Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06506396
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
Rehabilitation Needs for Hematologic Cancer Candidate for Hematopoietic Stem Cell Transplantation or CAR T-Cell Therapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Outcomes and Rehabilitation Needs of Patients With Hematologic Cancer Candidate for Hematopoietic Stem Cell Transplantation or CAR T-Cell Therapy a Prospective Observational Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HEMATOneeds
Brief Summary:
Hematopoietic Stem Cell Transplantation HSCT and CAR T-cell therapy are effective treatments for blood cancers extending patients lives However these treatments can cause side effects like muscle weakness and fatigue Recent findings suggest these issues can significantly affect patient quality of life during CAR T-cell therapy
Patients undergoing HSCT and CAR T-cell therapy often face frequent infections and strong immune responses requiring long periods of rest This worsens their physical condition and impacts their quality of life muscle strength and fatigue levels Minimizing these side effects is crucial to improve the well-being of patients undergoing these advanced treatments
This study aims to assess the physical abilities main goal of patients preparing for HSCT or CAR T-cell therapy It also aims to examine their quality of life and describe the symptoms and complications they may experience The results will help identify rehabilitation needs for these patients
Patients undergoing HSCT and CAR T-cell therapy often face frequent infections and strong immune responses requiring long periods of rest This worsens their physical condition and impacts their quality of life muscle strength and fatigue levels Minimizing these side effects is crucial to improve the well-being of patients undergoing these advanced treatments
This study aims to assess the physical abilities main goal of patients preparing for HSCT or CAR T-cell therapy It also aims to examine their quality of life and describe the symptoms and complications they may experience The results will help identify rehabilitation needs for these patients
Detailed Description:
This is a prospective observational study following STROBE guidelines for observational studies in epidemiology The study will take place at the Azienda USL-IRCCS di Reggio Emilia Northern Italy
Participants will include adults with blood cancer scheduled for HSCT or CAR T-cell therapy They must be able to understand and speak Italian and make an informed decision to participate in the study
Patients will be identified at the Hematology Unit of Azienda USL-IRCCS di Reggio Emilia Medical records will be reviewed to confirm eligibility Eligible patients will receive detailed information about the study and can decide to participate by signing a consent form
The study will last 24 months with an 8-month enrollment period and an 8-month follow-up Approximately 20 participants will be enrolled based on the number of patients who received HSCT and CAR T-cell therapy in 2023
Data on participants Sociodemographic and clinical characteristics will be collected at the start of the study Complications and hospitalizations will be monitored after treatments to understand their impact on patients health
This study aims to provide valuable insights into the rehabilitation needs of patients undergoing HSCT and CAR T-cell therapy
Participants will include adults with blood cancer scheduled for HSCT or CAR T-cell therapy They must be able to understand and speak Italian and make an informed decision to participate in the study
Patients will be identified at the Hematology Unit of Azienda USL-IRCCS di Reggio Emilia Medical records will be reviewed to confirm eligibility Eligible patients will receive detailed information about the study and can decide to participate by signing a consent form
The study will last 24 months with an 8-month enrollment period and an 8-month follow-up Approximately 20 participants will be enrolled based on the number of patients who received HSCT and CAR T-cell therapy in 2023
Data on participants Sociodemographic and clinical characteristics will be collected at the start of the study Complications and hospitalizations will be monitored after treatments to understand their impact on patients health
This study aims to provide valuable insights into the rehabilitation needs of patients undergoing HSCT and CAR T-cell therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None