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Food: A Three-Arm Study Examining Food Insecurity Interventions

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01603316
Enrollment
606
Registered
2012-05-22
Start date
2012-05-08
Completion date
2027-05-01
Last updated
2026-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Patients

Keywords

Food pantry, Food voucher, Grocery delivery, 12-099

Brief 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.

Interventions

BEHAVIORALsurveys

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.

BEHAVIORALFocus 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.

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER
Queens Cancer Center of Queens Hospital
CollaboratorOTHER
The Brooklyn Hospital Center
CollaboratorOTHER
Lincoln Medical and Mental Health Center
CollaboratorOTHER
Jacobi Medical Center
CollaboratorOTHER
St. Barnabas Medical Center
CollaboratorOTHER
Montefiore Health System
CollaboratorUNKNOWN
Columbia University
CollaboratorOTHER
Roswell Park Cancer Institute
CollaboratorOTHER
NYU Langone Health
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Focus Groups Inclusion Criteria: * Breast cancer patient, Stage 1,2, or 3 * Currently undergoing treatment with chemotherapy and/or radiation * Food insecure: score in the range of "very low" or "low" food security status on the USDA Household Food Security Module (score of 3 or higher) * Language spoken: English or Spanish * Age 18 or over 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) Clinician is eligible if he/she: * Has an MD or DO degree * Is the treating physician providing care to a patient enrolled to the study Secondary Aim 6 Needs Assessment eligibility criteria: * Current or past breast cancer diagnosis * 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, or Spanish

Exclusion criteria

Focus Groups

Design outcomes

Primary

MeasureTime frameDescription
treatment completion2 yearsCompletion of prescribed treatment, increase from 75% to 94%, as assessed by chart review (for the period from recruitment to study completion at 6 months). To determine whether participation in the interventions leads to improvements in cancer treatment completion.

Secondary

MeasureTime frameDescription
Quality of life2 yearsThe primary analytic approach for these secondary outcome variables will be a series of Linear Mixed-Effects Models (LMMS) modeling the change scores from baseline to each of the follow-up assessments, separately for each of the questionnaire outcome variables \[51\]. Analyses based on change scores have the advantage of creating easily interpretable results and clearly indicating the direction of individual change (e.g., increased protein intake).

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORFrancesca Gany, MD, MS

Memorial Sloan Kettering Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 10, 2026