Screening for and Responding to Food Insecurity Among Infusion Patients

Study Overview
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Brief Summary
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Food insecurity impacts 1 in 8 people in the United States and 1 in 4 people receiving cancer treatment. Food insecurity is associated with poor dietary quality, adverse health conditions (e.g., Type 2 diabetes, overweight and obesity, hypertension), and worse cancer treatment outcomes. To effectively address food insecurity among people with cancer, screening and effective response programs are needed. The Food to Overcome Disparities (FOOD) program screens breast cancer patients for food insecurity and refers people who screen positive to 11 clinic pantries across New York City. In addition to clinic referrals, researchers have found the addition of monthly grocery vouchers or home grocery delivery to be even more effective at improving treatment completion rates than pantry access alone. Another innovative food security strategy, nutritious no-prep, ready-to-eat meals may also be helpful for patients given that no-prep meals reduce the time and physical demand of food preparation. Nutritious no-prep, ready-to-eat meals have been positively associated with improvements in healthy eating index (HEI) scores, fewer instances of hypoglycemia, and improved quality of life among people with food insecurity that have diabetes, but has yet to be tested among patients with cancer. People receiving cancer treatment, such as infusion services, often report fatigue and other barriers to food preparation, which make no-prep, ready-to-eat meals another potential solution to cancer-specific challenges to healthy eating. In the present study the investigators will test which evidence-based strategies are most effective and well-liked by patients and will inform the development of a comprehensive food security response program at the Harold C. Simmons Comprehensive Cancer Center.

Detailed Description
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In the proposed study, the study team will screen infusion patients for food insecurity and refer those who screen positive to enroll in a randomized controlled trial where participants will receive one of three evidence-based food security programs: 1) Pantry only - Referrals to onsite food pantry or emergency food boxes if the onsite pantry is not open by 2024, 2) Pantry plus nutritious no-prep, ready-to-eat meals, or 3) Pantry plus $75 grocery vouchers for three-months. The study team will assess improvements in patient food security, diet quality, satisfaction, and wellbeing over time. Results of this pilot will inform the design of a food security response program for patients.

Official Title
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Screening for and Responding to Food Insecurity Among Simmons Infusion Patients at RedBird

Conditions
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Cancer, Diet, Healthy, Nutrition, Healthy

Intervention / Treatment
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* Other: Food pantry referrals
* Other: No-prep, ready-to-eat meals
* Other: Vouchers


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient at the Simmons cancer center Adults 18 years or older Ability to understand and willingness to provide informed consent Screens positive for food and/or nutrition insecurity No allergies or digestive diseases that could put participant at-risk of harm from consuming study foods (e.g., celiacs disease, dairy allergy, wheat allergy) Exclusion Criteria: Not a patient at the Simmons cancer center Under 18 years of age Unable to provide informed consent Not wanting to participate Does not screen positive for food and/or nutrition insecurity Allergies or digestive diseases that could put participants at-risk of harm from consuming study foods (e.g., celiacs disease, dairy allergy, wheat allergy).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: In the proposed study, infusion patients that screen positve for food insecurity that enroll in the study will be randomized to receive one of three evidence-based food security programs: 1) Pantry only - Referrals to an onsite food pantry or receipt of emergency food boxes if the onsite pantry is not open by 2024, 2) Pantry + nutritious no-prep, ready-to-eat meals, or 3) Pantry + $75 grocery vouchers for three-months.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pantry only<br>Referrals to onsite food pantry or emergency food boxes from partner pantry if onsite pantry is not open by 2024. | Other: Food pantry referrals<br>* Clients receive food for up to 21 meals per person in the household each month.<br>|
| Experimental: Nutritious, no-prep meals<br>Participants will receive up to 12 nutritious no-prep meals per month (three meals per week) for three-months. | Other: Food pantry referrals<br>* Clients receive food for up to 21 meals per person in the household each month.<br>Other: No-prep, ready-to-eat meals<br>* 12 nutritious no-prep, ready-to-eat meals are provided each month.<br>|
| Experimental: Vouchers<br>Participants will receive $75 vouchers each month for three-months. | Other: Food pantry referrals<br>* Clients receive food for up to 21 meals per person in the household each month.<br>Other: Vouchers<br>* A $75 voucher is provided each month and participants are instructed to use the voucher to purchase food or transportation to food retailers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food security | 6-item United States Department of Agriculture Food Security Screener (USDA); questionnaire; raw score 0-1-High or marginal food security, 2-4-Low food security, 5-6-Very low food security. | 3-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | Satisfaction with clinical experience and interventions; two-items from the HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) Survey will be used to measure patient satisfaction with the clinical experience - items 21 & 22 on Overall Rating of Hospital (Q21) and Willingness to Recommend Hospital (Q22) - minimum = 0 (poorer quality care), maximum = 4 (higher quality care). | 3-months | 
| Patient wellbeing | The World Health Organisation-Five Well-Being Index (WHO-5), 5-items with 5 response options each, 0 to 25, 0 respresents worst possible quality of life and 25 represents best possible quality of life. | 3-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Food insecurity, Food pantry, Nutrition intervention