Remote nutritional prehabilitation for people with invasive cancer starting treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized two-arm pilot compares a low-intensity remote nutrition consultation plus written materials to a high-intensity program with a 1-hour initial consultation and monthly follow-ups delivered remotely. The trial enrolls adults with invasive cancer who are initiating systemic therapy at the University of Vermont Cancer Center and affiliated sites in Vermont and northern New York, targeting both rural and urban patients. The primary aim is feasibility measured by adherence to scheduled consultations and dietary goals, with secondary measures of acceptability by survey and exploratory outcomes including quality of life, treatment delays, unplanned healthcare use, and dietary changes. Interventions are remote to reduce travel burden and improve access, especially for patients in rural areas.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Vermont Medical Center
  Burlington, Vermont, United States Recruiting

Study contacts

• Study coordinator: Randall F Holcombe, MD
• Email: Randall.holcombe@med.uvm.edu
• Phone: 1 (802) 656-2021

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.