Examining food assistance options for cancer patients facing food insecurity
Food: A Three-Arm Randomized Controlled Study Examining Food Insecurity Interventions
This study tests which type of food assistance—like a food pantry, monthly vouchers, or grocery delivery—helps cancer patients who struggle to get enough food during their treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 668 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 10 sites (Bronx, New York and 9 other locations) |
| Trial ID | NCT01603316 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of different food assistance interventions on cancer patients experiencing food insecurity. Participants will be randomly assigned to one of three groups: a hospital-based food pantry, a monthly food voucher program, or a weekly grocery delivery service. The goal is to determine which intervention best supports patients in maintaining their nutrition during cancer treatment, thereby improving their ability to complete treatment. The study will utilize surveys and focus groups to gather data on patient experiences and outcomes.
Who should consider this trial
Good fit: Ideal candidates are breast cancer patients in stages 1, 2, or 3, currently undergoing chemotherapy or radiation, and experiencing low food security.
Not a fit: Patients who are not experiencing food insecurity or those in assisted living facilities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the nutritional status and treatment adherence of cancer patients facing food insecurity.
How similar studies have performed: Other studies have shown promising results in addressing food insecurity among vulnerable populations, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bronx, New York and 9 other locations
- St. Barnabas Medical Center — Bronx, New York, United States (Recruiting)
- Jacobi Medical Center — Bronx, New York, United States (Recruiting)
- Montefiore Health System (Montefiore Medical Center) — Bronx, New York, United States (Recruiting)
- New York Cancer & Blood Specialists (Data collection only) — Bronx, New York, United States (Recruiting)
- Lincoln Medical and Mental Health Center — Bronx, New York, United States (Recruiting)
- Brooklyn Hospital Center — Brooklyn, New York, United States (Active_not_recruiting)
- Queens Hospital Center — Jamaica, New York, United States (Active_not_recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- Bellevue Hospital Center — New York, New York, United States (Recruiting)
- Ralph Lauren Center for Cancer Care and Prevention — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Francesca Gany, MD, MS — Memorial Sloan Kettering Cancer Center
- Study coordinator: Francesca Gany, MD, MS
- Phone: 646-888-8054
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.