Prospective Observational Cohort Study of Transplant and Cell Therapy Candidates and Recipients to Assess Social Determinants of Health

March 12, 2026 updated by: M.D. Anderson Cancer Center
To learn more about social and financial factors that may influence outcomes of TCT treatment at MD Anderson.

Study Overview

Detailed Description

Primary Objective:

To determine the relationship between participant social determinants of health (SDOH) and outcomes following transplantation and cellular therapy at MDACC.

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Md Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Warren Fingrut, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

MD Anderson Cancer Center

Description

Inclusion Criteria

  1. ≥ 18 years of age.
  2. Received financial clearance for TCT.

Qualitative study - patients

  1. Patient ≥ 18 years of age who is currently cared for at MD Anderson as a TCT candidate/ recipient,
  2. The patient reports social and/or financial challenges impacting care delivery.
  3. The patient is willing to participate in a semi-structured interview.

Qualitative study - caregivers

  1. Caregiver(s) of a patient ≥ 18 years of age who is currently cared for at MD Anderson as a TCT candidate/ recipient.
  2. The patient reports social and/or financial challenges impacting care delivery.
  3. The patient has referred the caregiver(s) to participate and provided us with permission to contact their caregiver(s).
  4. The caregiver(s) is (are) willing to participate in a semi-structured interview.

Exclusion Criteria Patients - Quantitative study 1) Did not receive financial clearance for TCT

Patients - Qualitative study

1) Not impacted by social or financial challenges.

Caregivers (qualitative study)

  1. Did not care for a patient impacted by social or financial challenges
  2. Were not referred to participate in the study by patient they cared for.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Transplant and Cell Therapy Candidates and Recipients

Participants that agree to take part in this study, the study staff will first verify your demographic information (such as age, sex, race, and so on). Participants will then be asked about social barriers to care, including but not limited to:

  • primary language and confidence speaking English
  • education level
  • employment history
  • health literacy
  • legal history
  • caregiver status and literacy
Participants will also complete a questionnaire about financial barriers to care within the past year, including income bracket and difficulty affording cost-of-living or medical expenses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Social Determinants of Health Questionnaire
Time Frame: At 6, 12, 18, and 24 months post Transplant and Cell Therapy
At 6, 12, 18, and 24 months post Transplant and Cell Therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Warren Fingrut, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2024

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2029

Study Registration Dates

First Submitted

May 22, 2024

First Submitted That Met QC Criteria

May 22, 2024

First Posted (Actual)

May 28, 2024

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 2024-0038
  • NCI-2024-04536 (Other Identifier: NCI-CTRP Clinical Registry)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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