An interventional study of Stop, Breathe & Think™ and End of Life Planning Videos in Stage IV Gastrointestinal Cancer and Advanced Gynecological Cancer, sponsored by Case Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-04.
Sponsored by Case Comprehensive Cancer Center · Not applicable, Interventional, and Supportive care
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.
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:
795 studies on the registry are indexed under Gastrointestinal Neoplasms; 235 are open to participants now.
This study's enrollment of 20 is below the median of 60 across 580 interventional studies indexed under Gastrointestinal Neoplasms.
Browse Gastrointestinal Neoplasms studies →Case Comprehensive Cancer Center is the lead sponsor of 493 studies on the registry; 59 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 46 (61%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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™ · Behavioral: End of Life Planning Videos
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™ · Behavioral: Caregiver wellness videos
online daily meditations delivered using smart phone or other computer based application
Also known as: meditation app
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.
Also known as: online 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.
Repeated Measures ANCOVA Model (F-Statistic)
Estimation of effect of the intervention
Time frame: At 10 months
Repeated Measures ANCOVA Model (F-Statistic)
Estimation of effect of the intervention
Time frame: At 1 month
Change in National Comprehensive Cancer Network (NCNN) Distress Thermometer Score
Measure of caregiver distress
Time frame: From baseline to up to 10 months
Change in Degner's Decisional Control Scale
Measure of decisional control
Time frame: From baseline to up to 10 months
Change in End of Life Value
Measure of end of life values and focus of care
Time frame: From baseline to up to 10 months
Change in PROMIS-29 Scale
Measure of caregiver anxiety
Time frame: From baseline to up to 10 months
Change in O'Connor's Decisional Regret Scale
Measure of decisional regret
Time frame: From baseline to up to 10 months
Change in FAMCARE Scale
Measure of satisfaction with end of life care
Time frame: From baseline to up to 10 months
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Case Comprehensive Cancer Center →