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Trial Title:
Screening for and Responding to Food Insecurity Among Infusion Patients
NCT ID:
NCT05889780
Condition:
Cancer
Diet, Healthy
Nutrition, Healthy
Conditions: Keywords:
Food insecurity
Food pantry
Nutrition intervention
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Factorial Assignment
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
Masking:
None (Open Label)
Masking description:
It is not possible to mask staff or participants in this trial.
Intervention:
Intervention type:
Other
Intervention name:
Food pantry referrals
Description:
Clients receive food for up to 21 meals per person in the household each month.
Arm group label:
Nutritious, no-prep meals
Arm group label:
Pantry only
Arm group label:
Vouchers
Intervention type:
Other
Intervention name:
No-prep, ready-to-eat meals
Description:
12 nutritious no-prep, ready-to-eat meals are provided each month.
Arm group label:
Nutritious, no-prep meals
Intervention type:
Other
Intervention name:
Vouchers
Description:
A $75 voucher is provided each month and participants are instructed to use the voucher
to purchase food or transportation to food retailers.
Arm group label:
Vouchers
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.
Criteria for 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).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UT Southwestern Medical Center
Address:
City:
Dallas
Zip:
75390
Country:
United States
Status:
Recruiting
Contact:
Last name:
Carolyn Haskins, MS
Email:
carolyn.haskins@utsouthwestern.edu
Contact backup:
Last name:
Jessica Turcios, BS
Email:
jessica.turcios@utsouthwestern.edu
Investigator:
Last name:
Kelseanna Hollis-Hansen, PhD, MPH
Email:
Principal Investigator
Start date:
January 8, 2024
Completion date:
December 31, 2024
Lead sponsor:
Agency:
University of Texas Southwestern Medical Center
Agency class:
Other
Source:
University of Texas Southwestern Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05889780
