BMT Online Wellness Study

NCT03902210 | Completed

• 1 other identifier: STUDY00009352
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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).

Conditions

Bone Marrow Transplant

Outcome Measures

Primary Outcomes (11)

• Physical Function

  This measure is captured through the PROMIS-29 Physical Function Subscale. Raw scores can range from 4-20, with higher scores indicating better physical function.

  Change from baseline to midpoint (week 6), post-intervention (week 12), and follow-up (week 20)

• Anxiety

  This measure is captured through the PROMIS-29 Anxiety Subscale. Raw scores range from 4-20, with higher scores indicating more anxiety.

  Change from baseline to midpoint (week 6), post-intervention (week 12), and follow-up (week 20)

• Depression

  This measure is captured through the PROMIS-29 Depression Subscale. Raw scores range from 4-20, with higher scores indicating more depression.

  Change from baseline to midpoint (week 6), post-intervention (week 12), and follow-up (week 20)

• Fatigue

  This measure is captured through the PROMIS-29 Fatigue Subscale. Raw scores range from 4-20, with higher scores indicating more fatigue.

  Change from baseline to midpoint (week 6), post-intervention (week 12), and follow-up (week 20)

• Sleep Disturbance

  This measure is captured through the PROMIS-29 Sleep Disturbance Subscale. Raw scores range from 4-20, with higher scores indicating more sleep disturbance.

  Change from baseline to midpoint (week 6), post-intervention (week 12), and follow-up (week 20)

• Ability to Participate in Social Roles and Activities

  This measure is captured through the PROMIS-29 Ability to Participate in Social Roles and Activities Subscale. Raw scores range from 4-20, with higher scores indicating a better ability to participate in social roles and activities.

  Change from baseline to midpoint (week 6), post-intervention (week 12), and follow-up (week 20)

• Pain Interference

  This measure is captured through the PROMIS-29 Pain Interference Subscale. Raw scores range from 4-20, with higher scores indicating more interference of pain in daily life.

  Change from baseline to midpoint (week 6), post-intervention (week 12), and follow-up (week 20)

• Pain Intensity

  This measure is captured through the PROMIS-29 Pain Intensity Subscale. This is a single-item question asking the participant to rate their average level of pain on a 0-10 scale, with a higher score indicating worse pain.

  Change from baseline to midpoint (week 6), post-intervention (week 12), and follow-up (week 20)

• Physical Health

  This measure is captured through the PROMIS Global Health Physical Subscale. Raw scores range from 2-10, with higher scores indicating better physical health.

  Change from baseline to midpoint (week 6), post-intervention (week 12), and follow-up (week 20)

• Chronic Graft vs. Host Disease Symptoms

  This measure is captured with the Lee Symptom Score, which assesses various symptoms commonly associated with Graft vs. Host Disease. Raw scores range from 0-120, with higher scores indicating higher symptom burden.

  Change from baseline to midpoint (week 6), post-intervention (week 12), and follow-up (week 20)

• Mental Health

  This measure is captured through the PROMIS Global Health Mental Health Subscale. Raw scores range from 2-10, with higher scores indicating better mental health.

  Change from baseline to midpoint (week 6), post-intervention (week 12), and follow-up (week 20)

Secondary Outcomes (4)

• Objective Physical Activity

  Daily physical activity throughout the 12-week intervention (baseline through week 12)

• Subjective Physical Activity

  Weekly physical activity throughout the 12-week intervention (baseline through week 12)

• Objective Yoga/Podcast Participation

  Weekly throughout the 12-week intervention (baseline through week 12)

• Subjective Yoga/Podcast Participation

  Weekly throughout the 12-week intervention (baseline through week 12)

Study Arms (2)

Online Yoga

EXPERIMENTAL

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.

Behavioral: Online Yoga

Podcast

PLACEBO COMPARATOR

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.

Behavioral: Podcast

Interventions

Online Yoga BEHAVIORAL

60 minutes per week of online yoga through Udaya.com

Online Yoga

Podcast BEHAVIORAL

60 minutes per week of podcasts

Podcast

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) have received a bone marrow transplant 6 months ago
• \) have a cancer diagnosis
• \) no active infections
• \) platelet count \>50
• \) 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"
• \) have access to a desktop or laptop on a regular basis
• \) have access to reliable internet
• \) read and understand English
• \) age 18 years or older
• \) willing to be randomized to one of two groups

You may not qualify if:

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

Sponsors & Collaborators

• Arizona State University: lead
• Mayo Clinic: collaborator

Study Sites (1)

Arizona State University

Phoenix, Arizona, 86004, United States

Location

Study Officials

• Jennifer Huberty, Ph

  Arizona State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 28, 2019
• First Posted: April 3, 2019
• Study Start: February 25, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 25, 2020
• Last Updated: March 27, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)