Food Assistance Interventions for Cancer Patients

Recruiting at 10 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

Trial Summary

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.

What data supports the effectiveness of the treatment Food Assistance Interventions for Cancer Patients?

Research shows that cancer patients benefit from nutritional support, which can help maintain weight, improve food satisfaction, and enhance quality of life by reducing stress. Hospital-based food pantries and nutritional workshops have been positively received, indicating that food assistance can be a valuable part of cancer care. ^{1 2 3 4 5}

Is food assistance safe for cancer patients?

The research does not report any safety concerns related to food assistance programs for cancer patients, suggesting they are generally safe for human use. ^{4 5 6 7 8}

How does the food assistance intervention differ from other treatments for cancer patients?

This treatment is unique because it focuses on providing food assistance to cancer patients, addressing food insecurity which can impact their health outcomes and quality of life. Unlike traditional cancer treatments that target the disease directly, this intervention aims to improve nutritional support and reduce stress related to food access, which can indirectly benefit patients' overall well-being during cancer care. ^{1 4 5 6 7}

What is the purpose of this trial?

The investigators have found that many patients getting treatment for cancer have trouble getting enough to eat, or do not always have enough money for food. When a patient has these problems it can lead to difficulties with completing cancer treatment. Across New York City, there are many hospitals that offer their patients food pantry services on location. The investigators would like to compare how food pantries within the hospital and two other food assistance options: monthly food vouchers and weekly grocery deliveries maybe possible solutions to this problem. The patient will be randomly assigned to one of the three different food program groups, which means everyone has an equal chance in being in any group, like a flip of a coin. The investigators hope to learn how to best help patients with trouble getting food and to see if this will help with completing cancer treatment. The original RCT composed of study arms: 1) hospital -based food pantry (control), 2) food voucher program plus access to the food pantry, and 3) grocery delivery program plus access to the food pantry will remain open to accrual at Ralph Lauren Cancer Center. The other three sites of the original RCT, Lincoln Hospital, Queens Cancer Center and Brooklyn Hospital, have reached target accrual. 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 Delivery Program (Delivery); and 3) Medically-tailored, Hospital-based Food Pantry (Pantry). For this RCT, we will enroll patients across Bronx hospitals- Jacobi Medical Center, St. Barnabas Hospital, and Montefiore Medical Center. For the new study arms, we will enroll patients across Lincoln Medical and Mental Health Center, Jacobi Medical Center, St. Barnabas Medical Center, Montefiore Health System, New York Cancer \& Blood Before Specialists, and Bellevue Hospital. Before conducting the RCT across Lincoln Medical and Mental Health Center and the new sites in the Bronx, we will refine written educational materials to be used in the intervention through focus groups.

Research Team

Francesca Gany, MD, MPH

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Patient-Important Needs and Goals Related to Nutrition Interventions during Cancer Treatment. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluation of Nutritional Interventions in the Care Plan for Cancer Patients: The NOA Project. [2023]

3. France pubmed.ncbi.nlm.nih.gov

[Nutritional workshops for cancer patients: a pilot approach]. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Use of Hospital-Based Food Pantries Among Low-Income Urban Cancer Patients. [2018]

5. Switzerland 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. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Food insecurity: limitations of emergency food resources for our patients. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Food Purchasing Behavior of Food Insecure Cancer Patients Receiving Supplemental Food Vouchers. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

A Feasibility and Pilot Study of a Personalized Nutrition Intervention in Mobile Food Pantry Users in Northeastern Connecticut. [2021]