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

Not Applicable

Completed

• Conditions: Advanced Gynecological Cancer; Stage IV Gastrointestinal Cancer

• Registration Number: NCT02842047
• Lead Sponsor: Case Comprehensive Cancer Center

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.

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.

Study Timeline

• Study Start: 2016-07-01
• Study First Submitted: 2016-07-20
• Study First Submitted QC: 2016-07-21
• Study First Posted: 2016-07-22
• Primary Completion: 2018-03-09
• Study Completion: 2018-03-09
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-02
• Last Update Posted: 2019-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Repeated Measures ANCOVA Model (F-Statistic)	At 1 month	Estimation of effect of the intervention

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States