Clinical trial NCT06506396: Rehabilitation Needs for Hematologic Cancer Candidate for Hematopoietic Stem Cell Transplantation or CAR T-Cell Therapy
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Stem Cell Transplantation
Immunotherapy
CAR T-Cell Therapy
Keywords: Functional Status
Quality of life
Needs Assesment
Physical Conditioning, Human
Hematologic Neoplasms
Lead sponsor: University of Modena and Reggio Emilia
Sponsor class: OTHER
Collaborators: name: Azienda USL Reggio Emilia - IRCCS
First posted: 2024-07-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The potential participants will be selected at the Hematology Unit of the Azienda USL-IRCCS di Reggio Emilia among patients undergoing hematopoietic stem cell transplantation or CAR T-cell treatment, identified two months prior to their treatment.

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.

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

Primary outcomes:
measure: Physical function
timeFrame: From enrollment up to 8 months later.
measure: Phyical Function
timeFrame: From enrollment up to 8 months later.
Secondary outcomes:
measure: Strength
timeFrame: From enrollment up to 8 months later.
measure: Quality of life
timeFrame: From enrollment up to 8 months later.
measure: Fatigue
timeFrame: From enrollment up to 8 months later.
measure: Activity of daily living
timeFrame: From enrollment up to 8 months later.
measure: Physical activity
timeFrame: From enrollment up to 8 months later.
measure: KInesiophobia
timeFrame: From enrollment up to 8 months later.
measure: Walking ability
timeFrame: From enrollment up to 8 months later.
Other outcomes:
measure: Compilcation
timeFrame: From Treatment up to 8 month
measure: Legth of stay
timeFrame: From Treatment up to 8 month
Locations:
city: Reggio Emilia
country: Italy
facility: AUSL-IRCCS di Reggio Emilia
Study officials:
References: