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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Modena and Reggio Emilia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

20 Participants
are grouped into 1 trial group
Group A: Patients with hematologic cancer scheduled to undergo HSCT or CAR T-cell therapy

Trial outcomes

Primary outcomes

1

Physical function

Time up and go (TUG)

Time frame
From enrollment up to 8 months later.
2

Phyical Function

Short Physical Performance Battery (SPPB)

Time frame
From enrollment up to 8 months later.

Secondary outcomes

1

Strength

Handgrip strength test

Time frame
From enrollment up to 8 months later.
2

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

Time frame
From enrollment up to 8 months later.
3

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.

Time frame
From enrollment up to 8 months later.
4

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.

Time frame
From enrollment up to 8 months later.

Other outcomes

1

Compilcation

Treatment complication

Time frame
From Treatment up to 8 month
2

Legth of stay

Days of hospitalisation

Time frame
From Treatment up to 8 month

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Modena and Reggio Emilia

Lead sponsor

Azienda USL Reggio Emilia - IRCCS

Collaborator

This trial is not recruiting at the moment. You can still explore other options: