Nutritional Prehabilitation to Improve Cancer Outcomes (N-PICO)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Adherence to Assigned Nutritional Intervention (Low- vs. High-Intensity)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Rural, Remote, Low-Intensity
Rural, Remote, Low-Intensity
干预措施: Intensity of Nutritional Intervention (Behavioral)
Rural, Remote, High-Intensity
Rural, Remote, High-Intensity
干预措施: Intensity of Nutritional Intervention (Behavioral)
Urban, Remote, High-Intensity
Urban, Remote, High-Intensity
干预措施: Intensity of Nutritional Intervention (Behavioral)
Urban, Remote, Low-Intensity
Urban, Remote, Low-Intensity
干预措施: Intensity of Nutritional Intervention (Behavioral)
Urban, Remote, Low-Intensity
Urban, Remote, Low-Intensity
干预措施: Remote or In-Person (Behavioral)
Urban, Remote, High-Intensity
Urban, Remote, High-Intensity
干预措施: Remote or In-Person (Behavioral)
Urban, In-Person, Low-Intensity
Urban, In-Person, Low-Intensity
干预措施: Intensity of Nutritional Intervention (Behavioral)
Urban, In-Person, Low-Intensity
Urban, In-Person, Low-Intensity
干预措施: Remote or In-Person (Behavioral)
Urban, In-Person, High-Intensity
Urban, In-Person, High-Intensity
干预措施: Intensity of Nutritional Intervention (Behavioral)
Urban, In-Person, High-Intensity
Urban, In-Person, High-Intensity
干预措施: Remote or In-Person (Behavioral)
结局指标
主要结局
Adherence to Assigned Nutritional Intervention (Low- vs. High-Intensity)
时间窗: 6 months
Adherence will be assessed over the 6-week intervention period using two metrics: 1. Proportion of scheduled dietary counseling contacts completed (≥70% completion threshold), and 2. Participant self-report of meeting ≥70% of individualized nutrition goals, recorded weekly. Adherence will be summarized as the percentage of participants in each arm who meet both criteria. Unit of Measure: Percentage of participants meeting adherence threshold (%)
Acceptability of Nutritional Intervention Based on Participant Survey
时间窗: 6 months
Acceptability will be measured at the end of the 6-week intervention using a structured participant survey developed for the study. This survey includes Likert-scale questions (e.g., ease of use, satisfaction, perceived helpfulness) and open-ended feedback. Responses will be analyzed to compare acceptability between low- and high-intensity intervention arms. Unit of Measure: Mean score on acceptability survey
次要结局
- Change in Quality of Life Measured by the PROMIS Global Health Scale(6 months)
- Patient-Reported Dietary Behavior Change(Unit of Measure: Proportion of participants reporting positive dietary change (%))
- Frequency of Treatment Delays or Modifications During Chemoradiation(6 months)
- Unplanned Healthcare Utilization (ER Visits and Unplanned Hospitalizations)(6 months)
研究者
Randall F Holcombe
Director-Faculty
University of Vermont Medical Center