Screening for and Responding to Food Insecurity Among Infusion Patients

NCT05889780 | Completed

• 1 other identifier: 48557
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Diet, Healthy; Nutrition, Healthy

Keywords

Food insecurity; Food pantry; Nutrition intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Patient satisfaction

  3-months

• Patient wellbeing

  3-months

Other Outcomes (1)

• Diet quality

  3-months

Study Arms (3)

Pantry only

ACTIVE COMPARATOR

Referrals to onsite food pantry or emergency food boxes from partner pantry if onsite pantry is not open by 2024.

Other: Food pantry referrals

Nutritious, no-prep meals

EXPERIMENTAL

Participants will receive up to 12 nutritious no-prep meals per month (three meals per week) for three-months.

Other: Food pantry referrals; Other: No-prep, ready-to-eat meals

Vouchers

EXPERIMENTAL

Participants will receive $75 vouchers each month for three-months.

Other: Food pantry referrals; Other: Vouchers

Interventions

Food pantry referrals OTHER

Clients receive food for up to 21 meals per person in the household each month.

Nutritious, no-prep meals; Pantry only; Vouchers

No-prep, ready-to-eat meals OTHER

12 nutritious no-prep, ready-to-eat meals are provided each month.

Nutritious, no-prep meals

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.

Vouchers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (2)

• 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.

  PMID: 35709430 BACKGROUND

• 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.

  PMID: 30421335 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Interventions

Fast Foods

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Kelseanna Hollis-Hansen, PhD, MPH

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: It is not possible to mask staff or participants in this trial.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: June 5, 2023
• Study Start: January 8, 2024
• Primary Completion: September 6, 2024
• Study Completion: September 6, 2024
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 12-months after article publication, up to 24-months.
• 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.

Locations

US (1)