Autoimmune Hemolytic Anemia, Brain Function, CAR T-cell Therapy, Psychological Well-Being
Conditions
Brief summary
Cell therapy is an innovative treatment with significant efficacy in hematologic and certain autoimmune diseases. Although it offers potential benefits for autoimmune hemolytic anemia (AIHA), it may result in cognitive and other potential impairments, which can adversely affect patients' cognition and behavior. Brain function and psychological assessment are essential for the early detection of potential impairments, allowing timely interventions to prevent complications and ensure patient safety. This study aims to comprehensively evaluate the physical and psychological impacts of cell therapy on AIHA patients to develop safer and more effective treatment strategies that enhance their quality of life.
Interventions
OTHERBrain function and psychological assessment
Patients will be assessed before cell therapy and on Days 1, 4, 7, 10, 14, 21, and 28 after treatment.
Sponsors
Tianjin University
Institute of Hematology & Blood Diseases Hospital, China
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of AIHA * Subjects will receive cell therapy such as CAR T-cell therapy * Male or female, aged 18-65 years * Willing and able to comply with the requirements for this study and written informed consent
Exclusion criteria
* History of psychiatric illness * History of severe brain disease * Subjects that the investigator believes have other reasons that make them unsuitable for inclusion in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration changes in oxygenated hemoglobin (HbO) and de-oxygenated hemoglobin (HbR) | Patients will be assessed before cell therapy and on Days 1, 4, 7, 10, 14, 21, and 28 after treatment. | Functional Near Infrared Spectroscopy (fNIRS) is a non-invasive brain imaging modality, that can be used to measure HbO and HbR concentrations. |
| Psychological change | Patients will be assessed before cell therapy and on Days 1, 4, 7, 10, 14, 21, and 28 after treatment. | The Big Five Inventory-2(BFI-2) is used to measure the five broad dimensions of personality: openness, conscientiousness, extraversion, agreeableness, neuroticism. Higher scores indicate a stronger presence of that personality trait. |
| Anxiety symptoms | Patients will be assessed before cell therapy and on Days 1, 4, 7, 10, 14, 21, and 28 after treatment. | Hamilton anxiety scale(HAMA) is used to examine anxiety in AIHA patients, with higher total scores indicate more severe anxiety symptoms. The total score range is 0-56. |
| Depression symptoms | Patients will be assessed before cell therapy and on Days 1, 4, 7, 10, 14, 21, and 28 after treatment. | Hamilton depression scale(HAMD) is used to examine depression in AIHA patients, with higher total scores indicate more severe depression symptoms. The total score range is 0-52. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep quality | Patients will be assessed before cell therapy and on Days 1, 4, 7, 10, 14, 21, and 28 after treatment. | The Pittsburgh Sleep Quality Index (PSQI) was used to assess sleep quality, with a higher global score indicating poorer sleep quality. The global score range is 0-21. |
| Physical fatigue | Patients will be assessed before cell therapy and on Days 1, 4, 7, 10, 14, 21, and 28 after treatment. | It measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scale. The total possible score is 0-52 points, with higher scores indicating less fatigue. |
Countries
China
Contacts
Primary ContactZhexiang Kuang, MSN
Backup ContactXiao Yu, Undergraduate
Outcome results
None listed