Rehabilitation Needs for Hematologic Cancer Candidate for Hematopoietic Stem Cell Transplantation or CAR T-Cell Therapy
NCT Number: NCT06506396
Acronym: HEMATOneeds
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Stem Cell Transplantation|Immunotherapy|CAR T-Cell Therapy
Sponsor: University of Modena and Reggio Emilia
Collaborators: Azienda Unità Sanitaria Locale Reggio Emilia
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2025-05
Locations: AUSL-IRCCS di Reggio Emilia, Reggio Emilia, 42122, Italy

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.

Primary Outcome Measures: 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: 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: Compilcation, Treatment complication, From Treatment up to 8 month|Legth of stay, Days of hospitalisation, From Treatment up to 8 month