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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02842047
Recruitment Status : Completed
First Posted : July 22, 2016
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Stage IV Gastrointestinal Cancer Advanced Gynecological Cancer Behavioral: Stop, Breathe & Think™ Behavioral: End of Life Planning Videos Behavioral: Caregiver wellness videos Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Self-Management of Stress in Caregivers of Cancer Patients
Actual Study Start Date : July 1, 2016
Actual Primary Completion Date : March 9, 2018
Actual Study Completion Date : March 9, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

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 Name: 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 Name: 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 Name: 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.




Primary Outcome Measures :
  1. Repeated Measures ANCOVA Model (F-Statistic) [ Time Frame: At 10 months ]
    Estimation of effect of the intervention

  2. Repeated Measures ANCOVA Model (F-Statistic) [ Time Frame: At 1 month ]
    Estimation of effect of the intervention


Secondary Outcome Measures :
  1. Change in National Comprehensive Cancer Network (NCNN) Distress Thermometer Score [ Time Frame: From baseline to up to 10 months ]
    Measure of caregiver distress

  2. Change in Degner's Decisional Control Scale [ Time Frame: From baseline to up to 10 months ]
    Measure of decisional control

  3. 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

  4. Change in PROMIS-29 Scale [ Time Frame: From baseline to up to 10 months ]
    Measure of caregiver anxiety

  5. Change in O'Connor's Decisional Regret Scale [ Time Frame: From baseline to up to 10 months ]
    Measure of decisional regret

  6. Change in FAMCARE Scale [ Time Frame: From baseline to up to 10 months ]
    Measure of satisfaction with end of life care



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842047


Locations
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United States, Ohio
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
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Principal Investigator: Sara Douglas, PhD, RN Case Comprehensive Cancer Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02842047    
Other Study ID Numbers: CASE4815
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Case Comprehensive Cancer Center:
caregiver
end of life
Additional relevant MeSH terms:
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Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases