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

Обзор

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

Подробное описание

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).

Вмешательства

• Поведенческое 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.
• Поведенческое 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.
• Поведенческое 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).

Первичные конечные точки

• Patient Health Questionnaire-8 (PHQ-8) [Срок оценки: through study completion; an average of 1 year]

Критерии участия

Критерии включения

• Cancer patients scheduled to undergo an autologous or allogeneic HSCT at MD Anderson, HCG, or MNH;
• Age 18 or older;
• English, Hindi, or Swahili speaking;
• Able to sign a written informed consent and be willing to follow protocol requirements.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• M D Anderson Cancer Center — Houston

Индия · 1 центр

• Swami Vivekananda Yoga Anusandhana Samsthana — Giddenahalli

Tanzania · 1 центр

• Muhimbili National Hospital — Dar es Salaam

Публикации

• Mallaiah S, Majumdar V, Mama SK, Olson AL, Daher M, Badgare Y, Kolar Srinivasrao N, Rwezaula S, Muhoka P, Rao R, Jadav S, Wagner R, Wilson A, Nandi Krishnamurthy M, Cohen L. Adapting Yoga Therapy to Meet the Needs of Inpatients Undergoing Hematopoietic Stem Cell Transplantation: Insights From an International, Multisite, Qualitative Study. JCO Glob Oncol. 2026 Mar;12(3):e2500567. doi: 10.1200/GO-2 PMID 41791008

Идентификаторы

NCT: NCT05681026 · 2022-0785 · NCI-2022-10563 · 3P30CA016672-46S3

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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