The Mediating Effects of Decentering on Self-Management of Stress and End of Life Planning
Self-Management of Stress in Caregivers of Cancer Patients
1 other identifier
interventional
20
1 country
1
Brief Summary
Caregivers of persons with cancer may face many challenges as they support and care for a person receiving treatment. Sometimes having to help make treatment decisions for a patient can cause distress for caregivers. The purpose of this study is to evaluate 2 different electronic approaches to providing support for a caregiver. One group will have access to an on-line program with videos, providing education on decision making strategies for caregivers of patients with cancer, to watch and a daily meditation application and the other group will have access to the daily meditation application. Investigators will randomly assign participants to each group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 20, 2016
CompletedFirst Posted
Study publicly available on registry
July 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 9, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 9, 2018
CompletedApril 4, 2019
April 1, 2019
1.7 years
July 20, 2016
April 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Repeated Measures ANCOVA Model (F-Statistic)
Estimation of effect of the intervention
At 10 months
Repeated Measures ANCOVA Model (F-Statistic)
Estimation of effect of the intervention
At 1 month
Secondary Outcomes (6)
Change in National Comprehensive Cancer Network (NCNN) Distress Thermometer Score
From baseline to up to 10 months
Change in Degner's Decisional Control Scale
From baseline to up to 10 months
Change in End of Life Value
From baseline to up to 10 months
Change in PROMIS-29 Scale
From baseline to up to 10 months
Change in O'Connor's Decisional Regret Scale
From baseline to up to 10 months
- +1 more secondary outcomes
Study Arms (2)
End of Life Care with Meditation
EXPERIMENTALThe 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.
Meditation Only
ACTIVE COMPARATORThis 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.
Interventions
online daily meditations delivered using smart phone or other computer based application
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.
Three videos, each 10 minutes in length which will be viewed over the study period. The videos will walk participants though general caregiver wellness.
Eligibility Criteria
You may qualify if:
- caregivers of patients who have been diagnosed with Stage IV gastrointestinal (GI) cancer
- 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.
You may not qualify if:
- currently practicing mindfulness-based interventions (yoga, meditation, deep breathing)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106, United States
Related Publications (1)
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.
PMID: 32205788DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sara Douglas, PhD, RN
Case Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2016
First Posted
July 22, 2016
Study Start
July 1, 2016
Primary Completion
March 9, 2018
Study Completion
March 9, 2018
Last Updated
April 4, 2019
Record last verified: 2019-04