RecruitingNot Applicable

Nutritional Prehabilitation to Improve Cancer Outcomes (N-PICO)

United States240 participantsStarted 2025-09-10

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

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

Timeframe: 6 months

Acceptability of Nutritional Intervention Based on Participant Survey

Timeframe: 6 months

Trial details

NCT IDNCT07072377

SponsorUniversity of Vermont Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-05

Contact for this trial

Randall F Holcombe, MD

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