Malnutrition Clinical Trials

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Nutritional Prehabilitation to Improve Cancer Outcomes (N-PICO)

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Vermont
University of Vermont Medical Center
RECRUITING
Burlington
Contact Information
Primary
Randall F Holcombe, MD
Randall.holcombe@med.uvm.edu
1 (802) 656-2021
Time Frame
Start Date: 2025-09-10
Estimated Completion Date: 2028-09
Participants
Target number of participants: 240
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: University of Vermont Medical Center

This content was sourced from clinicaltrials.gov