NCT05681026

Brief Summary

To develop and measure the effects of a culturally sensitive yoga program for inpatients

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
21mo left

Started Aug 2023

Longer than P75 for not_applicable

Geographic Reach
3 countries

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Aug 2023Jan 2028

First Submitted

Initial submission to the registry

December 15, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 11, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

August 28, 2023

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2028

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

4.4 years

First QC Date

December 15, 2022

Last Update Submit

February 24, 2026

Conditions

CancerHematopoietic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (1)

  • 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

    through study completion; an average of 1 year

Study Arms (1)

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.

Behavioral: Yoga SessionsBehavioral: QuestionnariesBehavioral: Interviews

Interventions

QuestionnariesBEHAVIORAL

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.

Yoga Sessions
InterviewsBEHAVIORAL

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).

Yoga Sessions
Yoga SessionsBEHAVIORAL

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.

Yoga Sessions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Swami Vivekananda Yoga Anusandhana Samsthana

Giddenahalli, Karnataka, 560105, India

RECRUITING

Muhimbili National Hospital

Dar es Salaam, Tanzania

RECRUITING

Related Publications (1)

  • 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.

    PMID: 41791008DERIVED

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

Interviews as Topic

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Lorenzo Cohen, PHD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lorenzo Cohen, PHD

CONTACT

(713) 745-4260lcohen@mdanderson.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2022

First Posted

January 11, 2023

Study Start

August 28, 2023

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

January 31, 2028

Last Updated

February 27, 2026

Record last verified: 2026-02

Locations

IN(1)US(1)TA(1)