Clinical trial NCT03902210: BMT Online Wellness Study
Official title: An Online Wellness Intervention for Bone Marrow Transplant Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Marrow Transplant
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
First posted: 2019-04-03
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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).

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* 1) have received a bone marrow transplant 6 months ago
* 2) have a cancer diagnosis
* 3) no active infections
* 4) platelet count \>50
* 5) answer "no" to all items on the Physical Activity Readiness Questionnaire (PAR-Q), or be willing to obtain a signed medical release from their physician in the case that a question is answered with a "yes"
* 6) have access to a desktop or laptop on a regular basis
* 7) have access to reliable internet
* 8) read and understand English
* 9) age 18 years or older
* 10) willing to be randomized to one of two groups

Exclusion Criteria:

* 1) Engagement in yoga in the past year
* 2) currently engage in ≥150 min/week of moderate-/vigorous-intensity physical activity on a weekly basis
* 3) have a history of syncope in last 2 months
* 4) have a history of recurrent falls (≥2 in 2 months)
* 5) Any planned change in pharmacologic intervention (i.e., new drug) during the study interval (i.e., 20 weeks)
* 6) have an Eastern Cooperative Oncology Group 3 (ECOG 3) questionnaire score greater than three
* 7) currently utilize Udaya.com
* 8) currently pregnant
* 9) currently reside outside of the United States of America

Primary outcomes:
measure: Physical Function
timeFrame: Change from baseline to midpoint (week 6), post-intervention (week 12), and follow-up (week 20)
measure: Anxiety
timeFrame: Change from baseline to midpoint (week 6), post-intervention (week 12), and follow-up (week 20)
measure: Depression
timeFrame: Change from baseline to midpoint (week 6), post-intervention (week 12), and follow-up (week 20)
measure: Fatigue
timeFrame: Change from baseline to midpoint (week 6), post-intervention (week 12), and follow-up (week 20)
measure: Sleep Disturbance
timeFrame: Change from baseline to midpoint (week 6), post-intervention (week 12), and follow-up (week 20)
measure: Ability to Participate in Social Roles and Activities
timeFrame: Change from baseline to midpoint (week 6), post-intervention (week 12), and follow-up (week 20)
measure: Pain Interference
timeFrame: Change from baseline to midpoint (week 6), post-intervention (week 12), and follow-up (week 20)
measure: Pain Intensity
timeFrame: Change from baseline to midpoint (week 6), post-intervention (week 12), and follow-up (week 20)
measure: Physical Health
timeFrame: Change from baseline to midpoint (week 6), post-intervention (week 12), and follow-up (week 20)
measure: Chronic Graft vs. Host Disease Symptoms
timeFrame: Change from baseline to midpoint (week 6), post-intervention (week 12), and follow-up (week 20)
measure: Mental Health
timeFrame: Change from baseline to midpoint (week 6), post-intervention (week 12), and follow-up (week 20)
Secondary outcomes:
measure: Objective Physical Activity
timeFrame: Daily physical activity throughout the 12-week intervention (baseline through week 12)
measure: Subjective Physical Activity
timeFrame: Weekly physical activity throughout the 12-week intervention (baseline through week 12)
measure: Objective Yoga/Podcast Participation
timeFrame: Weekly throughout the 12-week intervention (baseline through week 12)
measure: Subjective Yoga/Podcast Participation
timeFrame: Weekly throughout the 12-week intervention (baseline through week 12)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona State University
state: Arizona
Study officials:
affiliation: Arizona State University
name: Jennifer Huberty, Ph
role: PRINCIPAL_INVESTIGATOR
References: