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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| End of Life Care with Meditation | Experimental | 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 & Thinkâ„¢ 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. |
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| Meditation Only | Active Comparator | This arm has the single content component of kindness based meditation delivered by using the Stop, Breathe & Thinkâ„¢ application. This group will also be instructed to view 3 caregiver wellness videos. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stop, Breathe & Thinkâ„¢ | Behavioral | online daily meditations delivered using smart phone or other computer based application |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sara Douglas, PhD, RN | Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32205788 | Derived | 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. |
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| End of Life Planning Videos | Behavioral | 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. |
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| Caregiver wellness videos | Behavioral | Three videos, each 10 minutes in length which will be viewed over the study period. The videos will walk participants though general caregiver wellness. |
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| 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 |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D003643 | Death |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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