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NCT Number: NCT05681026

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Swami Vivekananda Yoga Anusandhana Samsthana, Giddenahalli, Karnataka, India

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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

Treatment and study plan

Yoga Sessions

Behavioral

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.

Questionnaries

Behavioral

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.

Interviews

Behavioral

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).

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Lorenzo Cohen, PHD

CONTACT

[email protected]

(713) 745-4260

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jan 11, 2023
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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