NCT06431347RecruitingNot Applicable
Prospective Observational Cohort Study of Transplant and Cell Therapy Candidates and Recipients to Assess Social Determinants of Health
M.D. Anderson Cancer Center1 site in 1 country2,000 target enrollmentStarted: June 17, 2024Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 2,000
- Locations
- 1
- Primary Endpoint
- Social Determinants of Health Questionnaire
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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
Intervention: Social Determinants of Health Questionnaire (Behavioral)
Outcomes
Primary Outcomes
Social Determinants of Health Questionnaire
Time Frame: At 6, 12, 18, and 24 months post Transplant and Cell Therapy
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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