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NCT03078608 · ClinicalTrials.gov registry record · NA
POEM (Practice Of Embracing Each Moment) STUDY
A NA study, sponsored by Kaiser Permanente.
- Completed
- Registry status
- NA
- Development phase
- 128
- Enrollment target
NCT03078608: Completed NA study, sponsored by Kaiser Permanente.
NCT03078608 is a NA study that has completed, run by Kaiser Permanente. The registered enrollment target is 128 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03078608, a NA study, has completed, sponsored by Kaiser Permanente.
- COMPLETED
- Registry status
- NA
- Development phase
- 128 participants
- Enrollment target
Study Summary
A cancer diagnosis is extremely stressful, emotionally challenging, and often life-altering for both patients and their loved ones. Although more than one-third of patients experience distress, doctors are typically at a loss as to how to help patients and their families manage these emotional challenges. Mindfulness-based programs, including meditation, are offered at major medical centers in the US and have been found to help reduce stress and improve quality of life among cancer patients. However, these classes often require 30+ hours of in-person instruction over 8 weeks, which is neither practical nor feasible for patients undergoing chemotherapy due to side effects and scheduling conflicts. This study will test whether an 8-week mobile app-based mindfulness program is accepted and useful for patients who have recently received chemotherapy and their loved ones. It will also test whether it is feasible to randomize participants into three groups: intervention, active control (receiving progressive muscle relaxation through the same app) and a wait list control group (will receive the meditation intervention 8 weeks later), so that a future study can test whether mindfulness intervention can help reduce stress and improve quality of life. Because many Americans own smartphone or tablet, an app that can teach stress reduction techniques at home or at infusion clinics has great potential to address emotional needs that providers often cannot. The study will also include caregivers of patients who have recently received chemotherapy as research has shown that caregivers tend to show high levels of stress and depression and worse physical health compared to non-caregivers. The negative effects of caregiving are most pronounced in caregivers of patients with cancer. However, little support is directed to caregivers as most medical attention goes toward the patients. The patient-caregiver relationship may serve as a source of mutual support and a surrogate for commu
Primary Outcome
The Hospital Anxiety and Depression Scale (HADS) will be used to measure anxiety in patient-participants. This scale is frequently used to assess psychosocial outcomes in cancer patients. The HADS is a 14-item self-report measurement tool designed for use in medical outpatient settings to assess depression and anxiety. Each subscale is scored from 0 to 21, with higher scores indicating greater distress; 0-7 is generally considered "normal," 8-10 "mild," 11-14 "moderate," and 15-21 "severe" sympt
Interventions
- BEHAVIORAL Mindfulness meditation program (administered via mobile app)
- BEHAVIORAL Progressive muscle relaxation (via mobile app)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2017-10-24 |
| Est. Completion | 2018-11-08 |
| Phase | NA |
What the finished NCT03078608 record still lists
NCT03078608 is an interventional study that assigns participants to a tested intervention. The registered 128 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Mindfulness meditation program (administered via mobile app) is the first listed.
NCT03078608 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03078608 about?
NCT03078608 is a clinical study titled "POEM (Practice Of Embracing Each Moment) STUDY". A cancer diagnosis is extremely stressful, emotionally challenging, and often life-altering for both patients and their loved ones. Although more than one-third of patients experience distress, doctors are typically at a loss as to how to help patients and their families manage these emotional chall...
What is the current status of trial NCT03078608?
This trial is currently completed. It is a NA study. The enrollment target is 128 participants. The study started on 2017-10-24. Estimated completion is 2018-11-08.
What interventions are being tested in trial NCT03078608?
The interventions under investigation include: Mindfulness meditation program (administered via mobile app) (BEHAVIORAL), Progressive muscle relaxation (via mobile app) (BEHAVIORAL).
Who is sponsoring clinical trial NCT03078608?
This trial is sponsored by Kaiser Permanente, which has 294 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03078608's enrollment target sits among peer trials
128 744th of 2000 higher than 1,252 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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