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ACTIVE NOT RECRUITING
NCT01603316
PHASE2

Food: A Three-Arm Study Examining Food Insecurity Interventions

Sponsor: Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

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.

Official title: Food: A Three-Arm Randomized Controlled Study Examining Food Insecurity Interventions

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

606

Start Date

2012-05-08

Completion Date

2026-05

Last Updated

2026-03-12

Healthy Volunteers

No

Conditions

Interventions

BEHAVIORAL

surveys

Each survey will take about 45 minutes.Surveys will include questions on medical treatment, health insurance, work-related information, overall health and well being, eating habits, and satisfaction/use of the food program provided. 3 and 6-month follow-up. All participants will be asked to complete the study contact form. Need Assessment surveys will be administered via telephone or in person. The content of the needs assessment questionnaire has been informed by themes generated through IHCD's ongoing research and community outreach and service activities with the cancer patient population at our participating institutions. The survey will ask participants about the impact on their cancer care and their socioeconomic needs of the COVID-19 crisis.

BEHAVIORAL

Focus groups

Prior to conducting the updated RCT design with the expanded cohort, we will conduct 4-6 focus groups (to saturation) with underserved breast cancer patients to optimally tailor the written materials, via mail, MSK Secure email, or in person and nutrition education sessions.

Locations (10)

Brooklyn Hospital Center

Brooklyn, New York, United States

Queens Hospital Center

Jamaica, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Bellevue Hospital Center

New York, New York, United States

Ralph Lauren Center for Cancer Care and Prevention

New York, New York, United States

St. Barnabas Medical Center

The Bronx, New York, United States

Jacobi Medical Center

The Bronx, New York, United States

Montefiore Health System (Montefiore Medical Center)

The Bronx, New York, United States

New York Cancer & Blood Specialists (Data collection only)

The Bronx, New York, United States

Lincoln Medical and Mental Health Center

The Bronx, New York, United States