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

Not Applicable

Recruiting

• Conditions: Hematopoietic Stem Cell Transplantation; Cancer
• Interventions: Behavioral: Yoga Sessions; Behavioral: Questionnaries; Behavioral: Interviews

• Registration Number: NCT05681026
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-12-15
• Study First Submitted QC: 2022-12-27
• Study First Posted: 2023-01-11
• Study Start: 2023-08-28
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-26
• Primary Completion: 2026-01-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Yoga Sessions	Interviews	Participants will take part in Yoga of gentle movements, breathing exercises, relaxation techniques, and meditation all tailored to the participant's needs.
Yoga Sessions	Yoga Sessions	Participants will take part in Yoga of gentle movements, breathing exercises, relaxation techniques, and meditation all tailored to the participant's needs.
Yoga Sessions	Questionnaries	Participants will take part in Yoga of gentle movements, breathing exercises, relaxation techniques, and meditation all tailored to the participant's needs.

Primary Outcome Measures

Name	Time	Method
Patient Health Questionnaire-8 (PHQ-8)	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

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States