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: 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
20
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.
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Repeated Measures ANCOVA Model (F-Statistic)
Estimation of effect of the intervention
Time frame: At 10 months
Repeated Measures ANCOVA Model (F-Statistic)
Estimation of effect of the intervention
Time frame: At 1 month
Change in National Comprehensive Cancer Network (NCNN) Distress Thermometer Score
Measure of caregiver distress
Time frame: From baseline to up to 10 months
Change in Degner's Decisional Control Scale
Measure of decisional control
Time frame: From baseline to up to 10 months
Change in End of Life Value
Measure of end of life values and focus of care
Time frame: From baseline to up to 10 months
Change in PROMIS-29 Scale
Measure of caregiver anxiety
Time frame: From baseline to up to 10 months
Change in O'Connor's Decisional Regret Scale
Measure of decisional regret
Time frame: From baseline to up to 10 months
Change in FAMCARE Scale
Measure of satisfaction with end of life care
Time frame: From baseline to up to 10 months
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