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

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Hematopoietic Stem Cell Transplantation; Cancer

Treatments: Behavioral: Yoga Sessions; Behavioral: Questionnaries; Behavioral: Interviews

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05681026

3P30CA016672-46S3 (U.S. NIH Grant/Contract)

NCI-2022-10563 (Other Identifier)

2022-0785

Details and patient eligibility

About

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

Full 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).

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Yoga Sessions

Experimental group

Description:

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

Treatment:

Behavioral: Interviews

Behavioral: Questionnaries

Behavioral: Yoga Sessions