Clinical trial NCT01603316: Food: A Three-Arm Study Examining Food Insecurity Interventions
Official title: Food: A Three-Arm Randomized Controlled Study Examining Food Insecurity Interventions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Cancer Patients
Keywords: Food pantry
Food voucher
Grocery delivery
12-099
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Queens Cancer Center of Queens Hospital
name: The Brooklyn Hospital Center
name: Lincoln Medical and Mental Health Center
name: Jacobi Medical Center
name: St. Barnabas Medical Center
name: Montefiore Health System
name: Columbia University
name: Roswell Park Cancer Institute
name: NYU Langone Health
First posted: 2012-05-22
Enrollment: 668
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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 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)

Secondary Aim 6 Needs Assessment Exclusion criteria:

* Significant psychiatric disturbance verified by medical record enough 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) enough to preclude meaningful informed consent and/or data collection
* Cannot speak English or Spanish
* Has physical limitations that would prevent participation (e.g. blindness)
* Patient or family member has participated in other MSK IHCD trials related to social determinants of health

Primary outcomes:
measure: treatment completion
timeFrame: 2 years
Secondary outcomes:
measure: Quality of life
timeFrame: 2 years
Other outcomes:
Locations:
city: Bronx
country: United States
facility: St. Barnabas Medical Center
state: New York
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
city: Bronx
country: United States
facility: Montefiore Health System (Montefiore Medical Center)
state: New York
city: Bronx
country: United States
facility: New York Cancer & Blood Specialists (Data collection only)
state: New York
city: Bronx
country: United States
facility: Lincoln Medical and Mental Health Center
state: New York
city: Brooklyn
country: United States
facility: Brooklyn Hospital Center
state: New York
city: Jamaica
country: United States
facility: Queens Hospital Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Bellevue Hospital Center
state: New York
city: New York
country: United States
facility: Ralph Lauren Center for Cancer Care and Prevention
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Francesca Gany, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gany F, Melnic I, Wu M, Li Y, Finik J, Ramirez J, Blinder V, Kemeny M, Guevara E, Hwang C, Leng J. Food to Overcome Outcomes Disparities: A Randomized Controlled Trial of Food Insecurity Interventions to Improve Cancer Outcomes. J Clin Oncol. 2022 Nov 1;40(31):3603-3612. doi: 10.1200/JCO.21.02400. Epub 2022 Jun 16.