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

February 24, 2026 updated by: M.D. Anderson Cancer Center
To develop and measure the effects of a culturally sensitive yoga program for inpatients

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Primary Objective:

1. 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:

  1. 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.
  2. 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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • India
    • Karnataka
      • Giddenahalli, Karnataka, India, 560105
        • Recruiting
        • Swami Vivekananda Yoga Anusandhana Samsthana
        • Contact:
        • Principal Investigator:
          • Manjunath Sharma, PhD
  • Tanzania
      • Dar es Salaam, Tanzania
        • Recruiting
        • Muhimbili National Hospital
        • Contact:
        • Principal Investigator:
          • Stella Rwezaula, MD
  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Lorenzo Cohen, PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Study Population

MD Anderson Cancer Center

Description

Inclusion Criteria:

  1. Cancer patients scheduled to undergo an autologous or allogeneic HSCT at MD Anderson, HCG, or MNH;
  2. Age 18 or older;
  3. English, Hindi, or Swahili speaking;
  4. Able to sign a written informed consent and be willing to follow protocol requirements.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Yoga Sessions
Participants will take part in Yoga of gentle movements, breathing exercises, relaxation techniques, and meditation all tailored to the participant's needs.
Behavioral: Questionnaries
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.
Behavioral: Interviews
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).
Behavioral: Yoga Sessions
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion; an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Lorenzo Cohen, PHD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2023

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

January 31, 2028

Study Registration Dates

First Submitted

December 15, 2022

First Submitted That Met QC Criteria

December 27, 2022

First Posted (Actual)

January 11, 2023

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-0785
  • NCI-2022-10563 (Other Identifier: NCI-CTRP Clinical Trials Registry)
  • 3P30CA016672-46S3 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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