NCT03257007

Mindfulness to Enhance Quality of Life and Support Advance Care Planning

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Mindfulness
• Meditation
• Metastatic Cancer
• Quality of Life
• Advance Care Planning
• Palliative Care
• Family Caregiver
• Supportive Care

Interventions

Type	Name	Description
BEHAVIORAL	Mindfulness	The Mindfulness intervention sessions are designed to cultivate present-moment awareness in everyday life to facilitate adaptive and non-reactive relating to thoughts, feelings, and bodily sensations. Participants will be provided with 10-20 minute audio recordings of each of 5 mindfulness practices covered in class, recorded in the facilitator's voice. Participants will be encouraged to practice mindfulness at home 10-20 minutes per day, 6 days per week. Participants will be provided with weekly diaries on which to record type and amount of home practice of mindfulness skills.

Timeline

• Start date: 2017-05-09
• Primary completion: 2017-12-11
• Completion: 2017-12-11
• First posted: 2017-08-22
• Last updated: 2020-08-12

Locations

1 site across 1 country: United States