Wellness app to improve sleep for cancer patients
Consumer-Based Meditation App, Calm, for Treatment of Sleep Disturbance in Hematological Cancer Patients
NA · The University of Texas Health Science Center at San Antonio · NCT05294991
This study is testing a wellness app to see if it can help cancer patients sleep better over eight weeks.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 276 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Texas Health Science Center at San Antonio (other) |
| Locations | 3 sites (Phoenix, Arizona and 2 other locations) |
| Trial ID | NCT05294991 on ClinicalTrials.gov |
What this trial studies
This clinical trial involves a randomized controlled trial where 276 patients with chronic hematological cancer will participate in an 8-week wellness app intervention aimed at improving sleep disturbances. Participants will use two different app-based wellness programs for 10 minutes daily, followed by a 12-week follow-up period. The study will assess the efficacy of these interventions on sleep quality and related outcomes using validated measures such as the Insomnia Severity Index and sleep diaries. The goal is to provide a non-pharmacologic solution to sleep issues commonly faced by these patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a self-declared diagnosis of chronic hematological cancer who experience sleep disturbances but do not have a formal sleep disorder diagnosis.
Not a fit: Patients currently undergoing allogenic stem cell transplantation or participating in other therapeutic pharmacologic clinical trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve sleep quality and overall well-being for patients with chronic hematological cancer.
How similar studies have performed: Previous studies have shown that mindfulness and meditation-based interventions can improve sleep disturbances in cancer patients, suggesting potential success for this novel approach in chronic hematological cancer patients.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Phoenix, Arizona and 2 other locations
- Arizona State University — Phoenix, Arizona, United States (ACTIVE_NOT_RECRUITING)
- Wake Forest University School of Medicine — Winston-Salem, North Carolina, United States (RECRUITING)
- Mays Cancer Center at The University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Jennifer Huberty, PhD — The University of Texas Health Science Center at San Antonio
- Study coordinator: Jillian Johnson, PhD
- Email: jillian.johnson@advocatehealth.org
- Phone: 814-424-5601
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cancer, Sleep Disturbance, Anxiety, Depression, Inflammation, Fatigue