Nourishing Hope: The Impact of Nutrition in Cancer Treatment and Recovery in Maine
NCT07076004 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2025-09-02
Summary
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.
Conditions
Interventions
- BEHAVIORAL
-
Medically Tailored Grocery Plus Nutrition Counseling Group
Weekly delivery of medically tailored groceries plus 8 remote nutritional counselling sessions.
- BEHAVIORAL
-
Experimental: Medically Tailored Grocery Group
Weekly delivery of medically tailored groceries.
- BEHAVIORAL
-
Standard of Care Group with Delayed Medically Tailored Grocery Delivery
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.
Sponsors & Collaborators
-
Christine B. Foundation
collaborator UNKNOWN -
Yale University
lead OTHER
Principal Investigators
-
Leah M Ferrucci, PhD · Yale University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- SINGLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-07-30
- Primary Completion
- 2026-09-30
- Completion
- 2026-09-30
Countries
- United States
Study Locations
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