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NCT04213872 · ClinicalTrials.gov registry record · NA
Gene Expression, Meditative Movement, and Emotional Distress (GME)
A NA study of Cognitive Impairment, sponsored by Arizona State University.
- Completed
- Registry status
- NA
- Development phase
- 27
- Enrollment target
- 1
- Study location
NCT04213872: Completed NA study of Cognitive Impairment, sponsored by Arizona State University.
NCT04213872 is a NA study of Cognitive Impairment that has completed, run by Arizona State University. The registered enrollment target is 27 participants, below the 665-participant average among 105 other Cognitive Impairment trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04213872, a NA study of Cognitive Impairment, has completed, sponsored by Arizona State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 27 participants
- Enrollment target
- 1
- Study location
Study Summary
Study Title: Gene Expression, Meditative Movement and Emotional Distress (GME) Background and Objectives: Breast cancer survivors (BCS) often report decrements in cognitive functioning. Cognitive impairment (CI) is generally understood as resulting from chemotherapy or radiation, but may also result from chronic emotional distress experienced by breast cancer patients and survivors. Meditation and exercise are both known to reduce stress, with growing evidence for the potential of each to also improve cognitive functioning in cancer patients and survivors. A Meditative Movement (MM) program (Qigong/Tai Chi Easy) offers the potential of combining both benefits of meditation and exercise for breast cancer survivors. This is a pilot study, testing the MM program to effect changes in cognitive functioning and associated symptoms/conditions such as anxiety, depression, sleep quality and using gene expression factors as biomarkers to potentially measure the molecular signature of these changes. Forty BCS will be consented and assigned to an intensive eight week MM program. Cognitive functioning and associated symptoms/conditions will be assessed before and after the 8-week MM program to examine the participants' behaviors and symptoms. Peripheral blood samples will be collected before and after the 8-week MM program and will be analyzed for gene expression changes. If successful, this study may provide preliminary data for a full powered randomized control trial if results show promise in the psycho-behavioral outcomes and genomic expression results.
Primary Outcome
Perceived Cognitive Impairments (CogPCI) is a patient self-report and validated subscale of the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-COG), 20 items. The range of values are 0-80 with lower scores signifying better outcomes.
Conditions Studied
Interventions
- BEHAVIORAL Meditative Movement
Study Locations (1)
California
- Robert and Beverly Lewis Family Cancer Care Center - Pomona
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2017-07-17 |
| Est. Completion | 2020-09-15 |
| Phase | NA |
What the finished NCT04213872 record still lists
NCT04213872 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 665-participant average among 105 other Cognitive Impairment trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Cognitive Impairment appearing as the primary indexed condition, and to 1 intervention - of which Meditative Movement is the first listed.
NCT04213872 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04213872 about?
NCT04213872 is a clinical study titled "Gene Expression, Meditative Movement, and Emotional Distress (GME)". Study Title: Gene Expression, Meditative Movement and Emotional Distress (GME) Background and Objectives: Breast cancer survivors (BCS) often report decrements in cognitive functioning. Cognitive impairment (CI) is generally understood as resulting from chemotherapy or radiation, but may also resu...
What is the current status of trial NCT04213872?
This trial is currently completed. It is a NA study. The enrollment target is 27 participants. The study started on 2017-07-17. Estimated completion is 2020-09-15.
What conditions does trial NCT04213872 study?
This clinical trial studies the following conditions: Cognitive Impairment.
What interventions are being tested in trial NCT04213872?
The interventions under investigation include: Meditative Movement (BEHAVIORAL).
Who is sponsoring clinical trial NCT04213872?
This trial is sponsored by Arizona State University, which has 187 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04213872 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04213872's enrollment target sits among peer trials
27 87th of 105 higher than 18 of 105 other Cognitive Impairment trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cognitive Impairment 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.
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