The Mediating Effects of Decentering on Self-Management of Stress and End of Life Planning

Study Overview
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Brief Summary
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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.

Detailed Description
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Investigators will conduct a randomized trial pilot study to examine two arms of the intervention among 20 caregivers of patients with advanced cancer. Investigators will collect mixed methods data to describe changes in proximal and distal outcomes. Investigators have chosen the time points to capture neural and behavioral changes associated with the intervention and to capture end of life quality of life (QOL) for a majority of caregivers after death of their loved one. Investigators aim to: 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. 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. 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. Describe the neural activity processes that are associated with increased self-management activities.

Official Title
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Self-Management of Stress in Caregivers of Cancer Patients

Conditions
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Stage IV Gastrointestinal Cancer, Advanced Gynecological Cancer

Intervention / Treatment
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* Behavioral: Stop, Breathe & Think™
* Behavioral: End of Life Planning Videos
* Behavioral: Caregiver wellness videos


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: End of Life Care with Meditation<br>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. | Behavioral: Stop, Breathe & Think™<br>* online daily meditations delivered using smart phone or other computer based application<br>* Other names: meditation app;Behavioral: End of Life Planning Videos<br>* 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.<br>* Other names: online videos;|
| Active Comparator: Meditation Only<br>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. | Behavioral: Stop, Breathe & Think™<br>* online daily meditations delivered using smart phone or other computer based application<br>* Other names: meditation app;Behavioral: Caregiver wellness videos<br>* Three videos, each 10 minutes in length which will be viewed over the study period. The videos will walk participants though general caregiver wellness.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in National Comprehensive Cancer Network (NCNN) Distress Thermometer Score | Measure of caregiver distress | From baseline to up to 10 months | 
| Change in Degner's Decisional Control Scale | Measure of decisional control | From baseline to up to 10 months | 
| Change in End of Life Value | Measure of end of life values and focus of care | From baseline to up to 10 months | 
| Change in PROMIS-29 Scale | Measure of caregiver anxiety | From baseline to up to 10 months | 
| Change in O'Connor's Decisional Regret Scale | Measure of decisional regret | From baseline to up to 10 months | 
| Change in FAMCARE Scale | Measure of satisfaction with end of life care | From baseline to up to 10 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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caregiver, end of life