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

Primary Purpose

Stage IV Gastrointestinal Cancer, Advanced Gynecological Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stop, Breathe & Think™
End of Life Planning Videos
Caregiver wellness videos
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stage IV Gastrointestinal Cancer focused on measuring caregiver, end of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

End of Life Care with Meditation

Meditation Only

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Repeated Measures ANCOVA Model (F-Statistic)
Estimation of effect of the intervention
Repeated Measures ANCOVA Model (F-Statistic)
Estimation of effect of the intervention

Secondary Outcome Measures

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

Full Information

First Posted
July 20, 2016
Last Updated
April 2, 2019
Sponsor
Case Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT02842047
Brief Title
The Mediating Effects of Decentering on Self-Management of Stress and End of Life Planning
Official Title
Self-Management of Stress in Caregivers of Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
March 9, 2018 (Actual)
Study Completion Date
March 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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. 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. 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. Describe the neural activity processes that are associated with increased self-management activities.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IV Gastrointestinal Cancer, Advanced Gynecological Cancer
Keywords
caregiver, end of life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
End of Life Care with Meditation
Arm Type
Experimental
Arm Description
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.
Arm Title
Meditation Only
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Stop, Breathe & Think™
Other Intervention Name(s)
meditation app
Intervention Description
online daily meditations delivered using smart phone or other computer based application
Intervention Type
Behavioral
Intervention Name(s)
End of Life Planning Videos
Other Intervention Name(s)
online videos
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Caregiver wellness videos
Intervention Description
Three videos, each 10 minutes in length which will be viewed over the study period. The videos will walk participants though general caregiver wellness.
Primary Outcome Measure Information:
Title
Repeated Measures ANCOVA Model (F-Statistic)
Description
Estimation of effect of the intervention
Time Frame
At 10 months
Title
Repeated Measures ANCOVA Model (F-Statistic)
Description
Estimation of effect of the intervention
Time Frame
At 1 month
Secondary Outcome Measure Information:
Title
Change in National Comprehensive Cancer Network (NCNN) Distress Thermometer Score
Description
Measure of caregiver distress
Time Frame
From baseline to up to 10 months
Title
Change in Degner's Decisional Control Scale
Description
Measure of decisional control
Time Frame
From baseline to up to 10 months
Title
Change in End of Life Value
Description
Measure of end of life values and focus of care
Time Frame
From baseline to up to 10 months
Title
Change in PROMIS-29 Scale
Description
Measure of caregiver anxiety
Time Frame
From baseline to up to 10 months
Title
Change in O'Connor's Decisional Regret Scale
Description
Measure of decisional regret
Time Frame
From baseline to up to 10 months
Title
Change in FAMCARE Scale
Description
Measure of satisfaction with end of life care
Time Frame
From baseline to up to 10 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Douglas, PhD, RN
Organizational Affiliation
Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32205788
Citation
Moore SM, Musil CM, Alder ML, Pignatiello G, Higgins P, Webel A, Wright KD. Building a Research Data Repository for Chronic Condition Self-Management Using Harmonized Data. Nurs Res. 2020 Jul/Aug;69(4):254-263. doi: 10.1097/NNR.0000000000000435.
Results Reference
derived

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

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