Hematopoietic Stem Cell TransplantationNCT05681026
Cultural Tailoring and Pilot Testing of an Inpatient Yoga Therapy Program for Cancer Patients Undergoing Hematopoietic Stem Cell Transplantation in India, Tanzania, and the United States
A study testing Yoga Sessions, Questionnaries and Interviews in people with Hematopoietic Stem Cell Transplantation and Cancer, run by M.D. Anderson Cancer Center at 3 sites in 3 countries.
Trial summary
To develop and measure the effects of a culturally sensitive yoga program for inpatients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic Stem Cell Transplantation, Cancer
- What is being tested?
- Yoga Sessions, Questionnaries and Interviews
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 28 Aug 2023to 31 Jan 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
- Cancer patients scheduled to undergo an autologous or allogeneic HSCT at MD Anderson, HCG, or MNH;
- Age 18 or older;
- English, Hindi, or Swahili speaking;
- Able to sign a written informed consent and be willing to follow protocol requirements.
Who cannot join
- Extreme mobility issues that preclude participating in the YT;
- Major thought disorders such as schizophrenia or uncontrolled bipolar disorder;
- HCT comorbidity score of 3 or higher, excluding cancer diagnoses
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Lorenzo Cohen, PHD, 713-745-4260, lcohen@mdanderson.org
Lorenzo Cohen, PHD
India1 site, 1 recruiting
- Recruiting
Swami Vivekananda Yoga Anusandhana Samsthana
Giddenahalli, Karnataka, 560105
Manjunath Sharma, PhD, +91-080-22639983, nkmsharma@svyasa.org
Manjunath Sharma, PhD
Tanzania1 site, 1 recruiting
- Recruiting
Muhimbili National Hospital
Dar es Salaam
Stella Rwezaula, MD, +255-22-2151367-9, starwezy@yahoo.com
Stella Rwezaula, MD
About this study
To develop and measure the effects of a culturally sensitive yoga program for inpatients
Read the detailed description
Primary Objective:
- To develop a culturally tailored yoga therapy (YT) program for HSCT patients. We will conduct semi-structured interviews with patients from each center to examine cultural norms, culturally sensitive language, and specific factors relevant to yoga and psychosocial support.
Secondary Objectives:
- To optimize the HSCT YT program using an iterative process. Fifteen patients from each center (or until thematic saturation based on exit interviews) will participate in the yoga program two weeks prior to the transplant and throughout the first 30 days of the HSCT. Sessions will be delivered in person, via telehealth (Zoom), or in combination.
- To examine the feasibility of adherence and follow-up completion. We will declare the intervention feasible if: (a) at least 50% of patients complete a minimum of 50% of the 12 YT sessions, and (b) at least 60% of participants complete follow-up measures at 2 months after transplant (± 7 days).
- Conditions
- Hematopoietic Stem Cell Transplantation, Cancer
- Being tested
- Yoga Sessions, Questionnaries, Interviews
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga SessionsBehavioural
Participants will have up to 12 sessions, 3 sessions per week starting two weeks before the transplant and throughout the first 30 days of your hospitalization.
QuestionnariesBehavioural
Participants will complete 4 questionnaires about any symptoms you may be having, any anxiety and/or depression you may be having, your quality of life, and your expectations about your treatment.
InterviewsBehavioural
Participants will have an exit interview last about 30-45 minutes. The interview will be conducted over the phone or remotely over Zoom, FaceTime, or other approved video call methods.). The interview will be audio and video recorded and transcribed (typed).
| Study group | Role | What they receive |
|---|---|---|
| Yoga Sessions | Experimental | Participants will take part in Yoga of gentle movements, breathing exercises, relaxation techniques, and meditation all tailored to the participant's needs. Receives: Behavioral: Yoga Sessions; Behavioral: Questionnaries; Behavioral: Interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire-8 (PHQ-8)
The PHQ-8 is a 8-item self-report questionnaire used to assess bother of depressive symptoms over the past 2 weeks. The PHQ-8 is a 8-item questionnaire to screen for degree of depressive symptoms scored on a 0-24 scale with higher scores indicating greater distress and impairment
Measured: through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start28 Aug 2023
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lorenzo Cohen, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05681026
- Sponsor's protocol ID
- 2022-0785
- Other IDs
- NCI-2022-10563, 3P30CA016672-46S3
- Status last verified
- Feb 2026
- First submitted
- 15 Dec 2022
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mallaiah S, Majumdar V, Mama SK, Olson AL, Daher M, Badgare Y, Kolar Srinivasrao N, Rwezaula S, Muhoka P, Rao R, Jadav S, Wagner R, Wilson A, Nandi Krishnamurthy M, Cohen L. Adapting Yoga Therapy to Meet the Needs of Inpatients Undergoing Hematopoietic Stem Cell Transplantation: Insights From an International, Multisite, Qualitative Study. JCO Glob Oncol. 2026 Mar;12(3):e2500567. doi: 10.1200/GO-25-00567. Epub 2026 Mar 6.
PubMed 41791008
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cultural Tailoring and Pilot Testing of an Inpatient Yoga Therapy Program for Cancer Patients Undergoing Hematopoietic Stem Cell Transplantation in India, Tanzania, and the United States
- ClinicalTrials.gov ID
- NCT05681026
- Acronym / sponsor ID
- 2022-0785
- Conditions
- Hematopoietic Stem Cell Transplantation, Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 28 Aug 2023 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 11 Jan 2023 (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.
To develop and measure the effects of a culturally sensitive yoga program for inpatients
Detailed description
Primary Objective:
- To develop a culturally tailored yoga therapy (YT) program for HSCT patients. We will conduct semi-structured interviews with patients from each center to examine cultural norms, culturally sensitive language, and specific factors relevant to yoga and psychosocial support.
Secondary Objectives:
- To optimize the HSCT YT program using an iterative process. Fifteen patients from each center (or until thematic saturation based on exit interviews) will participate in the yoga program two weeks prior to the transplant and throughout the first 30 days of the HSCT. Sessions will be delivered in person, via telehealth (Zoom), or in combination.
- To examine the feasibility of adherence and follow-up completion. We will declare the intervention feasible if: (a) at least 50% of patients complete a minimum of 50% of the 12 YT sessions, and (b) at least 60% of participants complete follow-up measures at 2 months after transplant (± 7 days).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Yoga Sessions | Experimental | Behavioral: Yoga Sessions, Behavioral: Questionnaries, Behavioral: InterviewsParticipants will take part in Yoga of gentle movements, breathing exercises, relaxation techniques, and meditation all tailored to the participant's needs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cancer patients scheduled to undergo an autologous or allogeneic HSCT at MD Anderson, HCG, or MNH;
- Age 18 or older;
- English, Hindi, or Swahili speaking;
- Able to sign a written informed consent and be willing to follow protocol requirements.
Key exclusion criteria (3 listed)
- Extreme mobility issues that preclude participating in the YT;
- Major thought disorders such as schizophrenia or uncontrolled bipolar disorder;
- HCT comorbidity score of 3 or higher, excluding cancer diagnoses
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 |
|---|---|---|
| Yoga SessionsParticipants will have up to 12 sessions, 3 sessions per week starting two weeks before the transplant and throughout the first 30 days of your hospitalization. | Behavioural | Yoga Sessions |
| QuestionnariesParticipants will complete 4 questionnaires about any symptoms you may be having, any anxiety and/or depression you may be having, your quality of life, and your expectations about your treatment. | Behavioural | Yoga Sessions |
| InterviewsParticipants will have an exit interview last about 30-45 minutes. The interview will be conducted over the phone or remotely over Zoom, FaceTime, or other approved video call methods.). The interview will be audio and video recorded and transcribed (typed). | Behavioural | Yoga Sessions |
Primary outcome
Patient Health Questionnaire-8 (PHQ-8)
Time frame: through study completion; an average of 1 year
The PHQ-8 is a 8-item self-report questionnaire used to assess bother of depressive symptoms over the past 2 weeks. The PHQ-8 is a 8-item questionnaire to screen for degree of depressive symptoms scored on a 0-24 scale with higher scores indicating greater distress and impairment
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 27 Feb 2026.
- Derived from this study: PubMed 41791008Mallaiah S, Majumdar V, Mama SK, Olson AL, Daher M, Badgare Y, Kolar Srinivasrao N, Rwezaula S, Muhoka P, Rao R, Jadav S, Wagner R, Wilson A, Nandi Krishnamurthy M, Cohen L. Adapting Yoga Therapy to Meet the Needs of Inpatients Undergoing Hematopoietic Stem Cell Transplantation: Insights From an International, Multisite, Qualitative Study. JCO Glob Oncol. 2026 Mar;12(3):e2500567. doi: 10.1200/GO-25-00567. Epub 2026 Mar 6.
- M D Anderson Cancer CenterLink provided by the sponsor.
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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.
Lorenzo Cohen, PHD principal investigator
M.D. Anderson Cancer Center
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga Sessions, Questionnaries and Interviews in people with Hematopoietic Stem Cell Transplantation and Cancer, run by M.D. Anderson Cancer Center at 3 sites in 3 countries.
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 4 inclusion and 3 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 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, India, Tanzania. 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?
Contact Lorenzo Cohen, PHD ((713) 745-4260, lcohen@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire-8 (PHQ-8) (time frame: through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05681026, which also lists 1 linked publication.
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 27 Feb 2026.