Nutritional Prehabilitation to Improve Cancer Outcomes (N-PICO)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Vermont Medical Center

About this trial

Brief Summary

The 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:

Can 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.

Participants will:

Receive either a low- or high-intensity nutritional consultation. Complete surveys assessing quality of life, dietary habits, treatment delays, and unplanned healthcare use.

Be asked to participate in monthly follow-up consultations (for the high-intensity group) to track progress and provide additional support.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Intensity of Nutritional Intervention
  • Remote or In-Person

Treatment groups

240 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.