The Mediating Effects of Decentering on Self-Management of Stress and End of Life Planning
NCT ID: NCT02842047
Last Updated: 2019-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2016-07-01
2018-03-09
Brief Summary
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Detailed Description
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1. Evaluate the short and longer-term effects of the end of life care with medication (EOL\_M) and meditation only (M\_Only) interventions on stress reduction and end of life (EOL) planning behaviors and determine if there are different effects between EOL\_M and M\_ Only interventions.
2. Evaluate the short-term and long-term effects of the intervention on caregiver distress, decisional regret, and EOL values and goals of care for treatment.
3. Evaluate the impact of decentering on the association between the interventions, self-management behaviors (stress reduction and EOL planning behaviors) and distress, anxiety, concordance between EOL values and goals of care for treatment, decisional regret and satisfaction with EOL care.
4. Describe the neural activity processes that are associated with increased self-management activities.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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End of Life Care with Meditation
The intervention has two content components: end of life planning education (using end of life planning videos) and strategies and kindness based meditation (using the Stop, Breathe \& Think™ app). The activities comprising these components work together to improve both analytic neural processing (e.g. improving knowledge about goal setting and EOL planning, learning self-monitoring of EOL values and goals of care, and self-regulation skills of monitoring symptoms of distress and anxiety) and emotional neural processing (e.g. teaching participants to experience the moment non-judgmentally and directing thoughts to think positive thoughts and feel positive feelings like kindness and compassion.
Stop, Breathe & Think™
online daily meditations delivered using smart phone or other computer based application
End of Life Planning Videos
Three videos, each 10 minutes in length which will be viewed over the study period. The videos will walk participants though key aspects of end of life planning.
Meditation Only
This arm has the single content component of kindness based meditation delivered by using the Stop, Breathe \& Think™ application. This group will also be instructed to view 3 caregiver wellness videos.
Stop, Breathe & Think™
online daily meditations delivered using smart phone or other computer based application
Caregiver wellness videos
Three videos, each 10 minutes in length which will be viewed over the study period. The videos will walk participants though general caregiver wellness.
Interventions
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Stop, Breathe & Think™
online daily meditations delivered using smart phone or other computer based application
End of Life Planning Videos
Three videos, each 10 minutes in length which will be viewed over the study period. The videos will walk participants though key aspects of end of life planning.
Caregiver wellness videos
Three videos, each 10 minutes in length which will be viewed over the study period. The videos will walk participants though general caregiver wellness.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* coming with the patient at the Seidman Comprehensive Cancer Center at University Hospitals Case Medical Center (UHCMC)
* have access to the internet and a computer, tablet, or smart phone, and
* speak and comprehend English.
Exclusion Criteria
* require psychotherapy within the last three months
* have a history of dementia, major neurological illness
* pregnant
* history of a medical condition or procedure that is contraindicated for functional magnetic resonance imaging (fMRI) scanning (i.e. cardiac pacemaker, sternal wires, or metal implants); and
* claustrophobia requiring anxiolytics or sedation; or
* expect to relocate from Northeast, Ohio within 2 months
18 Years
ALL
Yes
Sponsors
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Case Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Sara Douglas, PhD, RN
Role: PRINCIPAL_INVESTIGATOR
Case Comprehensive Cancer Center
Locations
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University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Countries
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References
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Moore SM, Musil CM, Alder ML, Pignatiello G, Higgins P, Webel A, Wright KD. Building a Research Data Repository for Chronic Condition Self-Management Using Harmonized Data. Nurs Res. 2020 Jul/Aug;69(4):254-263. doi: 10.1097/NNR.0000000000000435.
Other Identifiers
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CASE4815
Identifier Type: -
Identifier Source: org_study_id
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