Screening for and Responding to Food Insecurity Among Infusion Patients

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05889780
• Other study ID #: 48557
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: University of Texas Southwestern Medical Center
• Contact: Carolyn Haskins, MS
• Phone: ?(469) 431-3992?
• Email: carolyn.haskins[@]utsouthwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cancer
• Diet, Healthy

Intervention

Other:
• Food pantry referrals
Clients receive food for up to 21 meals per person in the household each month.
• No-prep, ready-to-eat meals
12 nutritious no-prep, ready-to-eat meals are provided each month.
• Vouchers
A $75 voucher is provided each month and participants are instructed to use the voucher to purchase food or transportation to food retailers.

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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).	3-months
Secondary	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