Clinical trial NCT05889780: Screening for and Responding to Food Insecurity Among Infusion Patients
Official title: Screening for and Responding to Food Insecurity Among Simmons Infusion Patients at RedBird
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Diet, Healthy
Nutrition, Healthy
Keywords: Food insecurity
Food pantry
Nutrition intervention
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Food security
timeFrame: 3-months
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 3-months
measure: Patient wellbeing
timeFrame: 3-months
Other outcomes:
measure: Diet quality
timeFrame: 3-months
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Kelseanna Hollis-Hansen, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.