Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07072377

Nutritional Prehabilitation to Improve Cancer Outcomes (N-PICO)

Led by University of Vermont Medical Center · Updated on 2026-02-05

240

Participants Needed

1

Research Sites

155 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Nutritional Prehabilitation to Improve Cancer Outcomes (N-PICO)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of invasive cancer with plans to start chemo-, immune-, targeted-, or hormonal therapy, or within one month of starting treatment
  • Age 18 years or older
  • Ability to read, write, and speak English
  • Receiving treatment at a participating ambulatory medical oncology site
  • Willingness to have a remote nutritional consultation and complete surveys
  • Signed informed consent according to institutional and federal guidelines
Not Eligible

You will not qualify if you...

  • Diagnosis of acute leukemia
  • Diagnosis of head and neck cancer, esophageal cancer, or gastric cancer
  • Presence of recognized cachexia or severe malnutrition
  • Having a PEG tube for enteral feeding
  • Need for ongoing clinical intervention from an on-site dietitian beyond the study period

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Vermont Medical Center

Burlington, Vermont, United States, 05401

Actively Recruiting

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Research Team

R

Randall F Holcombe, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

6

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Nutritional Prehabilitation to Improve Cancer Outcomes (N-PICO) | DecenTrialz