Nourishing Hope: The Impact of Nutrition in Cancer Treatment and Recovery in Maine
NCT ID: NCT07076004
Last Updated: 2025-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2025-07-30
2026-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
SINGLE
Study Groups
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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.
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.
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 Group
Weekly delivery of medically tailored groceries.
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.
Medically Tailored Grocery Plus Nutrition Counseling Group
Weekly delivery of medically tailored groceries plus 8 remote nutritional counselling sessions.
Interventions
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Medically Tailored Grocery Plus Nutrition Counseling Group
Weekly delivery of medically tailored groceries plus 8 remote nutritional counselling sessions.
Experimental: Medically Tailored Grocery Group
Weekly delivery of medically tailored groceries.
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.
Eligibility Criteria
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Inclusion Criteria
* Ever been diagnosed with cancer
* Reside Hancock, Penobscot, Washington or Piscataquis county in Maine for the next 6 months
Exclusion Criteria
* Planned long-term inpatient cancer treatment
* Receiving nutrition via IV also known as total parenteral nutrition
* Getting nutrition through a feeding tube
* Drinking more than 3 bottles of liquid meal replacements, such as Ensure, per day
* Received grocery delivery or grocery (not produce only) pick-up from the Christine B. Foundation in the past 3 months.
* Those with reduced mental capacity and unable to understand all the components of the study, including the details of randomization.
18 Years
ALL
Yes
Sponsors
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Christine B. Foundation
UNKNOWN
Yale University
OTHER
Responsible Party
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Principal Investigators
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Leah M Ferrucci, PhD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale School of Public Health
New Haven, Connecticut, United States
Countries
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Central Contacts
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Other Identifiers
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2000039692
Identifier Type: -
Identifier Source: org_study_id
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