Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05681026
Enrollment
60
Registered
2023-01-11
Start date
2023-08-28
Completion date
2028-01-31
Last updated
2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematopoietic Stem Cell Transplantation, Cancer

Brief 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).

Interventions

BEHAVIORALYoga 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.

BEHAVIORALQuestionnaries

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.

BEHAVIORALInterviews

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).

Sponsors

M.D. Anderson Cancer Center
Lead SponsorOTHER
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Patient Health Questionnaire-8 (PHQ-8)through study completion; an average of 1 yearThe 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

Countries

India, Tanzania, United States

Contacts

CONTACTLorenzo Cohen, PHD
lcohen@mdanderson.org(713) 745-4260
PRINCIPAL_INVESTIGATORLorenzo Cohen, PHD

M.D. Anderson Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026