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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mindfulness intervention.
- Who it may be relevant to
- Registry conditions: Hematopoietic Stem Cell Transplantation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Behavioral Mindfulness 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) Conte
Primary outcome measures
- Change in FACT-BMT Score (Δ Score) [Time frame: baseline to Day 28]
Secondary outcome measures (8)
- Change in HADS score [Time frame: Baseline, Day 28]
- EQ-5D-5L score [Time frame: baseline ，Day 28]
- MoCA cognitive function [Time frame: baseline ，Day 28]
- MRI structural changes [Time frame: Day 0, Day 28]
- Incidence of bloodstream bacterial infections in the transplant unit [Time frame: From Day 0 through discharge]
- Post-Traumatic Growth Inventory (PTGI) [Time frame: baseline, Day 28]
- Subjective Well-Being Scale (SWB) [Time frame: baseline, Day 28]
- Pittsburgh Sleep Quality Index (PSQI) [Time frame: baseline, Day 28]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07127562 · IIT2025078