- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06431347
Prospective Observational Cohort Study of Transplant and Cell Therapy Candidates and Recipients to Assess Social Determinants of Health
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Warren Fingrut, MD
- Phone Number: (832) 387-8363
- Email: wbfingrut@mdanderson.org
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- MD Anderson Cancer Center
-
Contact:
- Warren Fingrut, MD
- Phone Number: 832-387-8363
- Email: wbfingrut@mdanderson.org
-
Principal Investigator:
- Warren Fingrut, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria
- ≥ 18 years of age.
- Received financial clearance for TCT.
Qualitative study - patients
- Patient ≥ 18 years of age who is currently cared for at MD Anderson as a TCT candidate/ recipient,
- The patient reports social and/or financial challenges impacting care delivery.
- The patient is willing to participate in a semi-structured interview.
Qualitative study - caregivers
- Caregiver(s) of a patient ≥ 18 years of age who is currently cared for at MD Anderson as a TCT candidate/ recipient.
- The patient reports social and/or financial challenges impacting care delivery.
- The patient has referred the caregiver(s) to participate and provided us with permission to contact their caregiver(s).
- 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)
- Did not care for a patient impacted by social or financial challenges
- Were not referred to participate in the study by patient they cared for.
Study Plan
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:
|
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
Sponsor
Investigators
- Principal Investigator: Warren Fingrut, MD, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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
Studies a U.S. FDA-regulated device product
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.