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

NCT06506396 | Not Yet Recruiting

• 1 other identifier: 2024/0087161_26/06/2024
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Stem Cell Transplantation; Immunotherapy; CAR T-Cell Therapy

Keywords

Functional Status; Quality of life; Needs Assesment; Physical Conditioning, Human; Hematologic Neoplasms

Outcome Measures

Primary Outcomes (2)

• Physical function

  Time up and go (TUG)

  From enrollment up to 8 months later.

• Phyical Function

  Short Physical Performance Battery (SPPB)

  From enrollment up to 8 months later.

Secondary Outcomes (7)

• Strength

  From enrollment up to 8 months later.

• Quality of life

  From enrollment up to 8 months later.

• Fatigue

  From enrollment up to 8 months later.

• Activity of daily living

  From enrollment up to 8 months later.

• Physical activity

  From enrollment up to 8 months later.

Other Outcomes (2)

• Compilcation

  From Treatment up to 8 month

• Legth of stay

  From Treatment up to 8 month

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Modena and Reggio Emilia: lead
• Azienda USL Reggio Emilia - IRCCS: collaborator

Study Sites (1)

AUSL-IRCCS di Reggio Emilia

Reggio Emilia, 42122, Italy

Location

MeSH Terms

Conditions

Motor Activity; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Behavior; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Margherita Schiavi, PhD Candidate

CONTACT

+390522522441; margherita.schiavi@ausl.re.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 17, 2024
• Study Start: August 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)