Screening for and Responding to Food Insecurity Among Infusion Patients
NCT ID: NCT05889780
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
45 participants
INTERVENTIONAL
2024-01-08
2024-09-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Pantry only
Referrals to onsite food pantry or emergency food boxes from partner pantry if onsite pantry is not open by 2024.
Food pantry referrals
Clients receive food for up to 21 meals per person in the household each month.
Nutritious, no-prep meals
Participants will receive up to 12 nutritious no-prep meals per month (three meals per week) for three-months.
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
Participants will receive $75 vouchers each month for three-months.
Food pantry referrals
Clients receive food for up to 21 meals per person in the household 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Texas Southwestern Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Kelseanna Hollis-Hansen
Assistant Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kelseanna Hollis-Hansen, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UT Southwestern Medical Center
Dallas, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
48557
Identifier Type: -
Identifier Source: org_study_id