NCT02842047

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

Self-Management of Stress in Caregivers of Cancer Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Stage IV Gastrointestinal Cancer
• Advanced Gynecological Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Stop, Breathe & Think™	online daily meditations delivered using smart phone or other computer based application
BEHAVIORAL	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.
BEHAVIORAL	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.

Timeline

• Start date: 2016-07-01
• Primary completion: 2018-03-09
• Completion: 2018-03-09
• First posted: 2016-07-22
• Last updated: 2019-04-04

Locations

1 site across 1 country: United States