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Trial 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
NCT ID:
NCT05681026
Condition:
Hematopoietic Stem Cell Transplantation
Cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Yoga Sessions
Description:
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.
Arm group label:
Yoga Sessions
Intervention type:
Behavioral
Intervention name:
Questionnaries
Description:
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.
Arm group label:
Yoga Sessions
Intervention type:
Behavioral
Intervention name:
Interviews
Description:
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).
Arm group label:
Yoga Sessions
Summary:
To develop and measure the effects of a culturally sensitive yoga program for inpatients
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).
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
M D Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lorenzo Cohen, PHD
Phone:
713-745-4260
Email:
lcohen@mdanderson.org
Investigator:
Last name:
Lorenzo Cohen, PHD
Email:
Principal Investigator
Start date:
August 28, 2023
Completion date:
January 31, 2026
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05681026
http://www.mdanderson.org
