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

Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Inflammation

Breast Neoplasms

Body Weight

Mastitis

Weight Gain

Gestational Weight Gain

Breast Diseases

Skin Diseases

Body Weight Changes

Intensive dietary counseling and fruit and vegetable box delivery.

Control condition of information on healthy eating during breastfeeding

The counseling approach will employ strategies shown to be successful in previous and ongoing dietary modification studies including supportive and motivational interviewing techniques. Each woman in the diet intervention group will be assigned a trained nutrition coach/counselor. Counselors will focus on helping participants identify and address barriers to achieving the goal of consuming at least 8 to 10 servings of nutrient dense fruits and vegetables each day (e.g., modifying recipes and food preparation). Participants will also receive weekly boxes of fruits and vegetables .

Dietary Counseling

Kathleen Arcaro, PhD

Susan Sturgeon, DrPH

Lindiwe Sibeko, PhD

Mechanistic data show that compounds in fruits and vegetables have anti-inflammatory and anti-carcinogenic properties that can reduce breast cancer risk. However, observational and interventional studies have provided mixed results, and a recent report by the American Institute for Cancer Research (AICR) concludes that the data are insufficient but suggestive that non-starchy vegetables and foods containing carotenoids reduce risk. Measurement error, relatively low levels of carotenoid-rich fruit and vegetable intake in the study populations, emphasis on diet in later adulthood, and confounding factors likely contribute to the weak associations. Therefore, the investigators will conduct a randomized diet intervention trial in young women to assess the extent to which at least 8 to 10 daily servings of deeply pigmented and nutrient dense fruits and vegetables reduces biomarkers of breast cancer risk. The intervention is focused on breastfeeding women because: 1) pregnancy and lactation are normal early life course events; 2) the risk of pregnancy-associated breast cancer (PABC) is increased for up to 10 years postpartum; 3) a dietary intervention to reverse the detrimental molecular changes associated with puberty and pregnancy is more likely to be successful in younger than in older women;4) a diet rich in fruits and vegetables is hypothesized to reduce the inflammation during lactation/weaning and lower PABC risk; 5) postpartum lactating women may be a highly motivated population; and 6) breastmilk provides access to the breast microenvironment and breast epithelial cells to non-invasively assess the diet intervention directly in the breast. Four hundred nursing mothers will be randomly assigned to either the intervention arm, in which they are asked to increase fruit and vegetable intake to at least 8 to 10 daily servings for one year, or to a control condition in which participants receive a dietary guideline for breastfeeding mothers. Women in the intervention arm will receive counseling and boxes of fruits and vegetables for the first 20 weeks, after which they will continue to receive counseling. Changes in DNA methylation and cytokine profiles in breastmilk will be evaluated. Maternal weight and body fat distribution, and infant growth will be monitored. These results will greatly expand our knowledge of how diet alters molecular pathways in a specific organ, ultimately contributing to both breast cancer etiology and prevention.

Overview of home visits and activities completed by all participants

Visit 1 Introductory Visit (1.5 hours) 24-Hour Dietary Recalls completed during the week (1-2 hours) Occurs at 5 weeks postpartum

* Informed Consent document administered.
* Public Data Sharing Informed Consent document administered.
* Three questionnaires: New Moms Health, Physical Activity, and Breastfeeding Practices
* Maternal height, weight, and waist circumference measured.
* Instructions provided for future collection of biospecimens.
* Complete one 24-Hour Dietary Recall
* Instructions provided for two additional 24-Hour Dietary Recalls.

Visit 2 Sample Collection 1 (1.5 hours) Occurs at 6 weeks postpartum

* Provide bilateral breast milk samples and completed questionnaire.
* Provide infant stool sample and completed questionnaire.
* Two questionnaires: Infant Feeding, and Medication \& Supplement
* Infant length and weight measured.
* Maternal and infant skin carotenoids measured.
* Nutrition education provided.
* Optional collection of maternal stool sample and completed questionnaire.

Visit 3 Sample Collection 2 (1.5 hours) 24-Hour Dietary Recalls completed during the week (1-2 hours) Occurs at 16 weeks postpartum

* Provide bilateral breast milk samples and completed questionnaire.
* Provide infant stool sample and completed questionnaire.
* Three questionnaires: Physical Activity, Infant Feeding, and Medication \& Supplement
* Infant length and weight measured.
* Maternal weight and waist circumference measured.
* Maternal and infant skin carotenoids measured.

Visit 4 Sample Collection 3 (1.5 hours) 24-Hour Dietary Recalls completed during the week (1-2 hours) Occurs at 26 weeks postpartum

* Provide bilateral breast milk samples and completed questionnaire.
* Provide infant stool sample and completed questionnaire.
* Three questionnaires: Physical Activity, Infant Feeding, and Medication \& Supplement.
* Infant length and weight measured.
* Maternal weight and waist circumference measured.
* Maternal and infant skin carotenoids measured.
* Optional collection of maternal stool samples and completed questionnaire.

Visit 5 Sample Collection 4 (1.5 hours) 24-Hour Dietary Recalls completed during the week (1-2 hours) Occurs at 58 weeks postpartum

* Provide bilateral breast milk samples and completed questionnaire.
* Provide infant stool sample and completed questionnaire.
* Four questionnaires: Physical Activity, Infant Feeding, Medication and Supplement, and Breast Health
* Infant length and weight measured.
* Maternal weight and waist circumference measured.
* Maternal and infant skin carotenoids measured.
* Optional collection of maternal stool samples and completed questionnaire.

Annual Follow-up Visit (Maximum of 2) (1 hour) 24-Hour Dietary Recalls completed during the week (1-2 hours) Occurs at one-year intervals after Visit 5

* Three questionnaires: Physical Activity, Breast Health, Young Child Feeding
* Infant height and weight measured.
* Maternal weight and waist circumference measured.
* Maternal and infant skin carotenoids measured.

Monthly Inquiry (1 - 2 minutes) Occurs monthly until no longer breastfeeding

• Complete the Breast Feeding Update Questionnaire online via a survey sent through REDCap, or through a phone call.

Key laboratory analyses will conducted by laboratories blinded to intervention arm.

Fruit and Vegetable Intervention in Lactating Women to Reduce Breast Cancer Risk

Fruit and Vegetable Intervention in Lactating Women to Reduce Breast Cancer Risk: Effects on Breast Cell DNA Methylation, Breast Inflammation,and Weight

There is no plan to make IPD available to other researchers.

% methylation in 300,000 CpG sites in DNA from sloughed breast epithelial cells from milk

Adiponectin, CRP, IFN-y, IL1-beta, Leptin, IL-6, IL-8, TNF-alpha, b-FGF, FLT-1, PLGF, VegF-D

National Cancer Institute (NCI)

University of Massachusetts, Amherst

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Rare Diseases

Obesity

Ovarian Neoplasms

Uterine Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Uterine Diseases

Ovarian Cancer

Cancer survivor-Daughter dyads randomized to the With Love, Grandma ("Con Cariño, Abuelita") group will access a digital lifestyle program that includes 8 modules of didactic, behavioral, and family communication/parenting/grandparenting content from smartphones over the course of 10-12 weeks.

This group is intended to reflect typical services cancer survivors and family members receive from healthcare providers.

Cancer survivor-Daughter dyads will log in to a secured website to access intervention content over a period of 10-12 weeks. The intervention will be delivered primarily through smartphones and will include 8 modules with didactic content on healthy lifestyle behaviors for cancer prevention and control, family behavior change content for setting weekly goals and self-monitoring health behaviors, and family communication and positive parenting/grandparenting content, all of which were developed in accordance with participant feedback based on formative intervention development work. In addition, and to increase participant compliance/reduce attrition often observed in digital health interventions, human support ("supportive accountability") will be provided. Specifically, each family will be assigned a "coach" who will use video conferencing software to engage in weekly 15-30 minute sessions regarding the family's progress throughout the intervention period.

With Love, Grandma ("Con Cariño, Abuelita")

Vanina Pavia, MD

Sara M St. George, PhD

The purpose of this study is to assess the feasibility, acceptability, and preliminary effects of a digital (web and mobile-phone-based) program to improve lifestyle behaviors (physical activity, dietary intake) among Hispanic female cancer survivors and adult daughters.

With Love, Grandma ("Con Cariño, Abuelita") Pilot Study

Pilot Study of a Multigenerational Digital Lifestyle Intervention for Hispanic Female Cancer Survivors and Their Families

Calculated by percent of enrolled survivor-daughter dyads who completed post-intervention measures

Calculated as number of modules completed (of 8 total modules) by survivors and daughters

Participants will self-report walking and sitting time (hours and minutes per day) using three items from the IPAQ. Mean difference in total time spent walking and sitting will be calculated from these items. The result is not reported in scales. Higher scores indicate higher time spent walking and sitting in the last 7 days.

Responses range from 0 - greater than 24, with 0 indicating no activity and a higher score indicating more activities (no maximum score).

Participants will self-report dietary intake using the NCI All-Day Screener for fruit and vegetables and the percentage of energy from fat and fiber. Mean difference in cup equivalents of fruits and vegetables will be calculated using a scoring algorithm developed by the National Cancer Institute

The V Foundation for Cancer Research

University of Miami Sylvester Comprehensive Cancer Center

Assistant Professor of Public Health Sciences

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

All Drugs and Chemicals

Antioxidants

Individuals aged 18-65 years, who applied to Ankara City Hospital Oncology Hospital Medical Oncology Outpatient Clinic, newly diagnosed with colorectal cancer as a result of the necessary examinations, at least 3 weeks after the surgical procedure and without metastasis (except for Stage IV)

A healthy adult between the ages of 18-65 who has not been diagnosed with any malignant disease and consented to participate in the study.

Nutritional status of individuals will be evaluated with a 24-hour retrospective food consumption record and food consumption frequency questionnaire. After 8-12 hours of fasting, body composition analysis will be performed and within the scope of anthropometric measurements, body weight, height length, BMI measurements will be taken. Then, venous blood will be taken from the participants C-reactive protein (CRP), albumin and chemerin level will be analyzed.

Dietary İntake, Biochemical parameters, Antropometric measuruments

Semra Bakir Angay

Aylin Acikgoz Pinar

Aylin Acikgoz Pinar, PhD

Mehmet Ali Nahit Sendur, Prof

To investigate the relationship between serum chemerin levels of individuals with colorectal cancer and systematic inflammatory response parameters such as C-reactive protein(CRP) and albumin, and to investigate the relationship of these biomarkers with dietary inflammatory index, phytochemical, anthropometric measurements, and dietary inflammatory index, which is calculated with the data obtained from the 24-hour food consumption record and food consumption frequency questionnaire. The aim of this study is to examine the relationships between the index and dietary antioxidant capacity and to compare them with those of healthy individuals.

The research will be executed. with 52 adult individuals between the ages of 18-65 who applied to the Ankara City Hospital Oncology Hospital Medical Oncology outpatient clinic, newly diagnosed with colorectal cancer (except for Stage IV), and 52 healthy adult individuals without any chronic disease, matched for age, gender, and BMI. Individuals will be told about the study in detail and those who accept will be included in the study by signing an informed consent form. A data collection form containing health and demographic information will be applied to the participants; Then, after 8-12 hours of fasting, body composition analysis (body fat ratio, muscle ratio, visceral fat level, resting metabolic rate) will be performed with the Omron BF511, a body composition analysis scale that works with the bioelectrical impedance method, and within the scope of anthropometric measurements, body weight, height length, BMI measurements will be taken. Body mass index (BMI) will be obtained by dividing the body weight (kg) by the square of the height in meters. After 8-12 hours of fasting, 5 ml of venous blood will be taken from the participants by the nurses of the Medical Oncology Clinic, and the serum obtained after centrifugation will be analyzed in accordance with the manufacturer's kit protocols and in duplicate, the C-reactive protein (CRP) level will be analyzed by the immunoturbidimetric method and the albumin Bromocresol Green-Dye binding method, and chemerin level by enzyme-linked immunoassay (ELISA) method. Nutritional status of individuals will be evaluated with a 24-hour retrospective food consumption record and food consumption frequency questionnaire, and dietary inflammatory index, phytochemical index, and dietary antioxidant capacity will be calculated from the obtained records. In order to measure the inflammatory potential of the diet, the Dietary Inflammatory Index (DII) was developed based on the pro-inflammatory and anti-inflammatory effects of different dietary components on various inflammatory biomarkers. The "Phytochemical Index" method was used to calculate the total phytochemical intake from the diet. The total antioxidant capacity of the diet was calculated using data obtained from dietary intake records based on Ferric Reducing Ability of Plasma (FRAP) methods.

1 tube of blood sample is centrifuged and serum is taken.

Chemerin in Colorectal Cancer and Its Relationship With Diet Quality

Investıgatıon of The Relatıonshıps Between Serum Chemerın Levels, Dıet Qualıty, Inflammatory and Phytochemıcal Indıces in Adults wıth Colorectal Cancer

The blood obtained from individuals after 8-12 hours of fasting will be analyzed in duplicate with the enzyme-linked immunity test (ELISA) method from the serum obtained after centrifugation, in accordance with the manufacturer's kit protocols.

The body weights of the individuals will be measured after 8-12 hours of fasting, using Omron BF511 brand bioelectrical impedance device, wearing light clothes without metal objects.

The body fat percentage of the individuals will be measured after 8-12 hours of fasting, using Omron BF511 brand bioelectrical impedance device, wearing light clothes without metal objects.

The body muscle percentage of the individuals will be measured after 8-12 hours of fasting, using Omron BF511 brand bioelectrical impedance device, wearing light clothes without metal objects.

The visseral fat level of the individuals will be measured by using Omron BF511 brand bioelectrical impedance device while they are on an empty stomach and wearing light clothes without metal objects.

The blood obtained from individuals after 8-12 hours of fasting will be analyzed from the serum obtained after centrifugation, in duplicate using the Bromocresol Green-Dye binding method, in accordance with the manufacturer's kit protocols.

The blood obtained from individuals after 8-12 hours of fasting will be analyzed in duplicate with the immunoturbidimetric method from the serum obtained after centrifugation, in accordance with the manufacturer's kit protocols.

Body mass index (BMI) will be obtained by dividing the body weight (kg) by the square of the height in meters.

The resting metabolic rate of the individuals will be measured by using Omron BF511 brand bioelectrical impedance device while they are on an empty stomach and wearing light clothes without metal objects.

he "Phytochemical Index" method was used to calculate the total phytochemical intake from the diet. The ratio of the total amount of phytochemical rich foods in the diet in grams per day to the total food intake (g/day) will be calculated as follows. The amount of phytochemicals contained in each food will be obtained from the USDA database.

The frequency of food consumption from the participants and the data to be obtained from the twenty-four hour retrospective food consumption record will be evaluated using the Computer Aided Nutrition Program Nutrition Information System (BeBIS 9.0). "Diet inflammatory index" will be calculated by multiplying the nutritional parameters obtained from the recordings with the "inflammatory effect score".The resulting values are summed to obtain the dietary inflammatory index (DII) score, which represents the inflammatory load of the individual's daily diet.

Dietary total antioxidant capacity will be determined using the 'Antioxidant Food Database'. The FRAP value of that food will be calculated by multiplying the reported iron reducing antioxidant power (FRAP) value for each food and the grams of the daily average consumed food. The total antioxidant capacity (TAK) of the diet will be calculated by summing the calculated FRAP values of all foods and expressed as mmol/100 g nutrient.

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
Fruit and Vegetable Intervention in Lactating Women to Reduce Breast Cancer Risk	NCT04374747	Breast Cancer F... Inflammation Postpartum Weig... Diet, Healthy Risk Reduction	Dietary Counsel...	18 Years -	University of Massachusetts, Amherst
With Love, Grandma ("Con Cariño, Abuelita") Pilot Study	NCT05721976	Cancer, Breast Cancer, Uterus Cancer, Ovary Obesity Activity, Motor Diet, Healthy	With Love, Gran...	21 Years -	University of Miami
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
Chemerin in Colorectal Cancer and Its Relationship With Diet Quality	NCT06018077	Colorectal Canc... Diet, Healthy Diet Habit Nutrition Aspec... Inflammation	Dietary İntake,...	19 Years - 64 Years	Hacettepe University

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