Nutrition Counseling for Cancer

Overseen By Leah M Ferrucci

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Regular dietitian visits, IV nutrition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 6 months

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how different food support approaches can improve the diets of people with cancer in specific parts of Maine. Participants will be divided into three groups: one will receive weekly deliveries of medically tailored groceries, another will receive the same groceries plus nutrition counseling, and the third will receive standard care with delayed grocery delivery. The goal is to determine which method most effectively improves diet quality, healthcare visits, and quality of life. Individuals who have had cancer and live in Hancock, Penobscot, Washington, or Piscataquis counties in Maine may qualify if they are not regularly seeing a dietitian or receiving certain types of nutrition support. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance dietary support for cancer patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on nutrition counseling and grocery delivery for cancer patients.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that medically tailored groceries are generally safe for people with cancer. Studies have found that these programs can improve diet quality and help reduce food insecurity. No strong evidence indicates any harmful effects from providing foods that meet specific medical needs.

Research also supports the safety of combining medically tailored groceries with nutrition counseling. Nutritional counseling has proven safe for patients undergoing chemotherapy and can improve nutritional health without causing harm.

Both treatments appear well-tolerated based on available information, with no major reports of negative effects linked to these interventions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Nutrition Counseling for Cancer trial because it explores a holistic approach to supporting cancer patients through nutrition. Unlike typical cancer treatments, which often focus solely on medical or surgical interventions, this trial emphasizes the role of diet and nutrition in managing health. The trial includes two unique arms: the Medically Tailored Grocery (MTG) program, which delivers personalized groceries to meet dietary needs, and the MTG Plus Nutrition Counseling program, which adds regular sessions with a registered dietitian to provide guidance and support. By focusing on personalized nutrition and direct dietary support, researchers hope to enhance patients' well-being, potentially improving outcomes and quality of life during cancer treatment.

What evidence suggests that this trial's treatments could be effective for cancer patients?

Research has shown that specially prepared groceries can improve diet and health for people with cancer. One study found that these meals reduced hospital visits and lowered healthcare costs. This is crucial for cancer patients, who often face poor nutrition, longer hospital stays, and a lower quality of life.

In this trial, participants in the Medically Tailored Grocery Plus Nutrition Counseling Group will receive both groceries and nutrition counseling. Adding nutrition counseling appears to enhance these benefits. Studies indicate that this combination helps patients adjust better to their treatment and improve their overall well-being. It's about using food as part of the healing process, and early results are promising. ^{3 4 6 7 8}

Who Is on the Research Team?

Leah M Ferrucci, PhD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have been diagnosed with cancer and live in Hancock, Penobscot, Washington, or Piscataquis county in Maine. They must be able to stay in the area for the next six months.

Inclusion Criteria

I will live in Hancock, Penobscot, Washington, or Piscataquis county in Maine for the next 6 months.

I am 18 years old or older.

I have been diagnosed with cancer before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive medically tailored groceries with or without nutrition counseling for 6 months

6 months

Weekly grocery delivery, 8 counseling sessions (virtual)

Follow-up

Participants are monitored for changes in diet quality, food insecurity, healthcare utilization, quality of life, and cancer-treatment related symptoms

4 weeks

Delayed Treatment

Standard of care group receives delayed medically tailored grocery delivery for 6 months

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Medically Tailored Grocery
• Medically Tailored Grocery Plus Nutrition Counseling
• Standard of Care with Delayed Medically Tailored Grocery Delivery

Trial Overview The study tests how a 6-month program of medically tailored grocery delivery plus nutrition counseling compares to just grocery delivery or standard care among cancer patients. It looks at diet quality changes and impacts on health service use, malnutrition, symptoms, food security, life quality, and financial strain.

How Is the Trial Designed?

Group I: Medically Tailored Grocery Plus Nutrition Counseling Group Experimental Treatment 1 Intervention

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.

Group II: Medically Tailored Grocery Group Experimental Treatment 1 Intervention

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.

Group III: Standard of Care Group with Delayed Medically Tailored Grocery Delivery Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Christine B. Foundation

Collaborator

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/jco.2016.34.26_suppl.155

Food as medicine: A randomized controlled trial (RCT) of ... Malnourished patients have impaired chemotherapy response, shorter survival, longer hospital stays, and decreased QoL. Home delivered meals are ...

2. foodandfriends.org foodandfriends.org/news/new-studies-show-medically-tailored-meal-programs-improve-health-and-reduce-healthcare-costs/

New Studies Show Medically Tailored Meal Programs ... The other study was conducted with Maryland's Community Health Services Commission (CHRC), which reported outcome data for 58 clients over 24 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0749208124002833

Nutrition Care in Cancer: An Overlooked Part of Patient- ... We aim to emphasize the critical role of nutrition care for cancer patients and to highlight the essential contributions of nurses in providing patient- ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10862975/

How a Medically Tailored Meal Intervention with Intensive ... The purpose of this study was to assess participants' perceptions and experiences while participating in a Food is Medicine medically tailored meal plus ...

5. healthaffairs.org healthaffairs.org/doi/10.1377/hlthaff.2024.01307

Estimated Impact Of Medically Tailored Meals On ... This study investigated the one-year and five-year effects of implementing MTMs in US states on hospitalizations, health care expenditures, and net costs.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9745434/

Food Insecurity Among People With Cancer: Nutritional ... Estimates of the percentage of people navigating a cancer diagnosis and food insecurity range between 17% and 55% of the cancer patient ...

7. jamanetwork.com jamanetwork.com/journals/jama-health-forum/fullarticle/2835283

Mortality Outcomes for Survivors of Cancer With Food ... We observed 546 deaths due to cancer, with a median follow-up of 7.8 years (IQR, 7.3-8.3 years, range, 0-8.9 years), including 65 deaths ...

8. dhcs.ca.gov dhcs.ca.gov/Documents/MCQMD/May-Community-Supports-Spotlight-Medically-Tailored-Meals.pdf

CalAIM Community Supports Spotlight - Medically Tailored ... Meal Delivery for Diabetes Patients with Food Insecurity, found that medically tailored meals improved dietary quality and food insecurity ...