MalnutritionN-PICONCT07072377
Nutritional Prehabilitation to Improve Cancer Outcomes (N-PICO)
A study testing Intensity of Nutritional Intervention and Remote or In-Person in people with Malnutrition and Cancer-related Malnutrition, run by University of Vermont Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition, Cancer-related Malnutrition, Quality of Life (QOL)
- What is being tested?
- Intensity of Nutritional Intervention and Remote or In-Person
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2025to Sep 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Diagnosis of acute leukemia (these patients generally receive predominantly inpatient care).
- Diagnosis of head \& neck cancer, esophageal cancer, gastric cancer, patients presenting with recognized cachexia or severe malnutrition, or patients with PEG tubes for enteral feeding.
- Rationale: These patients would normally be referred for dietary consultation and may need ongoing clinical intervention from an on-site dietitian beyond the period of the proposed study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Vermont Medical Center
Burlington, Vermont, 05401
Ben Briggs, QA officer, 802-656-2021, ben.briggs@med.uvm.edu
Randall F Holcombe, MD, MBA
About this study
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:
Read more
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.
Read the detailed description
This randomized, two-arm pilot study evaluates the feasibility, acceptability, and clinical impact of low- and high-intensity remote nutritional interventions for patients with invasive cancer who are initiating treatment. The study targets both rural and urban populations and will enroll participants at the University of Vermont Cancer Center and affiliated sites across Vermont and northern New York.
Participants are randomly assigned to one of two intervention arms:
Low-Intensity Arm: Participants receive a one-time remote nutritional consultation and a packet of standardized educational materials, designed to provide foundational guidance on protein and calorie intake during cancer treatment.
High-Intensity Arm: Participants receive an initial 1-hour consultation followed by monthly follow-up consultations (total of three across six weeks), in addition to the same educational materials. The goal is to offer personalized and sustained support throughout the course of treatment.
The interventions are delivered remotely to reduce logistical burden and improve accessibility, particularly for patients in rural settings.
The study's primary objective is to evaluate the feasibility of implementing these remote interventions, measured by participant adherence to scheduled consultations and dietary goals. Secondary objectives include assessments of acceptability (via structured participant surveys) and exploratory evaluation of changes in quality of life, dietary behaviors, treatment adherence, and unplanned healthcare utilization.
Validated tools used include the FACT-G (Functional Assessment of Cancer Therapy-General), a brief satisfaction survey, and the NHANES Dietary Screener Questionnaire. Clinical and utilization data (e.g., treatment delays, emergency department visits, unplanned hospitalizations) will be abstracted from the medical record.
This pilot study is intended to inform the design of a future larger trial by generating preliminary data on the practicality and clinical utility of nutritional prehabilitation strategies, especially for underserved cancer patients in rural areas.
- Conditions
- Malnutrition, Cancer-related Malnutrition, Quality of Life (QOL), Nutritional Support, Nutritional Interventions, Rural Health
- Being tested
- Intensity of Nutritional Intervention, Remote or In-Person
- Keywords
- Cancer Nutrition Intervention, Malnutrition in Cancer Patients, Nutritional Support for Cancer, Prehabilitation Program for Cancer, Rural Cancer Nutrition, Quality of Life and Cancer Nutrition, Remote Nutritional Consultations, Cancer Treatment Outcomes and Nutrition
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensity of Nutritional InterventionBehavioural
Participants will either receive High or Low intensity nutritional support.
Remote or In-PersonBehavioural
Patients will either receive their support in-person or remotely.
| Study group | Role | What they receive |
|---|---|---|
| Rural, Remote, Low-Intensity | Experimental | Rural, Remote, Low-Intensity Receives: Behavioral: Intensity of Nutritional Intervention |
| Rural, Remote, High-Intensity | Experimental | Rural, Remote, High-Intensity Receives: Behavioral: Intensity of Nutritional Intervention |
| Urban, Remote, Low-Intensity | Experimental | Urban, Remote, Low-Intensity Receives: Behavioral: Intensity of Nutritional Intervention; Behavioral: Remote or In-Person |
| Urban, Remote, High-Intensity | Experimental | Urban, Remote, High-Intensity Receives: Behavioral: Intensity of Nutritional Intervention; Behavioral: Remote or In-Person |
| Urban, In-Person, Low-Intensity | Experimental | Urban, In-Person, Low-Intensity Receives: Behavioral: Intensity of Nutritional Intervention; Behavioral: Remote or In-Person |
| Urban, In-Person, High-Intensity | Experimental | Urban, In-Person, High-Intensity Receives: Behavioral: Intensity of Nutritional Intervention; Behavioral: Remote or In-Person |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to Assigned Nutritional Intervention (Low- vs. High-Intensity)
Adherence will be assessed over the 6-week intervention period using two metrics:
- Proportion of scheduled dietary counseling contacts completed (≥70% completion threshold), and
- Participant self-report of meeting ≥70% of individualized nutrition goals, recorded weekly.
Adherence will be summarized as the percentage of participants in each arm who meet both criteria.
Unit of Measure: Percentage of participants meeting adherence threshold (%)
Measured: 6 months
Acceptability of Nutritional Intervention Based on Participant Survey
Acceptability will be measured at the end of the 6-week intervention using a structured participant survey developed for the study. This survey includes Likert-scale questions (e.g., ease of use, satisfaction, perceived helpfulness) and open-ended feedback. Responses will be analyzed to compare acceptability between low- and high-intensity intervention arms.
Unit of Measure: Mean score on acceptability survey
Measured: 6 months
Secondary outcomes (4)
Change in Quality of Life Measured by the PROMIS Global Health Scale
Participant quality of life will be measured using the PROMIS Global Health v1.2 questionnaire at baseline and after the 6-week intervention. This tool provides T-scores for physical and mental health domains. Changes in mean T-scores will be compared between intervention arms.
Unit of Measure: Mean change in PROMIS T-scores (range: 0-100; higher scores = better health)
Measured: 6 months
Patient-Reported Dietary Behavior Change
Participants will report dietary behavior changes related to protein and calorie intake via a structured questionnaire administered at 6 weeks. Survey results will include frequency of changes (e.g., increased protein intake) and perceived ease of implementation.
Measured: Unit of Measure: Proportion of participants reporting positive dietary change (%)
Frequency of Treatment Delays or Modifications During Chemoradiation
Treatment delays or dose modifications (e.g., chemotherapy hold, radiation rescheduling) will be extracted from the EMR and documented during the 6-week treatment window.
Unit of Measure: Number of delays or modifications per participant
Measured: 6 months
Unplanned Healthcare Utilization (ER Visits and Unplanned Hospitalizations)
The number of unplanned emergency room visits and unplanned hospital admissions during the intervention period will be recorded and compared between arms.
Unit of Measure: Count of ER visits or unplanned hospitalizations per participant
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start10 Sep 2025
- Primary completionMay 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vermont Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randall F Holcombe, University of Vermont Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07072377
- Sponsor's protocol ID
- UVMCC2501
- Acronym
- N-PICO
- Status last verified
- Feb 2026
- First submitted
- 22 May 2025
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymized patient related data will be incorporated into publications and will be made available to other investigators at reasonable request.