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NCT05294991 · ClinicalTrials.gov registry record · NA
Wellness App for Sleep Disturbance in Hematological Cancer Patients
A NA study of Depression and Cancer, sponsored by The University of Texas Health Science Center at San Antonio.
- Recruiting
- Registry status
- NA
- Development phase
- 276
- Enrollment target
- 3
- Study locations
NCT05294991 is a NA study of Depression and Cancer that is actively recruiting participants, run by The University of Texas Health Science Center at San Antonio. The registered enrollment target is 276 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (65% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT05294991, a NA study of Depression and Cancer, is actively recruiting participants, sponsored by The University of Texas Health Science Center at San Antonio.
- RECRUITING
- Registry status
- NA
- Development phase
- 276 participants
- Enrollment target
- 3
- Study locations
Study 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 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. Aim 1: Test the efficacy of two app-based wellness programs (10 minutes per day) on the primary outcome of self reported sleep disturbance (Insomnia Severity Index (primary) and PROMIS Sleep Disturbance (secondary)) and secondary sleep outcomes including sleep impairment (PROMIS Sleep Impairment Scale) and sleep efficiency measured via sleep diaries and actigraphy. Aim 2: Test the efficacy of two app-based wellness programs (10 minutes per day) on inflammatory markers (i.e., TNF-a, IL-6, IL-8, CRP), fatigue, and emotional distress (i.e., anxiety, depressive symptoms measured with PROMIS®). Aim 3: Explore the sustained effects (i.e., 20 weeks from baseline) of two app-based wellness programs (10 minutes per day) in CHC patients.
Conditions Studied
Interventions
- BEHAVIORAL Wellness app intervention #1
- BEHAVIORAL Wellness app intervention #2
Study Locations (3)
Arizona
- Arizona State University - Phoenix
North Carolina
- Wake Forest University School of Medicine - Winston-Salem
Texas
- Mays Cancer Center at The University of Texas Health Science Center at San Antonio - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 276 participants |
| Start Date | 2023-02-20 |
| Est. Completion | 2026-10-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05294991
The ClinicalTrials.gov registry entry for NCT05294991 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 276 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (65% lower). The listed sponsor is The University of Texas Health Science Center at San Antonio, which has 378 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions - of which Wellness app intervention #1 is the first listed.
NCT05294991 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Arizona, North Carolina, Texas.
Frequently Asked Questions
What is clinical trial NCT05294991 about?
NCT05294991 is a clinical study titled "Wellness App for Sleep Disturbance in Hematological Cancer Patients". 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 a...
What is the current status of trial NCT05294991?
This trial is currently recruiting. It is a NA study. The enrollment target is 276 participants. The study started on 2023-02-20. Estimated completion is 2026-10-31.
What conditions does trial NCT05294991 study?
This clinical trial studies the following conditions: Depression, Cancer, Anxiety, Inflammation, Fatigue.
What interventions are being tested in trial NCT05294991?
The interventions under investigation include: Wellness app intervention #1 (BEHAVIORAL), Wellness app intervention #2 (BEHAVIORAL).
Who is sponsoring clinical trial NCT05294991?
This trial is sponsored by The University of Texas Health Science Center at San Antonio, which has 378 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05294991 being conducted?
This trial has 3 study locations across Arizona, North Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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