Quality of Life Clinical Trial
Official title:
Mindfulness to Enhance Quality of Life and Support Advance Care Planning (MEANING): A Randomized Controlled Pilot Trial for Adults With Metastatic Cancer and Their Family Caregivers
The MEANING trial is a randomized controlled mixed methods pilot designed to compare a novel mindfulness meditation-based intervention (MEANING) to usual care for adults with advanced-stage solid malignancies and their family caregivers.
Mindfulness meditation practices have reduced emotional distress, avoidant coping, and
improved spiritual well-being in adult cancer patients. These beneficial effects may occur
through present-moment acceptance of unpleasant thoughts, feelings, and circumstances and
adaptive coping through self-awareness, self-regulation, and self-transcendence. Most
mindfulness trials in cancer have focused on early-stage survivors; however, preliminary
evidence suggests that mindfulness may help reduce distress in patients with advanced cancer
and their family caregivers (FCGs).
Sixty patients with an advanced-stage solid malignancy and their FCGs (60 dyads) will be
randomized in equal numbers to receive either the 6-week mindfulness intervention or usual
care. Both groups will receive standard cancer care throughout the study period. Dyads
randomized to the mindfulness arm will learn mindfulness meditation practices (e.g., body
scan, sitting meditation) and mindful communication practices to enhance quality of life,
support advance care planning engagement, and improve a variety of secondary outcomes.
The study will use a mixed methods 2-arm randomized design to examine the effects of the
mindfulness intervention compared to usual care and seek to explain trial results using
insights gleaned from post-intervention qualitative interviews.
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