Food: A Three-Arm Study Examining Food Insecurity Interventions

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborators:
Queens Cancer Center of Queens Hospital
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
ClinicalTrials.gov Identifier:
NCT01603316
First received: May 16, 2012
Last updated: March 11, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Cancer Patients
Behavioral: Food pantry only arm
Behavioral: Food pantry + Food voucher arm
Behavioral: Food pantry + Grocery delivery
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Food: A Three-Arm Randomized Controlled Study Examining Food Insecurity Interventions

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • treatment completion [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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:
  • Quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 120
Study Start Date: May 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Food pantry only arm
This is a three-arm randomized controlled trial comparing the impact of Food Vouchers, Grocery Home Delivery, and Hospital-based Food Pantries (Control) on cancer treatment completion, quality of life, food security, and nutritional status among immigrant and minority cancer patients with food insecurity.
Behavioral: Food pantry only arm
Participants will have: 1x per week access to food pantry. 3 and 6 month follow-up Administer study follow-up, Survey, Medical Chart review/extraction, Measure & record patient weight
Experimental: Food pantry + Food voucher arm
This is a three-arm randomized controlled trial comparing the impact of Food Vouchers, Grocery Home Delivery, and Hospital-based Food Pantries (Control) on cancer treatment completion, quality of life, food security, and nutritional status among immigrant and minority cancer patients with food insecurity.
Behavioral: Food pantry + Food voucher arm

Participants will have: 1x per week access to food pantry + 1x per month voucher to buy food *monthly voucher will be $230 *food receipts collected each month 3 and 6 month follow-up, Administer study follow-up Survey,

, Medical Chart review/extraction, Measure & record patient weight

Experimental: Food pantry + Grocery delivery
This is a three-arm randomized controlled trial comparing the impact of Food Vouchers, Grocery Home Delivery, and Hospital-based Food Pantries (Control) on cancer treatment completion, quality of life, food security, and nutritional status among immigrant and minority cancer patients with food insecurity.
Behavioral: Food pantry + Grocery delivery
Participants will have: 1x per week access to food pantry + 1x per week grocery delivery *weekly grocery delivery will include: 5 lunches & 5 dinners 3 and 6 month follow-up , Administer study follow-up Survey, Medical Chart review/extraction , Measure & record patient weight

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Enrolled in ICCAN
  • Within two weeks (+/- 2 weeks) of starting chemotherapy or 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 5 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

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, as detected during the ICCAN intake process.
  • Can not speak English, Mandarin 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01603316

Contacts
Contact: Francesca Gany, MD, MS 646-888-4240
Contact: Jennifer Leng, MD, MPH 646-888-4243

Locations
United States, New York
Lincoln Hospital Recruiting
Bronx, New York, United States
Contact: Niyati Bhagwati, MD    718-579-5000      
Brooklyn Hospital Center Not yet recruiting
Brooklyn, New York, United States, 11201
Contact: Elizabeth Guevera, MD         
Principal Investigator: Elizabeth Guevera, MD         
Queens Hospital Center Recruiting
Jamaica, New York, United States, 11432
Contact: Margaret Kemeny, MD         
Principal Investigator: Margaret Kemeny, MD         
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Francesca Gany, MD, MS    646-888-4240      
Contact: Jennifer Leng, MD, MPH    646-888-4243      
Principal Investigator: Francesca Gany, MD, MS         
Ralph Lauren Center for Cancer Care and Prevention Not yet 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
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
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01603316     History of Changes
Other Study ID Numbers: 12-099
Study First Received: May 16, 2012
Last Updated: March 11, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 18, 2014