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Food: A Three-Arm Study Examining Food Insecurity Interventions

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 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: September 11, 2014
Last verified: September 2014

May 16, 2012
September 11, 2014
May 2012
May 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01603316 on ClinicalTrials.gov Archive Site
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).
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Cancer Patients
  • 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
  • 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

  • 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
  • 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.
    Intervention: Behavioral: Food pantry only arm
  • 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.
    Intervention: Behavioral: Food pantry + Food voucher arm
  • 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.
    Intervention: Behavioral: Food pantry + Grocery delivery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
May 2015
May 2015   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact: Francesca Gany, MD, MS 646-888-4240
Contact: Jennifer Leng, MD, MPH 646-888-4243
United States
 
NCT01603316
12-099
Not Provided
Memorial Sloan-Kettering Cancer Center
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
Principal Investigator: Francesca Gany, MD, MS Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
September 2014

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