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

Case Comprehensive Cancer Center (Case CCC)

Status: Completed

Conditions: Stage IV Gastrointestinal Cancer; Advanced Gynecological Cancer

Treatments: Behavioral: Caregiver wellness videos; Behavioral: Stop, Breathe & Think™; Behavioral: End of Life Planning Videos

Study type: Interventional

Funder types: Other

Identifiers

NCT02842047

CASE4815

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

End of Life Care with Meditation

Experimental group

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.

Treatment:

Behavioral: End of Life Planning Videos

Behavioral: Stop, Breathe & Think™

Meditation Only

Active Comparator group

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.

Treatment:

Behavioral: Stop, Breathe & Think™

Behavioral: Caregiver wellness videos