Malnutrition Clinical Trials

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

Status: Recruiting

Location: See location...

Intervention Type: Behavioral

Study Type: Interventional

Study Phase: Not Applicable

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.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 18

Healthy Volunteers: t

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• 18 years of age or older

• Ever been diagnosed with cancer

• Reside Hancock, Penobscot, Washington or Piscataquis county in Maine for the next 6 months

Locations

United States

Connecticut

Yale School of Public Health

RECRUITING

New Haven

Contact Information

Primary

Leah M Ferrucci

leah.ferrucci@yale.edu

203-785-6232

Time Frame

Start Date: 2025-07-30

Estimated Completion Date: 2026-09

Participants

Target number of participants: 100

Treatments

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.

Related Therapeutic Areas

Malnutrition

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