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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pantry only | Active Comparator | Referrals to onsite food pantry or emergency food boxes from partner pantry if onsite pantry is not open by 2024. |
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| Nutritious, no-prep meals | Experimental | Participants will receive up to 12 nutritious no-prep meals per month (three meals per week) for three-months. |
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| Vouchers | Experimental | Participants will receive $75 vouchers each month for three-months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Food pantry referrals | Other | Clients receive food for up to 21 meals per person in the household each month. |
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| 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 |
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Diet quality | Abbreviated Diet History Questionnaire III (DHQ-III) is a food frequency questionnaire (FFQ) that will be used to calculate a Healthy Eating Index score with a minimum value of 0 indicating poor dietary quality and a maximum value of 100 indicating high dietary quality. | 3-months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kelseanna Hollis-Hansen, PhD, MPH | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35709430 | Background | Gany F, Melnic I, Wu M, Li Y, Finik J, Ramirez J, Blinder V, Kemeny M, Guevara E, Hwang C, Leng J. Food to Overcome Outcomes Disparities: A Randomized Controlled Trial of Food Insecurity Interventions to Improve Cancer Outcomes. J Clin Oncol. 2022 Nov 1;40(31):3603-3612. doi: 10.1200/JCO.21.02400. Epub 2022 Jun 16. | |
| 30421335 | Background |
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Data requests can be submitted to the PI 12 months after article publication. The data can be made accessible for up to 24 months for those who have access to secure data storage.
12-months after article publication, up to 24-months.
Access to trial IPD can be requested by qualified researchers, and will be provided following review and approval of a research proposal that includes an analytic plan and a data sharing agreement. For more information or to submit a request, please contact the study team.
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D057140 | Fast Foods |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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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.
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It is not possible to mask staff or participants in this trial.
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| No-prep, ready-to-eat meals | Other | 12 nutritious no-prep, ready-to-eat meals are provided each month. |
|
| Vouchers | Other | A $75 voucher is provided each month and participants are instructed to use the voucher to purchase food or transportation to food retailers. |
|
| 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 |
| Berkowitz SA, Delahanty LM, Terranova J, Steiner B, Ruazol MP, Singh R, Shahid NN, Wexler DJ. Medically Tailored Meal Delivery for Diabetes Patients with Food Insecurity: a Randomized Cross-over Trial. J Gen Intern Med. 2019 Mar;34(3):396-404. doi: 10.1007/s11606-018-4716-z. Epub 2018 Nov 12. |