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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-28

Study Completion Date

2026-01-31

Brief Summary

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

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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:

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).

Conditions

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Hematopoietic Stem Cell Transplantation Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Yoga Sessions

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

Group Type EXPERIMENTAL

Yoga Sessions

Intervention Type 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

Intervention Type 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

Intervention Type 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).

Interventions

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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.

Intervention Type 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.

Intervention Type 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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No