Outcomes and Rehabilitation Needs of Patients With Hematologic Cancer Candidate for Hematopoietic Stem Cell Transplantation or CAR T-Cell Therapy: a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Phyical Function
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients who are unable to perform physical tests or have contraindications to movement
结局指标
主要结局
Phyical Function
时间窗: From enrollment up to 8 months later.
Short Physical Performance Battery (SPPB)
Physical function
时间窗: From enrollment up to 8 months later.
Time up and go (TUG)
次要结局
- Strength(From enrollment up to 8 months later.)
- Physical activity(From enrollment up to 8 months later.)
- Quality of life(From enrollment up to 8 months later.)
- Activity of daily living(From enrollment up to 8 months later.)
- KInesiophobia(From enrollment up to 8 months later.)
- Fatigue(From enrollment up to 8 months later.)
- Walking ability(From enrollment up to 8 months later.)
研究者
Stefania Costi
Researcher
University of Modena and Reggio Emilia