Clinical trial NCT02842047: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stage IV Gastrointestinal Cancer
Advanced Gynecological Cancer
Keywords: caregiver
end of life
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2016-07-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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:

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.

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

Primary outcomes:
measure: Repeated Measures ANCOVA Model (F-Statistic)
timeFrame: At 10 months
measure: Repeated Measures ANCOVA Model (F-Statistic)
timeFrame: At 1 month
Secondary outcomes:
measure: Change in National Comprehensive Cancer Network (NCNN) Distress Thermometer Score
timeFrame: From baseline to up to 10 months
measure: Change in Degner's Decisional Control Scale
timeFrame: From baseline to up to 10 months
measure: Change in End of Life Value
timeFrame: From baseline to up to 10 months
measure: Change in PROMIS-29 Scale
timeFrame: From baseline to up to 10 months
measure: Change in O'Connor's Decisional Regret Scale
timeFrame: From baseline to up to 10 months
measure: Change in FAMCARE Scale
timeFrame: From baseline to up to 10 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Comprehensive Cancer Center
name: Sara Douglas, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
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.