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

Outcomes and Rehabilitation Needs of Patients With Hematologic Cancer Candidate for Hematopoietic Stem Cell Transplantation or CAR T-Cell Therapy: a Prospective Observational Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stem Cell Transplantation; Immunotherapy; CAR T-Cell Therapy

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.

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Margherita Schiavi, PhD Candidate; Phone Number: +390522522441; Email: margherita.schiavi@ausl.re.it

Study Locations

• Italy
  • Reggio Emilia, Italy, 42122
    • AUSL-IRCCS di Reggio Emilia
    • Contact: Margherita Schiavi, Phd Candidate; Phone Number: 441 +390522522; Email: margherita.schiavi@ausl.re.it
    • Contact: Stefania Costi, PhD, Researcher; Phone Number: 441 +390522522441; Email: stefania.costi@unimore.it
    • Principal Investigator: Margherita Schiavi, PhD Candidate

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Strength	Handgrip strength test	From enrollment up to 8 months later.
Quality of life	European Organization for Research and Treatment of Cancer QoL Questionnaire-C30 -QLQ C30. This questionnaire will be administered to assess participants' quality of life. It comprises one global scale, five functional scales, three symptom scales, and six single item scale.All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems	From enrollment up to 8 months later.
Fatigue	Functional Assesment of Chronic IIlness Therapy-Fatigue.the total score range is 0 to 52. The general population mean score is 43. Lower scores indicate greater fatigue.	From enrollment up to 8 months later.
Activity of daily living	Duke Activities Score Index (DASI).The DASI is a 12-item questionnaire that asses daily activities in the following domain: productivity, self-care, and leisure time. Total score ranges from 0 to 58.2. Higher scores indicate higher self-perceived functional ability.	From enrollment up to 8 months later.
Physical activity	International Physical Activities Questionnarie_Short Form (IPAQ-SF).This self-reported questionnaire provides information on the intensity, duration, and frequency of various physical activities, offering valuable insights into participants' overall activity levels. In addition, Metabolic Equivalent of Tasks (METs) are used to classifies the level of patients' physical activity as low (<600 MET), moderate (from 600 to 3000 MET), or high (≥ 3000 MET)	From enrollment up to 8 months later.
KInesiophobia	Tampa Scale of Kinesiophobia (TSK)The 17 item TSK total scores range from 17 to 68 where the lowest 17 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia	From enrollment up to 8 months later.
Walking ability	Functional Ambulation Category (FAC).Clinician-completed tick box of 5 broad categories of walking ability, ranges from independent walking outside (score 5) to non-functional walking (score 0).	From enrollment up to 8 months later.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compilcation	Treatment complication	From Treatment up to 8 month
Legth of stay	Days of hospitalisation	From Treatment up to 8 month

Collaborators and Investigators

• Sponsor: University of Modena and Reggio Emilia
• Collaborators: Azienda Unita Sanitaria Locale Reggio Emilia

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: July 11, 2024
• First Submitted That Met QC Criteria: July 11, 2024
• First Posted (Actual): July 17, 2024

Study Record Updates

• Last Update Posted (Actual): July 19, 2024
• Last Update Submitted That Met QC Criteria: July 17, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Quality of life; Hematologic Neoplasms; Functional Status; Physical Conditioning, Human; Needs Assesment
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: 2024/0087161_26/06/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD are sensible data and then will not be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No