Hematopoietic Stem Cell TransplantationNCT07127562
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
A study testing Mindfulness intervention in people with Hematopoietic Stem Cell Transplantation, run by Institute of Hematology & Blood Diseases Hospital, China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic Stem Cell Transplantation
- What is being tested?
- Mindfulness intervention
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- No sites listed yet
- Study dates
- 7 Aug 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Hematopoietic Stem Cell Transplantation
- Being tested
- Mindfulness intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness interventionBehavioural
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;
| Study group | Role | What they receive |
|---|---|---|
| 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; Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline to Day 28
Secondary outcomes (8)
Change in HADS score
Assessing trends in emotional improvement.
Measured: Baseline, Day 28
EQ-5D-5L score
Includes 5-dimensional scores and Visual Analog Scale (VAS) ratings to reflect subjective health status
Measured: baseline ，Day 28
MoCA cognitive function
Evaluating cognitive performance.
Measured: baseline ，Day 28
MRI structural changes
Hippocampal volume, dorsolateral prefrontal cortex (DLPFC) thickness, and surface area
Measured: Day 0, Day 28
Incidence of bloodstream bacterial infections in the transplant unit
Including the number of positive bacterial blood cultures
Measured: From Day 0 through discharge
Post-Traumatic Growth Inventory (PTGI)
Assessing the degree of personal growth following traumatic experiences
Measured: baseline, Day 28
Subjective Well-Being Scale (SWB)
Measuring life satisfaction and quantifying emotional experiences
Measured: baseline, Day 28
Pittsburgh Sleep Quality Index (PSQI)
Quantifying sleep quality
Measured: baseline, Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start7 Aug 2025 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07127562
- Sponsor's protocol ID
- IIT2025078
- Status last verified
- Jul 2025
- First submitted
- 11 Aug 2025
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07127562
- Acronym / sponsor ID
- IIT2025078
- Conditions
- Hematopoietic Stem Cell Transplantation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 7 Aug 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness intervention group | Experimental | Behavioral: Mindfulness intervention1. 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; |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness interventionIntermittent 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; | Behavioural | Mindfulness intervention group |
Primary outcome
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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness intervention in people with Hematopoietic Stem Cell Transplantation, run by Institute of Hematology & Blood Diseases Hospital, China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact erlie jiang, doctor (02223608600, jiangerlie@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in FACT-BMT Score (Δ Score) (time frame: baseline to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.