NCT07072377 Nutritional Prehabilitation to Improve Cancer Outcomes (N-PICO)
| NCT ID | NCT07072377 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Vermont Medical Center |
| Condition | Malnutrition |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2025-09-10 |
| Primary Completion | 2028-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 240 participants in total. It began in 2025-09-10 with a primary completion date of 2028-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07072377 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Malnutrition. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07072377 currently recruiting?
Yes, NCT07072377 is actively recruiting participants. Contact the research team at Randall.holcombe@med.uvm.edu for enrollment information.
Where is the NCT07072377 trial being conducted?
This trial is being conducted at Burlington, United States.
Who is sponsoring the NCT07072377 clinical trial?
NCT07072377 is sponsored by University of Vermont Medical Center. The trial plans to enroll 240 participants.