Rehabilitation Needs for Hematologic Cancer Candidate for Hematopoietic Stem Cell Transplantation or CAR T-Cell Therapy

NCT ID: NCT06506396

Last Updated: 2024-07-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-08-31
• Study Completion Date: 2025-05-31

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.

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.

Conditions

Stem Cell Transplantation; Immunotherapy; CAR T-Cell Therapy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with hematologic cancer scheduled to undergo HSCT or CAR T-cell therapy

The participants will be selected at the Hematology Unit of Azienda USL-IRCCS di Reggio Emilia, Northern Italy, two months prior to undergoing transplantation or CAR-T cell treatment. Eligible participants must meet the following inclusion criteria: have hematologic cancer and be scheduled for HSCT or CAR T-cell therapy; be at least 18 years old; able to provide informed consent and actively participate in the study; proficient in understanding and communicating in Italian.

Patients who are unable to perform physical tests or have contraindications to movement will be excluded from the study

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients with hematologic cancer scheduled to undergo HSCT or CAR T-cell therapy;
• Age ≥18 years
• Able to provide informed consent to participate in the study
• Able to understand and participate in the study
• Able to understand and communicate in the Italian language

Exclusion Criteria

• Patients who are unable to perform physical tests or have contraindications to movement

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda USL Reggio Emilia - IRCCS

OTHER_GOV

Sponsor Role: collaborator

University of Modena and Reggio Emilia

OTHER

Sponsor Role: lead

Responsible Party

Stefania Costi

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

AUSL-IRCCS di Reggio Emilia

Reggio Emilia, , Italy

Countries

Italy

Central Contacts

Margherita Schiavi, PhD Candidate

Role: CONTACT

margherita.schiavi@ausl.re.it

+390522522441

Facility Contacts

Margherita Schiavi, Phd Candidate

Role: primary

margherita.schiavi@ausl.re.it

+390522522 ext. 441

Stefania Costi, PhD, Researcher

Role: backup

stefania.costi@unimore.it

+390522522441 ext. 441

Other Identifiers

2024/0087161_26/06/2024

Identifier Type: -

Identifier Source: org_study_id