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Active, Not Recruiting

NCT Number: NCT07076004

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale School of Public Health

New Haven, Connecticut, 06510, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Diet Quality

    Time frame: Change from baseline to 6 months

    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.

Secondary outcomes

  1. Food Insecurity

    Time frame: Change from baseline to 6 months

    United Stated Department of Agriculture 6-item questionnaire; range of 0-6, higher score indicating lower food security.

  2. Health Related Quality of Life

    Time frame: Change from baseline to 6 months

    12-item Short Form Survey (SF-12) will be used to generate the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Using norm based scores, above 50 indicate a better-than-average health-related quality of life.

  3. Cancer-Treatment Related Symptoms

    Time frame: Change from baseline to 6 months

    Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Count of number of symptoms.

  4. Healthcare Utilization

    Time frame: Number from baseline to 6 months

    Self-reported visits and admissions to emergency rooms, urgent care clinics, and in-patient facilities.

  5. Malnutrition

    Time frame: Change from baseline to 6 months

    Patient-Generated Subjective Global Assessment (PG-SGA); range of 0-33, higher score indicating greater likelihood of malnutrition.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Christine B. Foundation

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 20, 2025
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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