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Completed

NCT Number: NCT02842047

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Cleveland, Ohio, 44106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stop, Breathe & Think™

Behavioral

online daily meditations delivered using smart phone or other computer based application

Other names: meditation app

End of Life Planning Videos

Behavioral

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

Caregiver wellness videos

Behavioral

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Registry information

Official study title

Self-Management of Stress in Caregivers of Cancer Patients

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 22, 2016
Registry last updated
Apr 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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