Nutritional Prehabilitation to Improve Cancer Outcomes (N-PICO)

Part of paid clinical trials in Burlington, Vermont.

Sponsor
University of Vermont Medical Center
Study ID
NCT07072377
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intensity of Nutritional Intervention — BEHAVIORAL
    Participants will either receive High or Low intensity nutritional support.
  • Remote or In-Person — BEHAVIORAL
    Patients will either receive their support in-person or remotely.

Study Details

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.

Key Dates

Start date
Sep 10, 2025
Status verified
Feb 2026
Primary completion
May 31, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Rural, Remote, Low-Intensity
    Rural, Remote, Low-Intensity
  • Experimental: Rural, Remote, High-Intensity
    Rural, Remote, High-Intensity
  • Experimental: Urban, Remote, Low-Intensity
    Urban, Remote, Low-Intensity
  • Experimental: Urban, Remote, High-Intensity
    Urban, Remote, High-Intensity
  • Experimental: Urban, In-Person, Low-Intensity
    Urban, In-Person, Low-Intensity
  • Experimental: Urban, In-Person, High-Intensity
    Urban, In-Person, High-Intensity

Primary Outcome Measure

Adherence to Assigned Nutritional Intervention (Low- vs. High-Intensity) [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Vermont Medical CenterBurlingtonVermont05401
Ben Briggs, QA officer
[email protected]
802-656-2021
Randall F Holcombe, MD, MBA (PRINCIPAL_INVESTIGATOR)

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University of Vermont Medical Center· Burlington, VT

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