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

Advanced Gynecological Cancer Clinical Trial

Official title:

Self-Management of Stress in Caregivers of Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02842047
• Other study ID #: CASE4815
• Status: Completed
• Phase: N/A
• Start date: July 1, 2016
• Est. completion date: March 9, 2018

Study information

• Verified date: April 2019
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 9, 2018
• Est. primary completion date: March 9, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Gynecological Cancer
• Gastrointestinal Neoplasms
• Stage IV Gastrointestinal Cancer

Intervention

Behavioral:
• Stop, Breathe & Think™
online daily meditations delivered using smart phone or other computer based application
• 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.
• 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.

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Repeated Measures ANCOVA Model (F-Statistic)	Estimation of effect of the intervention	At 10 months
Primary	Repeated Measures ANCOVA Model (F-Statistic)	Estimation of effect of the intervention	At 1 month
Secondary	Change in National Comprehensive Cancer Network (NCNN) Distress Thermometer Score	Measure of caregiver distress	From baseline to up to 10 months
Secondary	Change in Degner's Decisional Control Scale	Measure of decisional control	From baseline to up to 10 months
Secondary	Change in End of Life Value	Measure of end of life values and focus of care	From baseline to up to 10 months
Secondary	Change in PROMIS-29 Scale	Measure of caregiver anxiety	From baseline to up to 10 months
Secondary	Change in O'Connor's Decisional Regret Scale	Measure of decisional regret	From baseline to up to 10 months
Secondary	Change in FAMCARE Scale	Measure of satisfaction with end of life care	From baseline to up to 10 months