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

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

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

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

Food pantry referrals

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

No-prep, ready-to-eat meals

A $75 voucher is provided each month and participants are instructed to use the voucher to purchase food or transportation to food retailers.

Vouchers

Carolyn Haskins, MS

Jessica Turcios, BS

Jessica ‪ Turcios, BS

Kelseanna Hollis-Hansen, PhD, MPH

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.

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.

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.

It is not possible to mask staff or participants in this trial.

Screening for and Responding to Food Insecurity Among Infusion Patients

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

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.

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.

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.

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).

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.

University of Texas Southwestern Medical Center

Assistant Professor

* Referral to services
* Nutrition pamphlets
* One-time payment of $300 paid 4 months after baseline

* Three monthly payments of $100
* Referral to services
* Nutrition pamphlets

The UCT consists of three $100 VISA merchandise cards provided monthly via mail to participants randomized to the intervention arm. Merchandise cards can be used anywhere that VISA is accepted. Participants in the UCT arm will also receive Usual Care, including referral to the patient support services team and nutritional pamphlets.

Unconditional Cash Transfer (UCT)

Jean A McDougall, PhD, MPH

This trial will examine the feasibility and preliminary effectiveness of providing unconditional cash transfers to food insecure female breast and gynecologic cancer patients.

Approximately one-third of cancer survivors report food insecurity, characterized by limited access to adequate food for active, healthy living because of a lack of money and other resources. Unconditional cash transfers offer direct monetary assistance that can be used to meet immediate food or other financial needs and may positively impact health care resource utilization and health-related quality of life.

In this delayed intervention trial, 44 female breast and gynecologic cancer patients experiencing food insecurity will be randomized in a 1:1 ratio to receive unconditional cash transfers (UCT) for 3 months or an equivalent one-time UCT at the end of the study.

Quantitative surveys will be administered at baseline and after 3-months. Survey measures will include questions about health care resource utilization, health-related quality of life, food security, hospitalization use, emergency department use, and mental health. The main objective for this pilot trial is to assess feasibility. The investigators will measure whether the investigators can: recruit 44 food insecure participants meeting the eligibility criteria over a 3-month recruitment window and describe the barriers and facilitators of the recruitment process. The investigators will also monitor retention and survey completion. At the end of the 3 month follow-up period, all participants will complete a semi-structured exit interview.

This is a randomized pilot trial. Eligible individuals will be identified from breast and gynecologic clinics in the New Mexico Cancer Care Alliance. Participants will be screened for food insecurity and asked to complete a baseline survey. Participants will then be randomized to either Usual Care or to the UCT intervention. All participants will complete a 3-month follow-up, survey and a qualitative exit interview.

No blinding will be used in this pilot trial.

Food Insecurity in Oncology

Food Insecurity in Oncology (FIOnc)

Nine of the Global Health PROMIS measures items are scored on a Likert scale, with 1 representing the worst health situation and 5 representing the best health situation. Pain is scored from 0 to 10 with 0 indicating no pain and 10 representing the worst pain ever experienced. Two sub-scores can also be derived from the 10 item questionnaire to assess physical and mental health separately. Raw scores must be converted to a standardized T-score for interpretation. A higher PROMIS T-score indicates a person whose health is better than the average respondent.

The 4 questions that comprise this measure are measured on a Likert scale with 1 representing that the respondent is "not at all confident" completing the described task and 5 representing that the respondent is "very confident" completing the task. Raw scores range from 4-20, but T-score conversions are needed for interpretation. A higher PROMIS T-score indicates a person whose health is better than the average respondent.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Screening for and Responding to Food Insecurity Among Infusion Patients	NCT05889780	Cancer Diet, Healthy Nutrition, Heal...	Food pantry ref... No-prep, ready-... Vouchers	18 Years -	University of Texas Southwestern Medical Center
Food Insecurity in Oncology	NCT05176743	Food Insecurity Cancer	Unconditional C...	18 Years -	New Mexico Cancer Care Alliance
Screening for and Responding to Food Insecurity Among Infusion Patients	NCT05889780	Cancer Diet, Healthy Nutrition, Heal...	Food pantry ref... No-prep, ready-... Vouchers	18 Years -	University of Texas Southwestern Medical Center
Food Insecurity in Oncology	NCT05176743	Food Insecurity Cancer	Unconditional C...	18 Years -	New Mexico Cancer Care Alliance

Spots Global Cancer Trial Database for food insecurity