Nutritional Prehabilitation to Improve Cancer Outcomes (N-PICO)

This randomized, two-arm pilot study evaluates the feasibility, acceptability, and clinical impact of low- and high-intensity remote nutritional interventions for patients with invasive cancer who are initiating treatment. The study targets both rural and urban populations and will enroll participants at the University of Vermont Cancer Center and affiliated sites across Vermont and northern New York.

Participants are randomly assigned to one of two intervention arms:

Low-Intensity Arm: Participants receive a one-time remote nutritional consultation and a packet of standardized educational materials, designed to provide foundational guidance on protein and calorie intake during cancer treatment.

High-Intensity Arm: Participants receive an initial 1-hour consultation followed by monthly follow-up consultations (total of three across six weeks), in addition to the same educational materials. The goal is to offer personalized and sustained support throughout the course of treatment.

The interventions are delivered remotely to reduce logistical burden and improve accessibility, particularly for patients in rural settings.

The study's primary objective is to evaluate the feasibility of implementing these remote interventions, measured by participant adherence to scheduled consultations and dietary goals. Secondary objectives include assessments of acceptability (via structured participant surveys) and exploratory evaluation of changes in quality of life, dietary behaviors, treatment adherence, and unplanned healthcare utilization.

Validated tools used include the FACT-G (Functional Assessment of Cancer Therapy-General), a brief satisfaction survey, and the NHANES Dietary Screener Questionnaire. Clinical and utilization data (e.g., treatment delays, emergency department visits, unplanned hospitalizations) will be abstracted from the medical record.

This pilot study is intended to inform the design of a future larger trial by generating preliminary data on the practicality and clinical utility of nutritional prehabilitation strategies, especially for underserved cancer patients in rural areas.

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