The primary objective of this study is to determine the effect of a 6-month pilot randomized controlled trial of medically tailored grocery delivery plus nutrition counseling vs. medically tailored grocery delivery alone vs. standard of care (with delayed grocery delivery alone) among 100 individuals with any stage and type cancer who reside in Maine on change in diet quality from baseline to 6-months. The secondary objective is to assess the benefits of the intervention on change from baseline to 6-months on self-reported healthcare utilization (e.g., hospitalizations, emergency room visits), malnutrition, cancer-treatment related symptoms, food insecurity, quality of life, and financial toxicity. We will also evaluate feasibility and acceptability of the intervention in the target population.
The purpose of this study is to assess the effect of a 6-month intervention of medically tailored groceries plus nutrition counseling vs. medically tailored groceries alone vs. standard of care on diet and health outcomes among 100 cancer survivors who reside in Maine. This project will be conducted in partnership with the Christine B. Foundation which has been delivering medically tailored groceries to cancer survivors in Maine since 2020, but has not yet evaluated the impact of this nutrition program on important health outcomes in people living with cancer. The eligibility criteria matched the population of cancer survivors currently served by the Christine B. Foundation as we are testing the effect of their services on health-related outcomes in their target population. Given medically tailored meals and groceries have conferred health benefits in other patient populations, but there is limited research among cancer survivors, this highly innovative study and could provide evidence on the potential benefits of this type of nutrition intervention specifically for cancer survivors.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
100
Weekly delivery of medically tailored groceries plus 8 remote nutritional counselling sessions.
Weekly delivery of medically tailored groceries.
Option to pick up fresh produce weekly from participating clinics. Medically tailored grocery delivery will be available for 6 months beginning at the end of the study.
Yale School of Public Health
New Haven, Connecticut, United States
RECRUITINGDiet Quality
Recent diet will be assessed via food frequency questionnaire (FFQ). Diet quality will be calculated using the HEI-2020; range of 0 - 100, higher score indicating better diet quality.
Time frame: Change from baseline to 6 months
Food Insecurity
United Stated Department of Agriculture 6-item questionnaire; range of 0-6, higher score indicating lower food security.
Time frame: Change from baseline to 6 months
Health Related Quality of Life
12-item Short Form Survey (SF-12) will be used to generate the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Using norm based scores, above 50 indicate a better-than-average health-related quality of life.
Time frame: Change from baseline to 6 months
Cancer-Treatment Related Symptoms
Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Count of number of symptoms.
Time frame: Change from baseline to 6 months
Healthcare Utilization
Self-reported visits and admissions to emergency rooms, urgent care clinics, and in-patient facilities.
Time frame: Number from baseline to 6 months
Malnutrition
Patient-Generated Subjective Global Assessment (PG-SGA); range of 0-33, higher score indicating greater likelihood of malnutrition.
Time frame: Change from baseline to 6 months
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