Screening for and Responding to Food Insecurity Among Infusion Patients

December 5, 2024 updated by: Kelseanna Hollis-Hansen, University of Texas Southwestern Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Food security
Time Frame: 3-months
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
Time Frame: 3-months
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
Time Frame: 3-months
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diet quality
Time Frame: 3-months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: Kelseanna Hollis-Hansen, PhD, MPH, UT Southwestern Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2024

Primary Completion (Actual)

September 6, 2024

Study Completion (Actual)

September 6, 2024

Study Registration Dates

First Submitted

May 18, 2023

First Submitted That Met QC Criteria

June 1, 2023

First Posted (Actual)

June 5, 2023

Study Record Updates

Last Update Posted (Estimated)

December 9, 2024

Last Update Submitted That Met QC Criteria

December 5, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 48557

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

12-months after article publication, up to 24-months.

IPD Sharing Access Criteria

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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