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NCT Number: NCT07127562

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

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.

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Key information

Conditions

Hematopoietic Stem Cell Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindfulness Intervention

Behavioral

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;

Primary outcomes

  1. Change in FACT-BMT Score (Δ Score)

    Time frame: 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 outcomes

  1. Change in HADS score

    Time frame: Baseline, Day 28

    Assessing trends in emotional improvement.

  2. EQ-5D-5L score

    Time frame: baseline ，Day 28

    Includes 5-dimensional scores and Visual Analog Scale (VAS) ratings to reflect subjective health status

  3. MoCA cognitive function

    Time frame: baseline ，Day 28

    Evaluating cognitive performance.

  4. MRI structural changes

    Time frame: Day 0, Day 28

    Hippocampal volume, dorsolateral prefrontal cortex (DLPFC) thickness, and surface area

  5. Incidence of bloodstream bacterial infections in the transplant unit

    Time frame: From Day 0 through discharge

    Including the number of positive bacterial blood cultures

  6. Post-Traumatic Growth Inventory (PTGI)

    Time frame: baseline, Day 28

    Assessing the degree of personal growth following traumatic experiences

  7. Subjective Well-Being Scale (SWB)

    Time frame: baseline, Day 28

    Measuring life satisfaction and quantifying emotional experiences

  8. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: baseline, Day 28

    Quantifying sleep quality

Study contacts

Contact information is provided by the study sponsor or research team.

erlie jiang, doctor

CONTACT

[email protected]

02223608600

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 17, 2025
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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