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NCT05681026 | RECRUITING | Hematopoietic Stem Cell Transplantation

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
Sponsor:

M.D. Anderson Cancer Center

Brief Summary:

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

Condition or disease

Hematopoietic Stem Cell Transplantation

Cancer

Intervention/treatment

Yoga Sessions

Questionnaries

Interviews

Phase

NA

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 Type : INTERVENTIONAL
Estimated Enrollment : 60 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : 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
Actual Study Start Date : 2023-08-28
Estimated Primary Completion Date : 2026-01-31
Estimated Study Completion Date : 2026-01-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
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

Location Details

NCT05681026

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Locations

RECRUITING

United States, Texas

M D Anderson Cancer Center

Houston, Texas, United States, 77030