Chronic Graft Versus Host DiseaseNCT07733141
Mindfulness Intervention to Reduce Patient Reported Symptoms in Patients With Chronic Graft-Versus-Host Disease
A study testing Biospecimen Collection, Mindfulness Relaxation and Survey Administration in people with Chronic Graft Versus Host Disease and Hematopoietic and Lymphatic System Neoplasm, run by City of Hope Medical Center at 1 site in United States.
Trial summary
This clinical trial tests a mindfulness intervention, consisting of group sessions and an individual session, using mindfulness based stress reduction techniques, to reduce patient reported symptoms for patients with chronic graft versus host disease (cGVHD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Graft Versus Host Disease, Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Biospecimen Collection, Mindfulness Relaxation and Survey Administration
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2027to 8 Apr 2028
- 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
- Documented informed consent of the participant and/or legally authorized representative
- Willingness to participate in the study
- Willingness to attend in-person or virtual group sessions
- Ability to read and understand English (required for protocol therapy and planned survey)
- Age: ≥ 18 years
- Confirmed diagnosis of moderate/severe chronic graft-versus-host disease by National Institute of Health (NIH) criteria
- Karnofsky performance status ≥ 80
Who cannot join
- Previous participation in four or more sessions of mindfulness-based cognitive therapy (MBCT)/ mindfulness-based stress reduction (MBSR)
- An increase in anti-cGvHD medication (increased dosage or addition of a new medication) within 4 weeks prior to baseline evaluation
- Severe psychiatric comorbidities (active psychosis, suicidal ideation) as determined by primary investigator (PI)
- Concurrent malignancy, autoimmune disease, chronic infections, or other chronic inflammatory illness that might confound the results as determined by the PI
- Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
City of Hope Medical Center
Duarte, California, 91010
Amandeep Salhotra, 626-218-2405, asalhotra@coh.org
Amandeep Salhotra
About this study
Official title: Pilot Feasibility Study of Mindfulness-Based Intervention in Patients With Chronic Graft-Versus-Host Disease
This clinical trial tests a mindfulness intervention, consisting of group sessions and an individual session, using mindfulness based stress reduction techniques, to reduce patient reported symptoms for patients with chronic graft versus host disease (cGVHD). In patients undergoing allogeneic stem cell transplant, sometimes the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease). In cGVHD patients may encounter stiffness, itching, joint and muscle pain, oral cavity pain, itchy eyes, shortness of breath, depression, anxiety, and poor sleep resulting in a significant impact on patients' quality of life. Mindfulness interventions use meditation practices with elements of psychology to improve emotional regulation, resilience and acceptance based coping. This mindfulness based intervention may reduce patient reported symptoms in patients with cGVHD.
Read the detailed description
PRIMARY OBJECTIVE:
- Assess the feasibility of an 8-week mindfulness-based intervention (MBI) program consisting of weekly group sessions and a practitioner/patient 1:1 session in patients with a diagnosis of chronic graft-versus-host disease (cGVHD).
SECONDARY OBJECTIVES:
- Determine the number of patients who withdraw consent before starting group sessions or do not attend any of the planned group sessions.
II. Assess the feasibility of daily self-meditation in patients with a diagnosis of cGVHD.
III. Estimate the preliminary efficacy of the MBI program in patients with cGVHD.
EXPLORATORY OBJECTIVE:
- Examine potential associations between the MBI program and the following at baseline, Week 4, and at completion of the MBI program.
OUTLINE:
Patients complete group sessions once weekly (QW), on weeks 1-4, over 40 minutes, and on weeks 6-8, over 60 minutes, and an individual session, over 60 minutes, on week 5. Sessions consist of instruction on diaphragmatic breathing, body scan, visualization, and individual mediation practice. Patients are recommended to complete self mediation daily for at least 15 minutes, for 8 weeks. Patients undergo blood sample collection throughout the study.
- Conditions
- Chronic Graft Versus Host Disease, Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
- Being tested
- Biospecimen Collection, Mindfulness Relaxation, Survey Administration
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo blood sample collection
Mindfulness RelaxationBehavioural
Also called MBSR, Mindful Meditation, Mindfulness Meditation, Mindfulness-Based Stress Reduction
Complete group mindfulness sessions
Mindfulness RelaxationBehavioural
Also called MBSR, Mindful Meditation, Mindfulness Meditation, Mindfulness-Based Stress Reduction
Complete individual mindfulness session
Mindfulness RelaxationBehavioural
Also called MBSR, Mindful Meditation, Mindfulness Meditation, Mindfulness-Based Stress Reduction
Complete daily self meditation
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (mindfulness based intervention) | Experimental | Patients complete group sessions QW, on weeks 1-4, over 40 minutes, and on weeks 6-8, over 60 minutes, and an individual session, over 60 minutes, on week 5. Sessions consist of instruction on diaphragmatic breathing, body scan, visualization, and individual mediation practice. Patients are recommended to complete self mediation daily for at least 15 minutes, for 8 weeks. Patients undergo blood sample collection throughout the study. Receives: Procedure: Biospecimen Collection; Behavioral: Mindfulness Relaxation; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance (feasibility)
Feasibility is defined as 12 or more of 15 evaluable participants meet compliance criteria. Compliance for each participant will be a binary endpoint (yes versus no). If a participant completes 5/7 group sessions, the practitioner/patient 1:1 session, and end of treatment assessments, compliance is defined as yes. Will be summarized using the percentage and 90% confidence intervals.
Measured: Up to 8 weeks
Secondary outcomes (4)
Reason for not starting study activities after signing consent
For participants who withdraw consent before starting group sessions or do not attend any of the planned group sessions, the reason for not starting study activities after signing consent will be recorded for each patient
Measured: Up to 8 weeks
Feasibility of daily meditation in patients with a diagnosis of cGVHD
Feasibility of daily meditation will be assessed weekly and will be defined as 4/7 days per week in which the participant logged at least 15 minutes of individual meditation
Measured: Up to 8 weeks
Decrease of > 5 points on the 7-day Modified Lee Chronic Graft Versus Host Disease Symptom Scale (MLSS
Participants will self-report the level of distress they experienced in the previous week for each of the 28-items on a scale of 0 to 4, with 0 representing "not at all", 1 "slightly", 2 "moderately", 3 "quite a bit", and 4 "extremely". Items will be added to create a total score, which can range from 0 to 100, with a higher score indicating a higher overall symptom burden
Measured: From baseline to completion of mindfulness based intervention (MBI) program, up to 8 weeks
Decrease in cGVHD severity stage per 2014 NIH consensus cGVHD grading criteria
Decrease of one full organ stage (e.g., Stage 1 to Stage 2), or a clear functional change like a 2-point P-ROM score shift per 2014 NIH consensus cGVHD grading criteria
Measured: From baseline to completion of MBI program, up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start1 Mar 2027 (estimated)
- Primary completion8 Apr 2028 (estimated)
- Study completion8 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Graft Versus Host DiseaseStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Amandeep Salhotra, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07733141
- Sponsor's protocol ID
- 25870
- Other IDs
- NCI-2026-04201, 25870, P30CA033572
- Status last verified
- Oct 2026
- First submitted
- 25 Jun 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Feasibility Study of Mindfulness-Based Intervention in Patients With Chronic Graft-Versus-Host Disease
- ClinicalTrials.gov ID
- NCT07733141
- Acronym / sponsor ID
- 25870
- Conditions
- Chronic Graft Versus Host Disease, Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Mar 2027 (estimated)
- Primary completion
- 8 Apr 2028 (estimated)
- Study completion
- 8 Apr 2028 (estimated)
- First posted
- 29 Jul 2026 (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 clinical trial tests a mindfulness intervention, consisting of group sessions and an individual session, using mindfulness based stress reduction techniques, to reduce patient reported symptoms for patients with chronic graft versus host disease (cGVHD). In patients undergoing allogeneic stem cell transplant, sometimes the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease). In cGVHD patients may encounter stiffness, itching, joint and muscle pain, oral cavity pain, itchy eyes, shortness of breath, depression, anxiety, and poor sleep resulting in a significant impact on patients' quality of life. Mindfulness interventions use meditation practices with elements of psychology to improve emotional regulation, resilience and acceptance based coping. This mindfulness based intervention may reduce patient reported symptoms in patients with cGVHD.
Detailed description
PRIMARY OBJECTIVE:
- Assess the feasibility of an 8-week mindfulness-based intervention (MBI) program consisting of weekly group sessions and a practitioner/patient 1:1 session in patients with a diagnosis of chronic graft-versus-host disease (cGVHD).
SECONDARY OBJECTIVES:
- Determine the number of patients who withdraw consent before starting group sessions or do not attend any of the planned group sessions.
II. Assess the feasibility of daily self-meditation in patients with a diagnosis of cGVHD.
III. Estimate the preliminary efficacy of the MBI program in patients with cGVHD.
EXPLORATORY OBJECTIVE:
- Examine potential associations between the MBI program and the following at baseline, Week 4, and at completion of the MBI program.
OUTLINE:
Patients complete group sessions once weekly (QW), on weeks 1-4, over 40 minutes, and on weeks 6-8, over 60 minutes, and an individual session, over 60 minutes, on week 5. Sessions consist of instruction on diaphragmatic breathing, body scan, visualization, and individual mediation practice. Patients are recommended to complete self mediation daily for at least 15 minutes, for 8 weeks. Patients undergo blood sample collection throughout the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (mindfulness based intervention) | Experimental | Procedure: Biospecimen Collection, Behavioral: Mindfulness Relaxation, Other: Survey AdministrationPatients complete group sessions QW, on weeks 1-4, over 40 minutes, and on weeks 6-8, over 60 minutes, and an individual session, over 60 minutes, on week 5. Sessions consist of instruction on diaphragmatic breathing, body scan, visualization, and individual mediation practice. Patients are recommended to complete self mediation daily for at least 15 minutes, for 8 weeks. Patients undergo blood sample collection throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Documented informed consent of the participant and/or legally authorized representative
- Willingness to participate in the study
- Willingness to attend in-person or virtual group sessions
- Ability to read and understand English (required for protocol therapy and planned survey)
- Age: ≥ 18 years
Key exclusion criteria (5 listed)
- Previous participation in four or more sessions of mindfulness-based cognitive therapy (MBCT)/ mindfulness-based stress reduction (MBSR)
- An increase in anti-cGvHD medication (increased dosage or addition of a new medication) within 4 weeks prior to baseline evaluation
- Severe psychiatric comorbidities (active psychosis, suicidal ideation) as determined by primary investigator (PI)
- Concurrent malignancy, autoimmune disease, chronic infections, or other chronic inflammatory illness that might confound the results as determined by the PI
- Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
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 |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Supportive care (mindfulness based intervention) |
| Mindfulness RelaxationAlso: MBSR, Mindful Meditation, Mindfulness Meditation, Mindfulness-Based Stress ReductionComplete group mindfulness sessions | Behavioural | Supportive care (mindfulness based intervention) |
| Mindfulness RelaxationAlso: MBSR, Mindful Meditation, Mindfulness Meditation, Mindfulness-Based Stress ReductionComplete individual mindfulness session | Behavioural | Supportive care (mindfulness based intervention) |
| Mindfulness RelaxationAlso: MBSR, Mindful Meditation, Mindfulness Meditation, Mindfulness-Based Stress ReductionComplete daily self meditation | Behavioural | Supportive care (mindfulness based intervention) |
| Survey AdministrationAncillary studies | Other | Supportive care (mindfulness based intervention) |
Primary outcome
Compliance (feasibility)
Time frame: Up to 8 weeks
Feasibility is defined as 12 or more of 15 evaluable participants meet compliance criteria. Compliance for each participant will be a binary endpoint (yes versus no). If a participant completes 5/7 group sessions, the practitioner/patient 1:1 session, and end of treatment assessments, compliance is defined as yes. Will be summarized using the percentage and 90% confidence intervals.
4 secondary outcomes
Reason for not starting study activities after signing consent
Time frame: Up to 8 weeks
Feasibility of daily meditation in patients with a diagnosis of cGVHD
Time frame: Up to 8 weeks
Decrease of > 5 points on the 7-day Modified Lee Chronic Graft Versus Host Disease Symptom Scale (MLSS
Time frame: From baseline to completion of mindfulness based intervention (MBI) program, up to 8 weeks
Decrease in cGVHD severity stage per 2014 NIH consensus cGVHD grading criteria
Time frame: From baseline to completion of MBI program, up to 8 weeks
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 16 Oct 2026.
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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.
Amandeep Salhotra principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biospecimen Collection, Mindfulness Relaxation and Survey Administration in people with Chronic Graft Versus Host Disease and Hematopoietic and Lymphatic System Neoplasm, run by City of Hope Medical Center at 1 site in United States.
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 7 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance (feasibility) (time frame: Up to 8 weeks). 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 16 Oct 2026.