Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Food: A Three-Arm Study Examining Food Insecurity Interventions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01603316
Recruitment Status : Recruiting
First Posted : May 22, 2012
Last Update Posted : June 23, 2021
Sponsor:
Collaborators:
Queens Cancer Center of Queens Hospital
The Brooklyn Hospital Center
Lincoln Medical and Mental Health Center
Jacobi Medical Center
St. Barnabas Medical Center
Montefiore Health System
Columbia University
Roswell Park Cancer Institute
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 three Bronx hospitals- Jacobi Medical Center, St. Barnabas Hospital, and Montefiore Medical Center. For the new study arms, we will enroll patients across Lincoln Medical and Mental Health Center, Jacobi Medical Center, St. Barnabas Medical Center, and Montefiore Health System. Before conducting the RCT across Lincoln Medical and Mental Health Center and the three new sites in the Bronx, we will refine written educational materials to be used in the intervention through focus groups.


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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 668 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 2023
Estimated Study Completion Date : May 2023

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 in person or via mail. 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 vouche, or by providing electronic copies of receipts. Patients will be provided with a receipt holder to assist in storing receipts for review. For voucher cards sent via mail, patients will receive a mailing letter accompanying each card.
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. All participants will be asked to complete the study contact form. Need Assessment surveys will be administered via telephone or in person. The content of the needs assessment questionnaire has been informed by themes generated through IHCD's ongoing research and community outreach and service activities with the cancer patient population at our participating institutions. The survey will ask participants about the impact on their cancer care and their socioeconomic needs of the COVID-19 crisis.

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, via mail, MSK Secure email, or in person and nutrition education sessions.

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. All participants will be asked to complete the study contact form. Need Assessment surveys will be administered via telephone or in person. The content of the needs assessment questionnaire has been informed by themes generated through IHCD's ongoing research and community outreach and service activities with the cancer patient population at our participating institutions. The survey will ask participants about the impact on their cancer care and their socioeconomic needs of the COVID-19 crisis.

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, via mail, MSK Secure email, or in person and nutrition education sessions.

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 pick-up a pantry bag weekly or bi-weekly (per patient preference) at the hospital, either during one of their medical appointments or at another preferred time. Each patient's food prefereces will be assessed once during baseline and they will be given food bags, tailored when possible and when available to these preferences and 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. All participants will be asked to complete the study contact form. Need Assessment surveys will be administered via telephone or in person. The content of the needs assessment questionnaire has been informed by themes generated through IHCD's ongoing research and community outreach and service activities with the cancer patient population at our participating institutions. The survey will ask participants about the impact on their cancer care and their socioeconomic needs of the COVID-19 crisis.

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, via mail, MSK Secure email, or in person and nutrition education sessions.




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).



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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)
  • 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 or gynecologic cancer diagnosis, Stage 1, 2, or 3 (for the updated arms only: 1) Food Voucher Program (Voucher); 2) Home Grocery Delivery Program (Delivery); and 3) Medically-tailored, Hospital-based Food Pantry (Pantry)

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

Secondary Aim 6 Needs Assessment eligibility criteria:

  • Current or past breast cancer diagnosis
  • 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, or Spanish

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)

Secondary Aim 6 Needs Assessment Exclusion criteria:

  • Significant psychiatric disturbance verified by medical record enough 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) enough to preclude meaningful informed consent and/or data collection
  • Cannot speak English or Spanish
  • Has physical limitations that would prevent participation (e.g. blindness)

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
Layout table for location contacts
Contact: Francesca Gany, MD, MS 646-888-8054
Contact: Jennifer Leng, MD, MPH 646-888-4243

Locations
Layout table for location information
United States, New York
St. Barnabas Medical Center Not yet recruiting
Bronx, New York, United States, 10457
Contact: Ilmana Fulger, MD    718-960-3730      
Jacobi Medical Center Recruiting
Bronx, New York, United States, 10465
Contact: Tarek Elrafei, D.O.    718-918-4581      
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Della Makower, MD    718-862-8840      
Lincoln Medical and Mental Health Center Recruiting
Bronx, New York, United States
Contact: Caroline Hwang, MD    718-579-5000      
Brooklyn Hospital Center Active, not recruiting
Brooklyn, New York, United States, 11201
Queens Hospital Center Active, not recruiting
Jamaica, New York, United States, 11432
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
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
Contact: Francesca Gany, MD, PhD    646-888-8054      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Queens Cancer Center of Queens Hospital
The Brooklyn Hospital Center
Lincoln Medical and Mental Health Center
Jacobi Medical Center
St. Barnabas Medical Center
Montefiore Health System
Columbia University
Roswell Park Cancer Institute
Investigators
Layout table for investigator information
Principal Investigator: Francesca Gany, MD, MS Memorial Sloan Kettering Cancer Center
Additional Information:
Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01603316    
Other Study ID Numbers: 12-099
First Posted: May 22, 2012    Key Record Dates
Last Update Posted: June 23, 2021
Last Verified: June 2021
Keywords provided by Memorial Sloan Kettering Cancer Center:
Food pantry
Food voucher
Grocery delivery
12-099