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.
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.
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.
Parallel
Intensity of Nutritional Intervention
BehavioralParticipants will either receive High or Low intensity nutritional support.
Remote or In-Person
BehavioralPatients will either receive their support in-person or remotely.
6
Treatment groupsSee each treatment group below.
Adherence to Assigned Nutritional Intervention (Low- vs. High-Intensity)
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
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
Change in Quality of Life Measured by the PROMIS Global Health Scale
Participant quality of life will be measured using the PROMIS Global Health v1.2 questionnaire at baseline and after the 6-week intervention. This tool provides T-scores for physical and mental health domains. Changes in mean T-scores will be compared between intervention arms. Unit of Measure: Mean change in PROMIS T-scores (range: 0-100; higher scores = better health)
Patient-Reported Dietary Behavior Change
Participants will report dietary behavior changes related to protein and calorie intake via a structured questionnaire administered at 6 weeks. Survey results will include frequency of changes (e.g., increased protein intake) and perceived ease of implementation.
Frequency of Treatment Delays or Modifications During Chemoradiation
Treatment delays or dose modifications (e.g., chemotherapy hold, radiation rescheduling) will be extracted from the EMR and documented during the 6-week treatment window. Unit of Measure: Number of delays or modifications per participant
Unplanned Healthcare Utilization (ER Visits and Unplanned Hospitalizations)
The number of unplanned emergency room visits and unplanned hospital admissions during the intervention period will be recorded and compared between arms. Unit of Measure: Count of ER visits or unplanned hospitalizations per participant
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