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Official title Wellness App for Sleep Disturbance in Hematological Cancer Patients
ClinicalTrials.gov ID: NCT05294991
What this study is testing
- What it's testing
- 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 recruit a total of 276 self-declared Chronic Hematological Cancer (CHC) patients who (representative of age, race/ethnicity, and gender) will be on stable CHC pharmacologic therapy (if any), self-identify as sleep disturbed (\>5 on Pittsburgh Sleep Quality Index), do not have a sleep disorder diagnosis, do not take sleep medication/supplements \>3 times per week, and are not currently practicing regular meditation.
- Time commitment: about 5 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Self-declared diagnosis of hematological cancer on stable maintenance management\ by treating physician (i.e., on stable medical therapy) or...
- 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
You likely can't join if
- 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...
- Any other diagnosed and uncontrolled medical or psychiatric condition
See the full eligibility criteria
- 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...
- 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 assigned by chance
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Winston-Salem, North Carolina, United States
- San Antonio, Texas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Winston-Salem, North Carolina, United States; San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.