CancerNCT07076004
Nourishing Hope: The Impact of Nutrition in Cancer Treatment and Recovery in Maine
A study testing Medically Tailored Grocery Plus Nutrition Counseling Group and Experimental: Medically Tailored Grocery Group in people with Cancer, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Medically Tailored Grocery Plus Nutrition Counseling Group and Experimental: Medically Tailored Grocery Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2025to 17 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale School of Public Health
New Haven, Connecticut, 06510
About this study
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Medically Tailored Grocery Plus Nutrition Counseling Group, Experimental: Medically Tailored Grocery Group, Standard of Care Group with Delayed Medically Tailored Grocery Delivery
- Keywords
- Medically tailored grocery delivery, Diet Quality
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medically Tailored Grocery Plus Nutrition Counseling GroupBehavioural
Weekly delivery of medically tailored groceries plus 8 remote nutritional counselling sessions.
Experimental: Medically Tailored Grocery GroupBehavioural
Weekly delivery of medically tailored groceries.
Standard of Care Group with Delayed Medically Tailored Grocery DeliveryBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Medically Tailored Grocery Plus Nutrition Counseling Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to 6 months
Secondary outcomes (5)
Food Insecurity
United Stated Department of Agriculture 6-item questionnaire; range of 0-6, higher score indicating lower food security.
Measured: Change from baseline to 6 months
Health Related Quality of Life
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.
Measured: Change from baseline to 6 months
Cancer-Treatment Related Symptoms
Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Count of number of symptoms.
Measured: Change from baseline to 6 months
Healthcare Utilization
Self-reported visits and admissions to emergency rooms, urgent care clinics, and in-patient facilities.
Measured: Number from baseline to 6 months
Malnutrition
Patient-Generated Subjective Global Assessment (PG-SGA); range of 0-33, higher score indicating greater likelihood of malnutrition.
Measured: Change from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start30 Jul 2025
- Primary completion17 Jan 2027 (estimated)
- Study completion17 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Christine B. Foundation
- Responsible party
- Sponsor
- Investigators
- Leah M Ferrucci, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07076004
- Sponsor's protocol ID
- 2000039692
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2025
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nourishing Hope: The Impact of Nutrition in Cancer Treatment and Recovery in Maine
- ClinicalTrials.gov ID
- NCT07076004
- Acronym / sponsor ID
- 2000039692
- Conditions
- Cancer
- Keywords
- Medically tailored grocery delivery, Diet Quality
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Christine B. Foundation
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- 17 Jan 2027 (estimated)
- Study completion
- 17 Jan 2027 (estimated)
- First posted
- 20 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Group with Delayed Medically Tailored Grocery Delivery | Active comparator | Behavioral: Standard of Care Group with Delayed Medically Tailored Grocery DeliveryOption 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. |
| Medically Tailored Grocery Group | Experimental | Behavioral: Experimental: Medically Tailored Grocery GroupA 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. |
| Medically Tailored Grocery Plus Nutrition Counseling Group | Experimental | Behavioral: Medically Tailored Grocery Plus Nutrition Counseling GroupDelivery 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medically Tailored Grocery Plus Nutrition Counseling GroupWeekly delivery of medically tailored groceries plus 8 remote nutritional counselling sessions. | Behavioural | Medically Tailored Grocery Plus Nutrition Counseling Group |
| Experimental: Medically Tailored Grocery GroupWeekly delivery of medically tailored groceries. | Behavioural | Medically Tailored Grocery Group |
| Standard of Care Group with Delayed Medically Tailored Grocery DeliveryOption 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. | Behavioural | Standard of Care Group with Delayed Medically Tailored Grocery Delivery |
Primary outcome
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leah M Ferrucci, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medically Tailored Grocery Plus Nutrition Counseling Group and Experimental: Medically Tailored Grocery Group in people with Cancer, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diet Quality (time frame: Change from baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.