) 656-2021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.