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NCT01603316 | RECRUITING | Cancer Patients

Food: A Three-Arm Study Examining Food Insecurity Interventions
Sponsor:

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 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, New York Cancer \& Blood Before Specialists, and Bellevue Hospital. 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.

Condition or disease

Cancer Patients

Intervention/treatment

surveys

Focus groups

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 668 participants
Masking : NONE
Primary Purpose : OTHER
Official Title : Food: A Three-Arm Randomized Controlled Study Examining Food Insecurity Interventions
Actual Study Start Date : 2012-05-08
Estimated Primary Completion Date : 2026-05
Estimated Study Completion Date : 2026-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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)
                • * Patient or family member has participated in other MSK IHCD trials related to social determinants of health
Food: A Three-Arm Study Examining Food Insecurity Interventions

Location Details

NCT01603316

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Locations

RECRUITING

United States, New York

St. Barnabas Medical Center

Bronx, New York, United States, 10457

RECRUITING

United States, New York

Jacobi Medical Center

Bronx, New York, United States, 10465

RECRUITING

United States, New York

Montefiore Health System (Montefiore Medical Center)

Bronx, New York, United States, 10467

RECRUITING

United States, New York

New York Cancer & Blood Specialists (Data collection only)

Bronx, New York, United States, 10469

RECRUITING

United States, New York

Lincoln Medical and Mental Health Center

Bronx, New York, United States,

ACTIVE NOT RECRUITING

United States, New York

Brooklyn Hospital Center

Brooklyn, New York, United States, 11201

ACTIVE NOT RECRUITING

United States, New York

Queens Hospital Center

Jamaica, New York, United States, 11432

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

RECRUITING

United States, New York

Bellevue Hospital Center

New York, New York, United States,

RECRUITING

United States, New York

Ralph Lauren Center for Cancer Care and Prevention

New York, New York, United States,