Nutritional Prehabilitation to Improve Cancer Outcomes (N-PICO)

NCT ID: NCT07072377

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2028-09-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Rural, Remote, Low-Intensity

Rural, Remote, Low-Intensity

Group Type: EXPERIMENTAL

Intensity of Nutritional Intervention

Intervention Type: BEHAVIORAL

Participants will either receive High or Low intensity nutritional support.

Rural, Remote, High-Intensity

Rural, Remote, High-Intensity

Group Type: EXPERIMENTAL

Intensity of Nutritional Intervention

Intervention Type: BEHAVIORAL

Participants will either receive High or Low intensity nutritional support.

Urban, Remote, Low-Intensity

Urban, Remote, Low-Intensity

Group Type: EXPERIMENTAL

Intensity of Nutritional Intervention

Intervention Type: BEHAVIORAL

Participants will either receive High or Low intensity nutritional support.

Remote or In-Person

Intervention Type: BEHAVIORAL

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

Urban, Remote, High-Intensity

Urban, Remote, High-Intensity

Group Type: EXPERIMENTAL

Intensity of Nutritional Intervention

Intervention Type: BEHAVIORAL

Participants will either receive High or Low intensity nutritional support.

Remote or In-Person

Intervention Type: BEHAVIORAL

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

Urban, In-Person, Low-Intensity

Urban, In-Person, Low-Intensity

Group Type: EXPERIMENTAL

Intensity of Nutritional Intervention

Intervention Type: BEHAVIORAL

Participants will either receive High or Low intensity nutritional support.

Remote or In-Person

Intervention Type: BEHAVIORAL

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

Urban, In-Person, High-Intensity

Urban, In-Person, High-Intensity

Group Type: EXPERIMENTAL

Intensity of Nutritional Intervention

Intervention Type: BEHAVIORAL

Participants will either receive High or Low intensity nutritional support.

Remote or In-Person

Intervention Type: BEHAVIORAL

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

Interventions

Intensity of Nutritional Intervention

Participants will either receive High or Low intensity nutritional support.

Intervention Type: BEHAVIORAL

Remote or In-Person

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Vermont Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Randall F Holcombe

Director-Faculty

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Vermont Medical Center

Burlington, Vermont, United States

Countries

United States

Central Contacts

Randall F Holcombe, MD

Role: CONTACT

Randall.holcombe@med.uvm.edu

1 (802) 656-2021

Facility Contacts

Ben Briggs, QA officer

Role: primary

ben.briggs@med.uvm.edu

802-656-2021

Other Identifiers

UVMCC2501

Identifier Type: -

Identifier Source: org_study_id