RecruitingInterventional

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

NCT ID: NCT07076004Sponsor: Yale UniversityLast 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.

Detailed description

The purpose of this study is to assess the effect of a 6-month intervention of medically tailored groceries plus nutrition counseling vs. medically tailored groceries alone vs. standard of care on diet and health outcomes among 100 cancer survivors who reside in Maine. This project will be conducted in partnership with the Christine B. Foundation which has been delivering medically tailored groceries to cancer survivors in Maine since 2020, but has not yet evaluated the impact of this nutrition program on important health outcomes in people living with cancer. The eligibility criteria matched the population of cancer survivors currently served by the Christine B. Foundation as we are testing the effect of their services on health-related outcomes in their target population. Given medically tailored meals and groceries have conferred health benefits in other patient populations, but there is limited research among cancer survivors, this highly innovative study and could provide evidence on the potential benefits of this type of nutrition intervention specifically for cancer survivors.

Arms & interventions

BehavioralMedically Tailored Grocery Plus Nutrition Counseling Group
Weekly delivery of medically tailored groceries plus 8 remote nutritional counselling sessions.
BehavioralExperimental: Medically Tailored Grocery Group
Weekly delivery of medically tailored groceries.
BehavioralStandard 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.

Outcome measures

Primary

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.
Time frame: Change from baseline to 6 months

Secondary

Food Insecurity
Time frame: Change from baseline to 6 months
Health Related Quality of Life
Time frame: Change from baseline to 6 months
Cancer-Treatment Related Symptoms
Time frame: Change from baseline to 6 months
Healthcare Utilization
Time frame: Number from baseline to 6 months
Malnutrition
Time frame: Change from baseline to 6 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: Yes

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Study locations (1)

Yale School of Public Health

New Haven, Connecticut, 06510

Recruiting

Leah M Ferrucci, PhD · Principal Investigator