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Nutritional Prehabilitation to Improve Cancer Outcomes (N-PICO)

NCT07072377 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-02-05

No results posted yet for this study

Summary

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

  • Malnutrition
  • Cancer-related Malnutrition
  • Quality of Life (QOL)
  • Nutritional Support
  • Nutritional Interventions
  • Rural Health

Interventions

BEHAVIORAL

Intensity of Nutritional Intervention

Participants will either receive High or Low intensity nutritional support.

BEHAVIORAL

Remote or In-Person

Patients will either receive their support in-person or remotely.

Sponsors & Collaborators

  • University of Vermont Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-10
Primary Completion
2028-05-31
Completion
2028-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07072377 on ClinicalTrials.gov