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

April 2, 2019 updated by: Case Comprehensive Cancer Center

Self-Management of Stress in Caregivers of Cancer Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: End of Life Care with Meditation
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 & Think™ 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.
Behavioral: Stop, Breathe & Think™
online daily meditations delivered using smart phone or other computer based application
Other Names:
  • meditation app
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.
Other Names:
  • online videos
Active Comparator: Meditation Only
This arm has the single content component of kindness based meditation delivered by using the Stop, Breathe & Think™ application. This group will also be instructed to view 3 caregiver wellness videos.
Behavioral: Stop, Breathe & Think™
online daily meditations delivered using smart phone or other computer based application
Other Names:
  • meditation app
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Repeated Measures ANCOVA Model (F-Statistic)
Time Frame: At 10 months
Estimation of effect of the intervention
At 10 months
Repeated Measures ANCOVA Model (F-Statistic)
Time Frame: At 1 month
Estimation of effect of the intervention
At 1 month

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Comprehensive Cancer Center

Investigators

  • Principal Investigator: Sara Douglas, PhD, RN, Case Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

March 9, 2018

Study Completion (Actual)

March 9, 2018

Study Registration Dates

First Submitted

July 20, 2016

First Submitted That Met QC Criteria

July 21, 2016

First Posted (Estimate)

July 22, 2016

Study Record Updates

Last Update Posted (Actual)

April 4, 2019

Last Update Submitted That Met QC Criteria

April 2, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CASE4815

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stage IV Gastrointestinal Cancer

Clinical Trials on Stop, Breathe & Think™

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe