Wellness App for Sleep Disturbance in Hematological Cancer Patients

Launched by THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO · Mar 15, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at the effectiveness of two wellness apps designed to help patients with hematological cancer who are struggling with sleep disturbances, anxiety, and fatigue. Over eight weeks, participants will use the app for just 10 minutes a day, and researchers will measure how this affects their sleep quality and emotional well-being. After the initial eight weeks, there will be a follow-up period of 12 weeks to see if the benefits continue.

To participate, individuals should be at least 18 years old, have a stable diagnosis of hematological cancer, and struggle with sleep (scoring above 5 on a sleep quality test). They should not be using sleep medications more than twice a week, should not be practicing meditation regularly, and must own a compatible smartphone. Participants will need to make three visits to a lab for blood tests during the study. This trial aims to provide valuable insights into how simple wellness tools can improve the quality of life for cancer patients dealing with sleep issues.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Self-declared diagnosis of hematological cancer on stable maintenance management\* by treating physician (i.e., on stable medical therapy) or observation (i.e., no changes in disease targeted medications for the past two weeks)
• • 2. Not currently participating in a therapeutic pharmacologic clinical trial
• • 3. Not planning to receive an allogenic stem cell transplantation during the study time frame (i.e., 20 weeks)
• • 4. Score of \>5 on PSQI (Pittsburgh Sleep Quality Index)
• • 5. Own a mobile smartphone (iPhone with iOS 14 or later or an Android 6 or later) with an active data or WiFi connection
• • 6. Willing to download two mobile apps
• • 7. Able to read/understand English
• • 8. ≥18 years of age
• • 9. Willing to be randomized
• • 10. Willing to drive to a nearby lab for blood draws 3x during the study over the course of 20 weeks (8-week intervention period followed by 12-week follow-up period)
• • 11. Taking sleep medications and/or over-the-counter sleep drugs/supplements (if any) on fewer than 3 nights per week and one of the following: 1) willing to maintain the same intake without change throughout the study time frame (i.e., 20 weeks) or 2) willing to discontinue if intake is prescribed "as needed" (PRN) by a physician throughout the study time frame (i.e., 20 weeks)
• Exclusion Criteria:
• • 1. Self-report meditation practice or meditative movement practice (i.e., yoga, tai chi, qi gong) of ≥60 min/week in past 2 months
• • 2. Reside outside of the United States of America
• • 3. Any planned change to a new pharmacologic therapy (i.e., new drug) for the treatment of their cancer diagnosis (excluding dose changes)
• • 4. Diagnosed with a sleep disorder except insomnia (≥2 positive categories on Berlin Questionnaire)
• • 5. Taking prescribed sleep medications and/or over-the-counter drugs/supplements (including drugs like NyQuil, Benadryl, and other antihistamine-based drugs) on ≥3 nights per week
• • 6. Any other diagnosed and uncontrolled medical or psychiatric condition
• • 7. Has a pacemaker
• • 8. Shift work schedule