Food Assistance Interventions for Cancer Patients

Recruiting at 15 trial locations

Overseen By Francesca Gany, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Psychiatric disturbance, Cognitive impairment, SNAP, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

668 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the best way to support cancer patients who struggle to get enough food during treatment, which can hinder their ability to complete care. The study compares three options: a hospital-based food pantry, monthly food vouchers, and weekly grocery deliveries. Participants will be randomly assigned to one of these groups, similar to drawing straws. The trial seeks breast or gynecologic cancer patients in stages 1, 2, or 3 who are currently in treatment and have difficulty accessing sufficient food. As a Phase 2 trial, this research focuses on measuring the effectiveness of the treatment in an initial, smaller group of people.

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 seems focused on food assistance, so it's unlikely to require changes to your medication, but you should confirm with the trial coordinators.

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

Research has shown that both home grocery delivery and food voucher programs are generally safe and well-received by participants. Studies have found that these programs improve food security for cancer patients, which is crucial for completing their treatment. For instance, one study found that patients using a grocery delivery service completed their treatment at a high rate of 82.5%, indicating the program's manageability for most people.

The hospital-based food pantry, tailored to medical needs, has also been used with low-income cancer patients and has shown positive results in improving food security without major side effects. These food support programs are designed to provide essential nutrition, helping patients adhere to their cancer treatments more effectively.

Since the trial is in Phase 2, some existing evidence supports safety, but more data is being collected to confirm these findings. Overall, these programs are not only safe but also play a crucial role in supporting cancer patients who have difficulty obtaining enough food. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these interventions because they aim to provide innovative support for cancer patients facing food insecurity, which is not typically addressed by standard cancer treatments like chemotherapy or radiation. The Home Grocery Delivery service offers the convenience of having groceries delivered directly to patients' homes, tailored to their dietary needs and preferences, making nutrition management easier. The Food Voucher Program provides a flexible financial resource specifically for purchasing food, empowering patients to make healthier food choices while managing their budgets. Lastly, the Medically-Tailored Hospital-Based Food Pantry gives patients access to customized food selections that meet their medical and cultural needs, integrated conveniently with their hospital visits. These interventions explore how addressing food needs can improve overall health and quality of life for cancer patients.

What evidence suggests that this trial's food assistance interventions could be effective for cancer patients?

Research has shown that food assistance can significantly help cancer patients complete their treatment. In this trial, participants will receive different food assistance interventions. One study found that patients who received grocery deliveries, similar to the Home Grocery Delivery arm in this trial, had an 82.5% treatment completion rate. Another study demonstrated that food pantry programs, like the Medically-Tailored Hospital-Based Food Pantry arm, improved diet-related health for participants. Patients using a special food pantry designed for their medical needs reported better control of symptoms such as nausea and anxiety. Overall, food support through vouchers, grocery delivery, and specialized pantries, as tested in this trial, can be crucial in helping cancer patients maintain a healthy diet and adhere to their treatment plans. ^{4 5 6 7 8}

Who Is on the Research Team?

Francesca Gany, MD, MPH

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adult cancer patients in New York City who are starting or undergoing chemotherapy or radiation, and have very low to low food security. They must live independently, be able to consent and answer questions in English, Spanish, or Mandarin (for some arms), and not be receiving SNAP benefits. It's specifically for those with breast or gynecologic cancer at stages 1-3 for certain study arms.

Inclusion Criteria

I have or had breast cancer, live on my own, am over 18, and can complete forms in English or Spanish.

I am a breast cancer patient in stages 1-3, currently on chemo or radiation, facing food insecurity, and speak English or Spanish.

Intervention Inclusion Criteria: Enrolled in ICCAN (for the original arms only: pantry only, pantry + delivery, pantry + voucher); Within one month (+/- 1 month) of starting chemotherapy or within two weeks (+/- 2 weeks) of starting radiation therapy) (may be prior to or after starting treatment); Score in the range of 'very low' or 'low' food security status on the USDA Household Food Security Module (score of 3 or higher); Living independently (no patient in an assisted living facility); Age 18 or over; Able to provide informed consent and respond to questionnaires in either English, Spanish or Mandarin (Mandarin for the original arms only: pantry only, pantry + delivery, pantry + voucher); Breast or gynecologic cancer diagnosis, Stage 1, 2, or 3 (for the updated arms only: 1) Food Voucher Program (Voucher); 2) Home Grocery Delivery Program (Delivery); and 3) Medically-tailored, Hospital-based Food Pantry (Pantry)

Exclusion Criteria

Focus Groups Exclusion Criteria: Has a household member who has already participated (or agreed to participate)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to one of three food assistance programs: Home Grocery Delivery, Food Voucher Program, or Medically-Tailored Hospital-Based Food Pantry, for 6 months.

6 months

Monthly visits for voucher pickup or receipt review

Follow-up

Participants are monitored for treatment completion and quality of life improvements after the intervention

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Focus groups
• surveys

Trial Overview

The study examines three interventions aimed at addressing food insecurity among cancer patients: a hospital-based food pantry, monthly food vouchers plus pantry access, and weekly grocery deliveries plus pantry access. Patients will be randomly assigned to one of these groups to determine which method best supports completing their cancer treatment.

How Is the Trial Designed?

Group I: Medically-Tailored Hospital-Based Food Pantry (Pantry) Experimental Treatment 2 Interventions

Patients in this arm will have access to the pantry for the duration of their study participation (6 months). Those accessing the medically-tailored food pantry will pick-up a pantry bag weekly or bi-weekly (per patient preference) at the hospital, either during one of their medical appointments or at another preferred time. Each patient's food prefereces will be assessed once during baseline and they will be given food bags, tailored when possible and when available to these preferences and to their medical needs and cultural preferences.

Group II: Home Grocery Delivery (Delivery) Experimental Treatment 2 Interventions

In the Home Grocery Delivery arm, each participant will receive home grocery delivery from PeaPod grocery delivery service or from FreshDirect (depending on the participant"s zip code), worth $128 per month, for the duration of study participation (6 months). Patients in the Delivery arm will review a list of food categories and a subset of items in each category with a COA.

Group III: Food Voucher Program (Voucher) Active Control 2 Interventions

Food Voucher arm, each participant will receive a debit card specifically created for this program. Each month for the duration of study participation (6 months), the debit card will be credited with $128 \& given to the patient in person or via mail. Patients will be instructed to use these cards only for food purchases. If patients are not able to use the debit card at their local grocery stores, patients will be provided with a money order of the same dollar value instead of the debit card. They will be counseled on using their vouchers only for healthful foods, in a way that stretches their food dollars. Purchases will be tracked by having patients bring their receipts in for review each month when they come in to pick-up their next monthly vouche, or by providing electronic copies of receipts. Patients will be provided with a receipt holder to assist in storing receipts for review. For voucher cards sent via mail, patients will receive a mailing letter accompanying each card.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Lincoln Medical and Mental Health Center

Collaborator

Trials

11

Recruited

2,100+

Montefiore Health System

Collaborator

Trials

1

Recruited

670+

Queens Cancer Center of Queens Hospital

Collaborator

Trials

9

Recruited

1,100+

The Brooklyn Hospital Center

Collaborator

Trials

9

Recruited

2,100+

Jacobi Medical Center

Collaborator

Trials

24

Recruited

4,500+

St. Barnabas Medical Center

Collaborator

Trials

13

Recruited

2,800+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

Roswell Park Cancer Institute

Collaborator

Trials

427

Recruited

40,500+

NYU Langone Health

Collaborator

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

A 3-year nutritional workshop for cancer patients, involving 56 participants (91% women), provided valuable information on nutrition and psychosocial support, helping to address the psychological and nutritional challenges faced by these patients.

The workshops, which included diet education and supportive group sessions, were believed to enhance social reintegration and emotional expression, indicating their potential benefit in humanizing cancer treatment, although the current evaluation is subjective and a more systematic study is underway.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nutritional workshops for cancer patients: a pilot approach]. Mouysset, JL., Baciuchka-Palmaro, M., Ichou, M., et al.[2019]

A study involving interviews with 31 cancer patients and 17 clinicians identified key nutrition-related goals for patients, including weight maintenance, improved food satisfaction, and enhanced quality of life.

Both patients and clinicians emphasized the importance of patients having control over their food choices and receiving meals they enjoy, which will inform the development of a patient-centered assessment tool for nutrition interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Important Needs and Goals Related to Nutrition Interventions during Cancer Treatment. Foecke Munden, E., Kemp, M., Guth, A., et al.[2023]

The NOA project successfully increased the integration of nutritional evaluations in cancer care plans across three hospitals in Andalusia, leading to more comprehensive support for patients over a six-month period.

Enhanced participation of the Nutrition Support Team in tumor boards, especially for head and neck and oesophagogastric cancers, has improved the management of malnutrition in cancer patients, demonstrating the importance of nutrition in oncological care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Nutritional Interventions in the Care Plan for Cancer Patients: The NOA Project. García-Luna, PP., Rabat Restrepo, JM., Muñoz-Ayllón, M., et al.[2023]

A study involving 351 low-income urban cancer patients at food pantries in New York City found that the average number of visits to the pantry was 3.25 over four months, indicating a moderate level of engagement with the food assistance program.

Younger patients were less likely to use the pantry, while immigrant patients and those with prostate or Stage IV cancer were more likely to utilize the service, highlighting the need for targeted outreach to at-risk groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Hospital-Based Food Pantries Among Low-Income Urban Cancer Patients. Gany, F., Lee, T., Loeb, R., et al.[2018]

A study of 60 food pantries in New York City revealed that they are not adequately meeting the needs of medically ill cancer patients, highlighting significant barriers such as limited service hours and strict documentation requirements.

The pantries provided insufficient quantities of food and lacked a variety of nutritious options, indicating a need for more emergency food resources and long-term support for patients during their treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food insecurity: limitations of emergency food resources for our patients. Gany, F., Bari, S., Crist, M., et al.[2021]

Nutrition plays a crucial role in the health of cancer patients and survivors, providing them with empowerment and support during their treatment journey, as highlighted by a qualitative study involving 12 oncology providers and 12 survivors.

The proposed 'NutriCare' program was well-received, particularly the idea of using a prescription pad for nutrition advice, but barriers such as time constraints and provider motivation need to be addressed for effective implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceptions of Oncology Providers and Cancer Survivors on the Role of Nutrition in Cancer Care and Their Views on the "NutriCare" Program. Keaver, L., Yiannakou, I., Folta, SC., et al.[2021]

In a study involving 33 cancer patients receiving food vouchers, participants spent 50% of their funds on healthy items like animal protein, fruits, and vegetables, indicating a positive shift in their food purchasing behaviors.

The supplemental food voucher program led to patients purchasing more healthy foods than national averages, particularly among those born outside the U.S. or with limited English proficiency, highlighting the program's potential effectiveness in improving dietary choices for food insecure cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food Purchasing Behavior of Food Insecure Cancer Patients Receiving Supplemental Food Vouchers. Paolantonio, L., Kim, SY., Ramirez, J., et al.[2023]

The 8-week personalized nutrition intervention for mobile food pantry users resulted in a significant average weight loss of 2.3% among participants, indicating its effectiveness in promoting weight management.

While the treatment group showed a greater improvement in diet quality compared to the control group, this change was not statistically significant, suggesting that while the intervention is promising, further research is needed to confirm its impact on dietary habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Feasibility and Pilot Study of a Personalized Nutrition Intervention in Mobile Food Pantry Users in Northeastern Connecticut. Marmash, D., Ha, K., Sakaki, JR., et al.[2021]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11679311/

Evaluating the Impact of a Novel Program to Address Acute ...

Two weeks after receiving groceries, patients reported a decrease in nausea (pre: 1.34; post: 1.18) and anxiety related to their cancer (pre: ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9622577/

A Randomized Controlled Trial of Food Insecurity ...

Voucher plus pantry had the highest treatment completion rate (94.6%), followed by grocery delivery plus pantry (82.5%) and pantry (77.5%; P = .046). Food ...

3.

ascopubs.org

ascopubs.org/doi/abs/10.1200/JCO.21.02400

Food to Overcome Outcomes Disparities: A Randomized ...

Voucher plus pantry had the highest treatment completion rate (94.6%), followed by grocery delivery plus pantry (82.5%) and pantry (77.5%; P = .

4.

clinicaltrials.gov

clinicaltrials.gov/ct2/show/NCT05889780

Screening for and Responding to Food Insecurity Among ...

In addition to clinic referrals, researchers have found the addition of monthly grocery vouchers or home grocery delivery to be even more effective at improving ...

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familyreach.org

familyreach.org/wp-content/uploads/2025/07/Interventions-addressing-health-related-social-needs-among-patients-with-cancer.pdf

Interventions-addressing-health-related-social-needs- ...

It is estimated that approximately 25%-60% of patients with cancer experience food insecurity, 20% suffer from housing instability, and 15% ...

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/35709430/

A Randomized Controlled Trial of Food Insecurity ... - PubMed

Results: Voucher plus pantry had the highest treatment completion rate (94.6%), followed by grocery delivery plus pantry (82.5%) and pantry ( ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT06602999

Addressing the Nutritional Needs of Cancer Survivors With ...

This clinical trial studies whether the use of a grocery delivery service (Instacart) and nutrition navigation improves food insecurity in cancer survivors.

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clinicaltrial.be

clinicaltrial.be/en/details/75458?per_page=100&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

A Three-Arm Study Examining Food Insecurity Interve...

Our modified RCT, to be carried out among an expanded cohort of cancer patients is composed of study arms : 1) Food Voucher Program (Voucher); 2) Home Grocery ...