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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05681026
• Other study ID #: 2022-0785
• Secondary ID: NCI-2022-105633P
• Status: Recruiting
• Phase: Phase 1
• Start date: August 28, 2023
• Est. completion date: January 31, 2026

Study information

• Verified date: March 2024
• Source: M.D. Anderson Cancer Center
• Contact: Lorenzo Cohen, PHD
• Phone: (713) 745-4260
• Email: lcohen[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 throughout the first 30 days of the HSCT. Sessions will be delivered in person, via telehealth (Zoom), or in combination. 2. 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 31, 2026
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Cancer patients scheduled to undergo an autologous or allogeneic HSCT at MD Anderson, HCG, or MNH;

2. A minimum of 30-day inpatient hospital stay;

3. Age 18 or older;

4. English, Hindi, or Swahili speaking;

5. Able to sign a written informed consent and be willing to follow protocol requirements.

Exclusion Criteria:

1. Extreme mobility issues that preclude participating in the YT;

2. Major thought disorders such as schizophrenia or uncontrolled bipolar disorder;

3. HCT comorbidity score of 3 or higher

Related Conditions & MeSH terms

• Cancer
• Hematopoietic Stem Cell Transplantation

Intervention

Behavioral:
• Yoga Sessions
Participants will have up to 12 sessions, 3 sessions per week, over the first 30 days of your hospitalization.
• 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.
• 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).

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   M D Anderson Cancer Center