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

NCT07127562 | Not Yet Recruiting

• 1 other identifier: IIT2025078
• Study Type: interventional
• Target: 148
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hematopoietic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (1)

• Change in FACT-BMT Score (Δ Score)

  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.

  baseline to Day 28

Secondary Outcomes (8)

• Change in HADS score

  Baseline, Day 28

• EQ-5D-5L score

  baseline ，Day 28

• MoCA cognitive function

  baseline ，Day 28

• MRI structural changes

  Day 0, Day 28

• Incidence of bloodstream bacterial infections in the transplant unit

  From Day 0 through discharge

Study Arms (2)

Mindfulness intervention group

EXPERIMENTAL

1\. 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): 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;

Behavioral: Mindfulness intervention

Conventional support group

NO INTERVENTION

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.

Interventions

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): 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;

Mindfulness intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Central Study Contacts

erlie jiang, doctor

CONTACT

02223608600; jiangerlie@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 17, 2025
• Study Start: August 7, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 17, 2025

Record last verified: 2025-07