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Food Assistance Interventions for Cancer Patients

Phase 2
Recruiting
Led By Francesca Gany, MD, MS
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Intervention Exclusion Criteria: Significant psychiatric disturbance verified by medical record sufficient to preclude completion of the assessment measures, interview or informed consent (i.e. acute psychiatric symptoms which require individual treatment); Presence of cognitive impairment disorder (i.e. delirium or dementia) sufficient to preclude meaningful informed consent and/or data collection; Can not speak English, Spanish or Mandarin (Mandarin for the original arms only: pantry only, pantry + delivery, pantry + voucher); Has physical limitations that would prevent participation (e.g. blindness); Patient's household is currently receiving or applying for SNAP benefits (formerly known as Food Stamps) (for the original arms only: pantry only, pantry + delivery,pantry + voucher)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Summary

This trial is testing whether food pantries, food vouchers, or grocery delivery help cancer patients who have trouble getting food.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since the interventions involve non-medical support (food assistance programs), there are no direct medical side effects expected from participating in this trial. However, participants may experience emotional or social impacts related to the adequacy of the intervention in meeting their nutritional needs.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
treatment completion
Secondary outcome measures
Quality of life

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Medically-Tailored Hospital-Based Food Pantry (Pantry)Experimental Treatment2 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 Treatment2 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 Control2 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Focus groups
2017
N/A
~340
surveys
2006
N/A
~730

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,956 Previous Clinical Trials
594,888 Total Patients Enrolled
Lincoln Medical and Mental Health CenterOTHER
10 Previous Clinical Trials
1,464 Total Patients Enrolled
Montefiore Health SystemUNKNOWN

Media Library

Focus groups Clinical Trial Eligibility Overview. Trial Name: NCT01603316 — Phase 2
Cancer Research Study Groups: Home Grocery Delivery (Delivery), Food Voucher Program (Voucher), Medically-Tailored Hospital-Based Food Pantry (Pantry)
Cancer Clinical Trial 2023: Focus groups Highlights & Side Effects. Trial Name: NCT01603316 — Phase 2
Focus groups 2023 Treatment Timeline for Medical Study. Trial Name: NCT01603316 — Phase 2
~76 spots leftby May 2026
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