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

NCT07076004 | Recruiting

• 1 other identifier: 2000039692
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Cancer

Keywords

Medically tailored grocery delivery; Diet Quality

Outcome Measures

Primary Outcomes (1)

• Diet 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.

  Change from baseline to 6 months

Secondary Outcomes (5)

• Food Insecurity

  Change from baseline to 6 months

• Health Related Quality of Life

  Change from baseline to 6 months

• Cancer-Treatment Related Symptoms

  Change from baseline to 6 months

• Healthcare Utilization

  Number from baseline to 6 months

• Malnutrition

  Change from baseline to 6 months

Study Arms (3)

Standard of Care Group with Delayed Medically Tailored Grocery Delivery

ACTIVE COMPARATOR

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.

Behavioral: Standard of Care Group with Delayed Medically Tailored Grocery Delivery

Medically Tailored Grocery Group

EXPERIMENTAL

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.

Behavioral: Experimental: Medically Tailored Grocery Group

Medically Tailored Grocery Plus Nutrition Counseling Group

EXPERIMENTAL

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.

Behavioral: Medically Tailored Grocery Plus Nutrition Counseling Group

Interventions

Medically Tailored Grocery Plus Nutrition Counseling Group BEHAVIORAL

Weekly delivery of medically tailored groceries plus 8 remote nutritional counselling sessions.

Medically Tailored Grocery Plus Nutrition Counseling Group

Experimental: Medically Tailored Grocery Group BEHAVIORAL

Weekly delivery of medically tailored groceries.

Medically Tailored Grocery Group

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.

Standard of Care Group with Delayed Medically Tailored Grocery Delivery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Ever been diagnosed with cancer
• Reside Hancock, Penobscot, Washington or Piscataquis county in Maine for the next 6 months

You may not qualify if:

• Seeing a dietitian regularly (at least once every two weeks)
• 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.

Sponsors & Collaborators

• Yale University: lead
• Christine B. Foundation: collaborator

Study Sites (1)

Yale School of Public Health

New Haven, Connecticut, 06510, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Leah M Ferrucci, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leah M Ferrucci

CONTACT

203-785-6232; leah.ferrucci@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 20, 2025
• Study Start: July 30, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)