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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 : December 6, 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
North Central Bronx
Jacobi Medical Center
St. Barnabas Medical Center
Montefiore Health System
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

May 16, 2012
May 22, 2012
December 6, 2018
May 8, 2012
May 2019   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01603316 on ClinicalTrials.gov Archive Site
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).
Same as current
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Food: A Three-Arm Study Examining Food Insecurity Interventions
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.

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Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Cancer Patients
  • 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
  • Behavioral: Focus 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 and nutrition education sessions.
  • 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.
    Interventions:
    • Behavioral: surveys
    • Behavioral: Focus groups
  • 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.
    Interventions:
    • Behavioral: surveys
    • Behavioral: Focus groups
  • 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.
    Interventions:
    • Behavioral: surveys
    • Behavioral: Focus groups
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
120
May 2019
May 2019   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Francesca Gany, MD, MS 646-888-8054
Contact: Jennifer Leng, MD, MPH 646-888-4243
United States
 
 
NCT01603316
12-099
Not Provided
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Memorial Sloan Kettering Cancer Center
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
  • North Central Bronx
  • Jacobi Medical Center
  • St. Barnabas Medical Center
  • Montefiore Health System
Principal Investigator: Francesca Gany, MD, MS Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP