Recruiting

Observational Study

Sponsor:

University of Kansas Medical Center

Code:

NCT06802406

Conditions

ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION

Autologous Haemopoietic Stem Cell Transplant

CAR-T Cell Therapy

Food Insecurity

Eligibility Criteria

Sex: All

Age: 8 - 70+

Healthy Volunteers: Not accepted

Interventions

Food Bags

Study Details

Brief summary:

Many children and adults receiving medical treatments have higher costs, which can make it harder for them to afford groceries. When someone can't afford enough food, and they do not receive proper nutrition it can make treatment more difficult.

By doing this study investigators hope to learn more about whether addressing food insecurity by giving patients bags of food in clinic can help improve nutrition, reduce costs, and improve transplant and cellular therapy outcomes.

Conditions

ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION

Autologous Haemopoietic Stem Cell Transplant

CAR-T Cell Therapy

Food Insecurity

Study ID

NCT06802406

Start date

May 1, 2025

Status verified date

Apr, 2026

Completion date

May, 2029

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Planning to receive transplant or cell therapy
  • Screen positive for food insecurity by answering "often true" or "sometimes true" to one of the following:

  • "Within the past 12 months, you worried that your food would run out before you got money to buy more,"
  • "Within the past 12 months, the food you bought just didn't last and you didn't have money to get more."
  • Age 8 - 80
  • Able to read/write English or Spanish (many patient-reported outcome measures lack validated translations in other languages)

Exclusion Criteria:

  • Patients who do not tolerate oral nutrition at the time of study enrollment

Study Design

Enrollment

210 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

no intervention: Information Group

These participants will receive information on their local food banks according to standard of care.

experimental: Food Bags Group

Patients will be given bags of shelf-stable food for 2-3 days for one individual twice a week in clinic. Additionally, they will receive recipes, handouts, and videos to help with education and food preparation.

Interventions

Food Bags

Participants will receive bags of shelf-stable food for 2-3 days for one individual twice a week in clinic. They will also receive recipes, handouts, and videos to help with education and food preparation.

Primary outcome measure

  • Peri-Transplant and Cell Therapy Malnutrition [ Time Frame: Through Day 100 ]

Central Contacts and Locations

Central contacts

Anthony Sung, MD

913-588-1227asung2@kumc.edu

Locations

University of Kansas Cancer Center

Recruiting

Fairway, Kansas, United States, 66205

Contacts

Anthony Sung, MD

913-588-1227asung2@kumc.edu

Principal Investigator:

Anthony Sung, MD

More Information

Sponsor

University of Kansas Medical Center

Last update posted

Apr 20, 2026

Last verified

Apr, 2026

Keywords

  • nutrition, food insecurity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2026-04-20.