## Protocol Section
### Identification Module
**NCT ID:** NCT06431347

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

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

#### Organization Study ID Info
**ID:** 2024-0038
#### Organization
**Class:** OTHER
**Full Name:** M.D. Anderson Cancer Center
#### Secondary ID Infos
**Domain:** NCI-CTRP Clinical Registry
**ID:** NCI-2024-04536
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2029-06-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-29

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2027-06-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-11-29

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** M.D. Anderson Cancer Center

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

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

**Detailed Description:** Primary Objective:

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

### Conditions Module

**Conditions:**

- Transplant and Cell Therapy

**Keywords:**

- Social Determinants of Health

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 2000

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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

**Intervention Names:**

- Behavioral: Social Determinants of Health Questionnaire

**Label:** Transplant and Cell Therapy Candidates and Recipients

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Transplant and Cell Therapy Candidates and Recipients

**Description:** 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.

**Name:** Social Determinants of Health Questionnaire

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Measure:** Social Determinants of Health Questionnaire

**Time Frame:** At 6, 12, 18, and 24 months post Transplant and Cell Therapy

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria

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

Exclusion Criteria

1) Did not receive financial clearance for TCT

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** MD Anderson Cancer Center

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** wbfingrut@mdanderson.org

**Name:** Warren Fingrut, MD

**Phone:** (832) 387-8363

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Houston

**Contacts:**

***Contact 1:***

- **Email:** wbfingrut@mdanderson.org

- **Name:** Warren Fingrut, MD

- **Phone:** 832-387-8363

- **Role:** CONTACT

***Contact 2:***

- **Name:** Warren Fingrut, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** MD Anderson Cancer Center

**State:** Texas

**Zip:** 77030

#### Overall Officials

**Official 1:**

**Affiliation:** M.D. Anderson Cancer Center

**Name:** Warren Fingrut, MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### See Also Links

**Label:** MD Anderson Cancer Center

**URL:** http://www.mdanderson.org

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
