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Food: A Three-Arm Study Examining Food Insecurity Interventions

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ClinicalTrials.gov Identifier: NCT01603316
Recruitment Status : Recruiting
First Posted : May 22, 2012
Last Update Posted : October 18, 2018
Sponsor:
Collaborators:
Queens Cancer Center of Queens Hospital
The Brooklyn Hospital Center
Lincoln Medical and Mental Health Center
Ralph Lauren Center for Cancer Care and Prevention
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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 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.


Condition or disease Intervention/treatment Phase
Cancer Patients Behavioral: surveys Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Food: A Three-Arm Randomized Controlled Study Examining Food Insecurity Interventions
Actual Study Start Date : May 8, 2012
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Arm Intervention/treatment
Active Comparator: Food Voucher Program (Voucher)
In the 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 and given to the patient. Patients will be instructed to use these cards only for food purchases. 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 voucher. Patients will be provided with a receipt holder to assist in storing receipts for review.
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

Experimental: Home Grocery Delivery (Delivery)
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.
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

Experimental: Medically-Tailored Hospital-Based Food Pantry (Pantry)
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 schedule a food pick-up appointment weekly at the hospital, either during one of their medical appointments or at another preferred, pre-arranged time. They will be given pre-packaged food bags, tailored when possible to their medical needs and cultural preferences.
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




Primary Outcome Measures :
  1. treatment completion [ Time Frame: 2 years ]
    Completion 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 Outcome Measures :
  1. Quality of life [ Time Frame: 2 years ]
    The 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patient is eligible if he/she is:

  • 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
  • Breast cancer diagnosis, Stage 1, 2, or 3* (soley for patients enrolled at Montefiore Medical Center, St Barnabas, 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

Focus Groups Inclusion Criteria:

  • Breast cancer patient, Stage 1,2, or 3,
  • Currently undergoing treatment with chemotherapy and/or radiation;
  • Food insecure: 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

Exclusion Criteria:

Patient is ineligible is he/she is:

  • 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, as detected during the ICCAN intake process.
  • Can not speak English or Spanish.
  • 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 RCT only

Focus Groups Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01603316


Contacts
Contact: Francesca Gany, MD, MS 646-888-8054
Contact: Jennifer Leng, MD, MPH 646-888-4243

Locations
United States, New York
St. Barnabas Hospital Not yet recruiting
Bronx, New York, United States, 10457
Contact: Theresa Barona, RN    718-960-9000      
Montefiore Medical Center Not yet recruiting
Bronx, New York, United States, 10461
Contact: Joseph Saprano, MM    718-405-8505      
Jacobi Medical Center Not yet recruiting
Bronx, New York, United States, 10465
Contact: Tarek Elrafei, D.O.    718-918-4581      
Lincoln Hospital Active, not recruiting
Bronx, New York, United States
Brooklyn Hospital Center Recruiting
Brooklyn, New York, United States, 11201
Contact: Elizabeth Guevera, MD         
Principal Investigator: Elizabeth Guevera, MD         
Queens Hospital Center Active, not recruiting
Jamaica, New York, United States, 11432
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Francesca Gany, MD, MS    646-888-8054      
Contact: Jennifer Leng, MD, MPH    646-888-4243      
Principal Investigator: Francesca Gany, MD, MS         
Ralph Lauren Center for Cancer Care and Prevention Recruiting
New York, New York, United States, 10035
Contact: Joseph Yoe, MD    212-987-1777 ext 5366      
Principal Investigator: Joseph Yoe, MD         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Queens Cancer Center of Queens Hospital
The Brooklyn Hospital Center
Lincoln Medical and Mental Health Center
Ralph Lauren Center for Cancer Care and Prevention
Investigators
Principal Investigator: Francesca Gany, MD, MS Memorial Sloan Kettering Cancer Center

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01603316     History of Changes
Other Study ID Numbers: 12-099
First Posted: May 22, 2012    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018

Keywords provided by Memorial Sloan Kettering Cancer Center:
Food pantry
Food voucher
Grocery delivery
12-099