Clinical Trials Logo

Clinical Trial Summary

Specific aim #1: Assess feasibility (i.e., acceptability, practicality, demand, limited efficacy) of a home-based, online yoga intervention in patients following allogeneic stem cell transplant. Feasibility benchmarks will include: >70% satisfied with the intervention and >70% intending to continue participating in online yoga (i.e., acceptability); >70% of participants achieving an average of >42 min/week (70% of presceibed 60 min/week) of online yoga throughout the 12-week intervention (i.e., demand); >70% completing questionnaires across all four time points (i.e., practicality); at least small effect sizes of the intervention on physical function, fatigue, anxiety, sleep disturbance, social functioning, pain interference, depression, and quality of life as compared to a podcast control group (i.e., limited efficacy).


Clinical Trial Description

Online Yoga Group: The intervention will be 12-weeks in duration and will consist of a series of pre-approved online yoga classes (6 manufactured specifically for the cancer-afflicted patients instructed by Udaya yoga therapist, Jules Mitchell, MS). Patients will be asked to complete a minimum of 60 minutes per week of yoga practice with encouragement to do more if they can. All Udaya.com videos will include a proper warm-up, cool down, and closing mindfulness activity (i.e., message from yoga therapist, brief meditation, final relaxation). Qualified Udaya yoga instructors who collectively have over 200 years of training and experience will expertly instruct the online yoga classes. Participants will be instructed to view a safety handout (see yoga safety & modifications handout) before gaining access to the Udaya video library. Yoga therapist, Jules Mitchell and PIs Huberty and Palmer will pre-approve Udaya videos that are appropriate for this population.

A 12-week yoga prescription utilized in previous online yoga studies in MPN patients will be used in the proposed study for BMT patients. The 12-week yoga prescription was designed to be safe and progressive for cancer patients. During the intervention, all classes will offer alternative poses, modifications, and use of props (i.e., yoga blocks and straps) in the instance poses are difficult for the participant (i.e., painful, irregular, uneven breath) and to ensure safety. In addition to specific instruction regarding form and safety, the yoga therapist will provide descriptions of each video that includes tips and modifications to poses (e.g., set the knee on your yoga mat if this feels more comfortable for you). Additionally, patients will also receive a yoga modifications handout outlining the contraindicated yoga poses with modifications (see yoga safety & modifications handout). This handout will include an exercise warning for patients that experience dizziness, lightheadedness or faintness, excessive shortness of breath, chest pain, and that they need to stop the activity and contact their health care professional immediately if these symptoms are experienced.

The participants will access their yoga prescription on the Udaya.com website using their provided username and password (see instruction document). Participants will be asked to participate in a total of at least 60 minutes of yoga and keep a log of their participation utilizing a daily log available through a REDCap link (see yoga group weekly log). For the entire study, participants will record in their log each time they participate in yoga, the class in which they participated, how long they practiced (start and stop time), their perceived exertion, and their perceived mindfulness. Research staff will provide a weekly reminder email at the beginning of each week encouraging participation in their weekly yoga (see weekly reminder emails). We will ask that participants follow the yoga prescription, but if participants feel they want to deviate from the prescription they have the option to participate in any videos assigned in previous weeks or in any of the additional videos included each week in the prescription.

Podcast Control Group: The podcast control group will be asked to view 60 minutes per week of online podcast videos. The podcast videos will contain general cancer-related health education material. To match the online yoga group for time and attention, 60 minutes per week will be prescribed, however, participants will have the ability to view additional videos each week. Furthermore, participants will also track their podcast video viewing each week in a daily log (see podcast group weekly log) by recording each time they view a video, the video that they viewed, and how long they viewed the video. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03902210
Study type Interventional
Source Arizona State University
Contact
Status Completed
Phase N/A
Start date February 25, 2019
Completion date March 25, 2020

See also
  Status Clinical Trial Phase
Withdrawn NCT02451462 - Pilot Trial of Zoledronic Acid to Prevent Bone Loss in Hematopoietic Cell Transplant Recipients N/A
Completed NCT03654599 - Effects of Digital Stories Intervention on Psychosocial Well-being N/A
Active, not recruiting NCT04395222 - Tocilizumab for the Prevention of Graft Failure and GVHD in Haplo-Cord Transplantation Phase 2
Not yet recruiting NCT05603156 - A Study of Olverembatinib Combined With Inotuzumab Ozogamicin in the Treatment ph+ ALL With MRD Persistent Positive N/A
Completed NCT03530969 - Geriatric Communication Skills Training Program for Oncology Clinicians N/A
Recruiting NCT04115241 - Activity Levels in Bone Marrow Transplant Patients
Completed NCT00143780 - Pneumonia Vaccine in Bone Marrow Transplant Recipients: Usefulness of Donor Vaccination Phase 4
Completed NCT05662631 - Remote Monitoring and Home-based Health Care for Treatment of Bone Marrow Transplant Patients N/A
Completed NCT03028961 - Stanford Letter or Traditional Advance Directive in Advance Care Planning in Patients Undergoing Bone Marrow Transplant N/A
Completed NCT02575079 - Parafilm to Prevent CLABSI in Pediatric Patients Undergoing HCT N/A
Active, not recruiting NCT02665065 - Study of Iomab-B vs. Conventional Care in Older Subjects With Active, Relapsed or Refractory Acute Myeloid Leukemia Phase 3
Completed NCT01735565 - Neutrophil Extracellular Trap Formation in Patients Undergoing Bone Marrow Transplant N/A
Completed NCT04041219 - Use of Sublingual Tacrolimus in Adult Blood and Marrow Transplant Patients Phase 4
Not yet recruiting NCT06361173 - Spanish BMT4me Usability & Acceptability
Completed NCT03030248 - Vancomycin for C Difficile NAAT+/EIA- Hematology Oncology Patients Phase 2
Completed NCT00695123 - Screening for Subjects to Participate in Studies of Blood Disorders
Terminated NCT02057289 - A Pharmacokinetic Study of Pediatric Micafungin Prophylaxis Phase 1
Completed NCT04275830 - The Effects of Heart Rate Variability Biofeedback Training on Hematopoietic Cell Transplantation Patients N/A
Completed NCT03245788 - Effectiveness of Lay Navigators in Meeting Cancer Patients' Non-Clinical Needs: A Pilot Study N/A
Completed NCT03758911 - Perspectives on Bone Marrow Donors Who Donate for Their Parent