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

Study Overview
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Brief Summary
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To develop and measure the effects of a culturally sensitive yoga program for inpatients

Detailed Description
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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: 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 throughout the first 30 days of the HSCT. Sessions will be delivered in person, via telehealth (Zoom), or in combination. To examine 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).

Official Title
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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

Conditions
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Hematopoietic Stem Cell Transplantation, Cancer

Intervention / Treatment
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* Behavioral: Yoga Sessions
* Behavioral: Questionnaries
* Behavioral: Interviews


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cancer patients scheduled to undergo an autologous or allogeneic HSCT at MD Anderson, HCG, or MNH; A minimum of 30-day inpatient hospital stay; 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga Sessions<br>Participants will take part in Yoga of gentle movements, breathing exercises, relaxation techniques, and meditation all tailored to the participant's needs. | Behavioral: Yoga Sessions<br>* Participants will have up to 12 sessions, 3 sessions per week, over the first 30 days of your hospitalization.<br>Behavioral: Questionnaries<br>* 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.<br>Behavioral: Interviews<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |