Food: A Three-Arm Study Examining Food Insecurity Interventions
This study is currently recruiting participants.
Verified May 2013 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Memorial Sloan-Kettering Cancer Center
Collaborators:
Queens Cancer Center of Queens Hospital
Brooklyn Hospital Center
Lincoln Hospital 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: May 17, 2013
Last verified: May 2013
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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 2014 |
| Estimated Primary Completion Date: | May 2014 (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
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 | Not yet 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: Gina Volani, MD 718-250-8000 | |
| Principal Investigator: Gina Volani, 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: Gina P. Villani, MD | |
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Queens Cancer Center of Queens Hospital
Brooklyn Hospital Center
Lincoln Hospital 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: | May 17, 2013 |
| 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 June 18, 2013