Viewing Study NCT05889780



Ignite Creation Date: 2024-05-06 @ 7:04 PM
Last Modification Date: 2024-10-26 @ 3:00 PM
Study NCT ID: NCT05889780
Status: RECRUITING
Last Update Posted: 2024-01-24
First Post: 2023-05-18

Brief Title: Screening for and Responding to Food Insecurity Among Infusion Patients
Sponsor: University of Texas Southwestern Medical Center
Organization: University of Texas Southwestern Medical Center

Study Overview

Official Title: Screening for and Responding to Food Insecurity Among Simmons Infusion Patients at RedBird
Status: RECRUITING
Status Verified Date: 2024-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 eg 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None