Actively Recruiting
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
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the feasibility and impact of remote nutritional support for patients with invasive cancer who are starting treatment. This study compares low- and high-intensity interventions delivered remotely to patients in both rural and urban areas. The main goals are to see if these nutritional programs improve adherence to cancer treatment, quality of life, and reduce treatment delays and unplanned healthcare use. The study will provide insights to help design larger trials focused on underserved cancer patients. Participants are randomly assigned to either a low-intensity or high-intensity nutritional support group. The low-intensity group receives a one-time remote nutritional consultation plus educational materials about protein and calorie intake. The high-intensity group receives an initial 1-hour consultation, monthly follow-up consultations for six weeks, and the same educational materials. Interventions are delivered remotely to improve access and reduce travel burdens. During the study, participants complete surveys on quality of life, dietary habits, treatment adherence, and healthcare use. Data such as treatment delays and emergency visits are collected from medical records. Researchers measure adherence to the nutritional programs and participant satisfaction over six months. The trial includes ongoing monitoring through follow-ups and questionnaires to assess clinical impact and acceptability.
CONDITIONS
Brief Title
Nutritional Prehabilitation to Improve Cancer Outcomes (N-PICO)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of invasive cancer with plans to start chemotherapy, immunotherapy, targeted therapy, or hormonal therapy within one month or currently receiving 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 remote nutritional consultations and complete surveys
- Signed informed consent according to institutional and federal guidelines
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
- Use of PEG tubes for enteral feeding
- Need for ongoing clinical intervention by an on-site dietitian beyond the study period due to condition severity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (remote or in-person)
Duration - 6 weeks
Participants receive either a low-intensity or high-intensity remote nutritional intervention to support them during cancer treatment.
1 initial consultation and up to 3 monthly follow-up consultations for high-intensity arm; 1 consultation for low-intensity arm
Duration - 6 months
Participants complete surveys and assessments to evaluate adherence, acceptability, quality of life, dietary changes, and healthcare utilization over 6 months.
Periodic remote surveys and assessments
Trial Site Locations
Total: 1 location
1
University of Vermont Medical Center
Burlington, Vermont, United States, 05401
Actively Recruiting
Research Team
R
Randall F Holcombe, MD
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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