Recruiting

Nutritional Interventions

Sponsor:

University of Vermont Medical Center

Code:

NCT07072377

Conditions

Malnutrition

Cancer-related Malnutrition

Quality of Life (QOL)

Nutritional Support

Nutritional Interventions

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intensity of Nutritional Intervention

Remote or In-Person

Study Details

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

Study ID

NCT07072377

Start date

Sep 10, 2025

Status verified date

Feb, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Rural, Remote, Low-Intensity

Rural, Remote, Low-Intensity

experimental: Rural, Remote, High-Intensity

Rural, Remote, High-Intensity

experimental: Urban, Remote, Low-Intensity

Urban, Remote, Low-Intensity

experimental: Urban, Remote, High-Intensity

Urban, Remote, High-Intensity

experimental: Urban, In-Person, Low-Intensity

Urban, In-Person, Low-Intensity

experimental: Urban, In-Person, High-Intensity

Urban, In-Person, High-Intensity

Interventions

Intensity of Nutritional Intervention

Participants will either receive High or Low intensity nutritional support.

Remote or In-Person

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

Primary outcome measure

  • Adherence to Assigned Nutritional Intervention (Low- vs. High-Intensity) [ Time Frame: 6 months ]
  • Acceptability of Nutritional Intervention Based on Participant Survey [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Randall F Holcombe, MD

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

Locations

University of Vermont Medical Center

Recruiting

Burlington, Vermont, United States, 05401

Contacts

Ben Briggs, QA officer

802-656-2021ben.briggs@med.uvm.edu

Principal Investigator:

Randall F Holcombe, MD, MBA

More Information

Sponsor

University of Vermont Medical Center

Last update posted

Feb 5, 2026

Last verified

Feb, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Vermont Medical Center on 2026-02-05.