Nutritional Prehabilitation to Improve Cancer Outcomes (N-PICO)

NCT07072377 | Recruiting DMC

• 1 other identifier: UVMCC2501
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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

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

Outcome Measures

Primary Outcomes (2)

• Adherence to Assigned Nutritional Intervention (Low- vs. High-Intensity)

  Adherence will be assessed over the 6-week intervention period using two metrics: 1. Proportion of scheduled dietary counseling contacts completed (≥70% completion threshold), and 2. 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 (%)

  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

  6 months

Secondary Outcomes (4)

• Change in Quality of Life Measured by the PROMIS Global Health Scale

  6 months

• Patient-Reported Dietary Behavior Change

  Unit of Measure: Proportion of participants reporting positive dietary change (%)

• Frequency of Treatment Delays or Modifications During Chemoradiation

  6 months

• Unplanned Healthcare Utilization (ER Visits and Unplanned Hospitalizations)

  6 months

Study Arms (6)

Rural, Remote, Low-Intensity

EXPERIMENTAL

Rural, Remote, Low-Intensity

Behavioral: Intensity of Nutritional Intervention

Rural, Remote, High-Intensity

EXPERIMENTAL

Rural, Remote, High-Intensity

Behavioral: Intensity of Nutritional Intervention

Urban, Remote, Low-Intensity

EXPERIMENTAL

Urban, Remote, Low-Intensity

Behavioral: Intensity of Nutritional Intervention; Behavioral: Remote or In-Person

Urban, Remote, High-Intensity

EXPERIMENTAL

Urban, Remote, High-Intensity

Behavioral: Intensity of Nutritional Intervention; Behavioral: Remote or In-Person

Urban, In-Person, Low-Intensity

EXPERIMENTAL

Urban, In-Person, Low-Intensity

Behavioral: Intensity of Nutritional Intervention; Behavioral: Remote or In-Person

Urban, In-Person, High-Intensity

EXPERIMENTAL

Urban, In-Person, High-Intensity

Behavioral: Intensity of Nutritional Intervention; Behavioral: Remote or In-Person

Interventions

Intensity of Nutritional Intervention BEHAVIORAL

Participants will either receive High or Low intensity nutritional support.

Rural, Remote, High-Intensity; Rural, Remote, Low-Intensity; Urban, In-Person, High-Intensity; Urban, In-Person, Low-Intensity; Urban, Remote, High-Intensity; Urban, Remote, Low-Intensity

Remote or In-Person BEHAVIORAL

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

Urban, In-Person, High-Intensity; Urban, In-Person, Low-Intensity; Urban, Remote, High-Intensity; Urban, Remote, Low-Intensity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vermont Medical Center: lead

Study Sites (1)

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

RECRUITING

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Central Study Contacts

Randall F Holcombe, MD

CONTACT

1 (802) 656-2021; Randall.holcombe@med.uvm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director-Faculty

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: July 18, 2025
• Study Start: September 10, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)