Food: A Three-Arm Study Examining Food Insecurity Interventions

Status:	Recruiting
Conditions:	Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	3/15/2019
Start Date:	May 8, 2012
End Date:	May 2020
Contact:	Francesca Gany, MD, MS
Phone:	646-888-8054

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

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 four Bronx hospitals- North Central Bronx
Hospital (NCB), Jacobi Medical Center, St. Barnabas Hospital, and Montefiore Medical Center.
Before conducting the RCT across the 4 new sites in the Bronx.

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) in NYC

- 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 cancer diagnosis, Stage 1, 2, or 3* (soley for patients enrolled at Montefiore
Health System, St Barnabas Medical Center, Jacobi Medical Center, and North Central
Bronx)

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

Exclusion Criteria:

Focus Groups Exclusion Criteria:

- Has a household member who has already participated (or agreed to participate)

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)

We found this trial at

sites

Ralph Lauren Center for Cancer Care and Prevention

New York, New York 10035

Principal Investigator: Joseph Yoe, MD

Phone: 212-987-1777

from

New York, NY