Advanced Gynecological Cancer, Stage IV Gastrointestinal Cancer
Conditions
Keywords
caregiver, end of life
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.
Interventions
BEHAVIORALStop, Breathe & Think™
online daily meditations delivered using smart phone or other computer based application
BEHAVIORALEnd 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.
BEHAVIORALCaregiver 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.
Sponsors
Case Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Repeated Measures ANCOVA Model (F-Statistic) | At 10 months | Estimation of effect of the intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Degner's Decisional Control Scale | From baseline to up to 10 months | Measure of decisional control |
| Change in End of Life Value | From baseline to up to 10 months | Measure of end of life values and focus of care |
| Change in National Comprehensive Cancer Network (NCNN) Distress Thermometer Score | From baseline to up to 10 months | Measure of caregiver distress |
| Change in O'Connor's Decisional Regret Scale | From baseline to up to 10 months | Measure of decisional regret |
| Change in FAMCARE Scale | From baseline to up to 10 months | Measure of satisfaction with end of life care |
| Change in PROMIS-29 Scale | From baseline to up to 10 months | Measure of caregiver anxiety |
Countries
United States
Outcome results
None listed