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

NCT ID: NCT06431347

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-17

Study Completion Date

2029-06-01

Brief Summary

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To learn more about social and financial factors that may influence outcomes of TCT treatment at MD Anderson.

Detailed Description

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Primary Objective:

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

Conditions

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Transplant and Cell Therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Social Determinants of Health Questionnaire

Intervention Type BEHAVIORAL

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.

Interventions

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Social Determinants of Health Questionnaire

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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 - 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Warren Fingrut, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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MD Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Warren Fingrut, MD

Role: CONTACT

(832) 387-8363

Facility Contacts

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Warren Fingrut, MD

Role: primary

832-387-8363

Related Links

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http://www.mdanderson.org

MD Anderson Cancer Center

Other Identifiers

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NCI-2024-04536

Identifier Type: OTHER

Identifier Source: secondary_id

2024-0038

Identifier Type: -

Identifier Source: org_study_id

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