Effect of a Simplified Mindfulness Intervention on Health-related Quality of Life in Patients Undergoing Hematopoietic Stem Cell Transplantation: A Prospective Single-Center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 148
- 主要终点
- Change in FACT-BMT Score (Δ Score)
研究概览
简要总结
This study aims to evaluate the impact of a simplified mindfulness intervention (daily mindfulness breathing and body scanning) during hospitalization in the transplant ward on health-related quality of life in hematopoietic stem cell transplantation patients.
详细描述
All patients undergo standardized HSCT treatment, which does not interfere with the management of their underlying conditions. Patients are randomly assigned to either the 'Mindfulness Intervention Group' or the 'Conventional Support Group' based on age (whether over 40) and transplant type (autologous or allogeneic), in a 1:1 ratio. The study period is at least 21 days, during which patients are hospitalized in the transplant ward.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Aged 18 years or older.
- •Scheduled to receive either autologous or allogeneic HSCT.
- •Anticipated inpatient stay in the transplant unit of at least 21 days.
排除标准
- •Prior history of hematopoietic stem cell transplantation (HSCT).
- •Active psychiatric disorder or cognitive impairment.
- •Systematic training in mindfulness/mindfulness-based interventions/yoga within the past 3 months.
- •Contraindications to MRI.
研究组 & 干预措施
Mindfulness intervention group
- Mindfulness intervention group: Intermittent period: from the first day to at least the 21st day, and up to the 28th day, continuous implementation
Content of intervention (daily completion):
- Mindfulness breathing exercise (10 minutes) Content: Close your eyes to perceive the breath coming in and out, pay attention to the present moment, without judgment; Tools: Chinese voice-guided audio (nurses check room or patients scan code to play); Time: to be completed between 9am and 10am;
- Body Scan Exercise (15 minutes) Content: gradually perceive the tension, pain or relaxation of each part of the body from head to toe; Tools: Chinese audio guidance, which can be played during the infusion or before going to bed; Time: between 7-8pm;
干预措施: Mindfulness intervention (Behavioral)
Conventional support group
received conventional nursing and rehabilitation guidance, but did not receive mindfulness intervention. The control group patients received conventional hospital nursing services during the study period, including disease monitoring, drug treatment, rehabilitation guidance, etc., but did not receive any form of mindfulness training or other similar psychological interventions.
结局指标
主要结局
Change in FACT-BMT Score (Δ Score)
时间窗: baseline to Day 28
The daily trajectory of FACT-BMT total scores during hospitalization will be continuously monitored in both the mindfulness intervention group and the routine support group. The difference between the lowest daily score and the baseline score (Δ nadir) will be calculated to reflect the maximum decline in quality of life during hospitalization. A comparison will be made between the two groups to determine whether there is a difference in the maximum reduction of FACT-BMT total scores during hospitalization, thereby evaluating the mitigating effect of mindfulness intervention on the deterioration of quality of life.
次要结局
- MoCA cognitive function(baseline ，Day 28)
- Subjective Well-Being Scale (SWB)(baseline, Day 28)
- Pittsburgh Sleep Quality Index (PSQI)(baseline, Day 28)
- Change in HADS score(Baseline, Day 28)
- EQ-5D-5L score(baseline ，Day 28)
- Incidence of bloodstream bacterial infections in the transplant unit(From Day 0 through discharge)
- Post-Traumatic Growth Inventory (PTGI)(baseline, Day 28)
- MRI structural changes(Day 0, Day 28)