Status:
RECRUITING
Wellness App for Sleep Disturbance in Hematological Cancer Patients
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Collaborating Sponsors:
Arizona State University
Laboratory Corporation of America
Conditions:
Cancer
Sleep Disturbance
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In a randomized controlled trial (RCT), the investigators will recruit participants to an 8-week "app-based wellness" intervention, followed by a 12-week follow-up period. The investigators will recru...
Detailed Description
Background: Hematological cancers account for 11% of all cancer diagnoses in the US. Chronic hematological cancer (CHC) patients are characterized by long term and high symptom burden. Up to 65% of C...
Eligibility Criteria
Inclusion
- 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)
- Not currently participating in a therapeutic pharmacologic clinical trial
- Not planning to receive an allogenic stem cell transplantation during the study time frame (i.e., 20 weeks)
- Score of \>5 on PSQI (Pittsburgh Sleep Quality Index)
- Own a mobile smartphone (iPhone with iOS 14 or later or an Android 6 or later) with an active data or WiFi connection
- Willing to download two mobile apps
- Able to read/understand English
- ≥18 years of age
- Willing to be randomized
- 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)
- 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
- Self-report meditation practice or meditative movement practice (i.e., yoga, tai chi, qi gong) of ≥60 min/week in past 2 months
- Reside outside of the United States of America
- Any planned change to a new pharmacologic therapy (i.e., new drug) for the treatment of their cancer diagnosis (excluding dose changes)
- Diagnosed with a sleep disorder except insomnia (≥2 positive categories on Berlin Questionnaire)
- 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
- Any other diagnosed and uncontrolled medical or psychiatric condition
- Has a pacemaker
- Shift work schedule
Key Trial Info
Start Date :
February 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
276 Patients enrolled
Trial Details
Trial ID
NCT05294991
Start Date
February 20 2023
End Date
July 1 2026
Last Update
March 19 2025
Active Locations (3)
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1
Arizona State University
Phoenix, Arizona, United States, 85004
2
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27101
3
Mays Cancer Center at The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229