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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 : June 28, 2022
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

Tracking Information
First Submitted Date  ICMJE May 16, 2012
First Posted Date  ICMJE May 22, 2012
Last Update Posted Date June 28, 2022
Actual Study Start Date  ICMJE May 8, 2012
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2012)
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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Food: A Three-Arm Study Examining Food Insecurity Interventions
Official Title  ICMJE Food: A Three-Arm Randomized Controlled Study Examining Food Insecurity Interventions
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 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, Montefiore Health System, and New York Cancer & Blood Before Specialists. Before conducting the RCT across Lincoln Medical and Mental Health Center and the new sites in the Bronx, we will refine written educational materials to be used in the intervention through focus groups.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Cancer Patients
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Active Comparator: Food Voucher Program (Voucher)
    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 & given to the patient in person or via mail. Patients will be instructed to use these cards only for food purchases. If patients are not able to use the debit card at their local grocery stores, patients will be provided with a money order of the same dollar value instead of the debit card. 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.
    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 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.
    Interventions:
    • Behavioral: surveys
    • Behavioral: Focus groups
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 28, 2020)
668
Original Estimated Enrollment  ICMJE
 (submitted: May 18, 2012)
120
Estimated Study Completion Date  ICMJE May 2023
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
  • Patient or family member has participated in other MSK IHCD trials related to social determinants of health
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Francesca Gany, MD, MS 646-888-8054
Contact: Jennifer Leng, MD, MPH 646-888-4243
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01603316
Other Study ID Numbers  ICMJE 12-099
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Memorial Sloan Kettering Cancer Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Francesca Gany, MD, MS Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date June 2022

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