Nourishing Hope: The Impact of Nutrition in Cancer Treatment and Recovery in Maine

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT07076004
Status
Recruiting
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Conditions

  • Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Medically Tailored Grocery Plus Nutrition Counseling Group — BEHAVIORAL
    Weekly delivery of medically tailored groceries plus 8 remote nutritional counselling sessions.
  • Experimental: Medically Tailored Grocery Group — BEHAVIORAL
    Weekly delivery of medically tailored groceries.
  • Standard of Care Group with Delayed Medically Tailored Grocery Delivery — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Jul 30, 2025
Status verified
Aug 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Standard of Care Group with Delayed Medically Tailored Grocery Delivery
    Option to pick-up fresh produce (fruits and vegetables) once per week from clinic locations served by the Christine B. Foundation at any time during the six-month study. At the end of the six-month study, participants in this arm will receive a delivery of free medically tailored groceries each week for six-month. They can select preferred types of proteins, grains, fruits, and vegetables. The size of the grocery delivery is adjusted for the number of people living in the household.
  • Experimental: Medically Tailored Grocery Group
    A delivery of free medically tailored groceries each week for the six-month study. They can select preferred types of proteins, grains, fruits, and vegetables. The size of the grocery delivery is adjusted for the number of people living in the household. They will also have the option to pick-up fresh produce (fruits and vegetables) once per week from clinic locations served by the Christine B. Foundation during the study.
  • Experimental: Medically Tailored Grocery Plus Nutrition Counseling Group
    Delivery of free medically tailored groceries each week for the 6-month study. They can select preferred types of proteins, grains, fruits, and vegetables. The size of the grocery delivery is adjusted for the number of people living in the household. In addition to the grocery delivery, one of our Registered Dietitians will speak with these participants a total of 8 times during the 6-month study. These sessions with the dietitian can be done via telephone or videoconference (e.g., Zoom) and each session will last about 30 minutes. The sessions will occur in Week 1, Week 2, Week 4, Week 6, Week 9, Week 12, Week 16, and Week 20. These participants will also receive a free book that contains written information related to the counseling sessions as well as a recipe book. They will also have the option to pick-up fresh produce (fruits and vegetables) once per week from clinic locations served by the Christine B. Foundation during the study.

Primary Outcome Measure

Diet Quality [ Time Frame: Change from baseline to 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale School of Public HealthNew HavenConnecticut06510
Leah M Ferrucci, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Yale School of Public Health· New Haven, CT

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