Hematopoietic Stem Cell Transplantation
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALMindfulness intervention
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): 1. 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; 2. 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;
Sponsors
Institute of Hematology & Blood Diseases Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged 18 years or older. 2. Scheduled to receive either autologous or allogeneic HSCT. 3. Anticipated inpatient stay in the transplant unit of at least 21 days.
Exclusion criteria
1. Prior history of hematopoietic stem cell transplantation (HSCT). 2. Active psychiatric disorder or cognitive impairment. 3. Systematic training in mindfulness/mindfulness-based interventions/yoga within the past 3 months. 4. Contraindications to MRI.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in FACT-BMT Score (Δ Score) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EQ-5D-5L score | baseline ，Day 28 | Includes 5-dimensional scores and Visual Analog Scale (VAS) ratings to reflect subjective health status |
| MoCA cognitive function | baseline ，Day 28 | Evaluating cognitive performance. |
| MRI structural changes | Day 0, Day 28 | Hippocampal volume, dorsolateral prefrontal cortex (DLPFC) thickness, and surface area |
| Change in HADS score | Baseline, Day 28 | Assessing trends in emotional improvement. |
| Post-Traumatic Growth Inventory (PTGI) | baseline, Day 28 | Assessing the degree of personal growth following traumatic experiences |
| Subjective Well-Being Scale (SWB) | baseline, Day 28 | Measuring life satisfaction and quantifying emotional experiences |
| Pittsburgh Sleep Quality Index (PSQI) | baseline, Day 28 | Quantifying sleep quality |
| Incidence of bloodstream bacterial infections in the transplant unit | From Day 0 through discharge | Including the number of positive bacterial blood cultures |
Contacts
Primary Contacterlie jiang, doctor
Outcome results
None listed