Mindfulness to Enhance Quality of Life and Support Advance Care Planning

Not Applicable

Completed

• Conditions: Advance Care Planning; Palliative Care; Supportive Care; Mindfulness; Meditation; Metastatic Cancer; Quality of Life; Family Caregiver
• Interventions: Behavioral: Mindfulness

• Registration Number: NCT03257007
• Lead Sponsor: Indiana University

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-05-09
• Study First Submitted: 2017-08-16
• Study First Submitted QC: 2017-08-17
• Study First Posted: 2017-08-22
• Primary Completion: 2017-12-11
• Study Completion: 2017-12-11
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-10
• Last Update Posted: 2020-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness	Mindfulness	The Mindfulness intervention will consist of six 2-hour sessions that will include guided mindfulness practices, didactics, and group discussion. The course curriculum is modeled on the Mindfulness-Based Stress Reduction program which involves intensive experiential training of participants in secular mindfulness meditation practices (i.e., body scan, sitting meditation, gentle hatha yoga with chair adaptations, compassion meditation), with an emphasis on embodying interpersonal mindfulness in dialogue.

Primary Outcome Measures

Name	Time	Method
Change from baseline in quality of life (QoL) for Patients	Baseline, 6 weeks, and 10 weeks	QoL for patients will be assessed with the McGill Quality of Life Inventory.
Change from baseline in quality of life (QoL) for Family Caregivers	Baseline, 6 weeks, and 10 weeks	QoL for family caregivers will be assessed with the Caregiver Quality of Life - Cancer scale (CQoLC).

Secondary Outcome Measures

Name	Time	Method
Change from baseline in advance care planning (ACP) engagement	Baseline, 6 weeks, and 10 weeks	ACP engagement (self-efficacy, readiness) will be measured using 2 subscales of the Advance Care Planning Engagement Survey (patient only measure).
Change from baseline in family communication	Baseline, 6 weeks, and 10 weeks	Family communication will be assessed using the Social Constraint Scale
Change from baseline in caregiver burden	Baseline, 6 weeks, and 10 weeks	Caregiver burden will be measured using the Zarit Burden Interview (family caregiver measure only)
Change from baseline in advance care planning (ACP) stage of change	Baseline, 6 weeks, and 10 weeks	ACP stage of change will be assessed by a measure modified from Fried et. al assessing stage of change for 3 advance care planning behaviors (completing a living will, medical power of attorney form, or POLST form; patient only measure).
Change from baseline in anxiety	Baseline, 6 weeks, and 10 weeks	Anxiety will be assessed using the GAD-7
Intervention satisfaction and helpfulness	6 weeks	Satisfaction and helpfulness with the Mindfulness intervention will be assessed using single-item investigator-created 7- and 10-point Likert scales, respectively (Mindfulness group only).
Change from baseline in avoidant coping	Baseline, 6 weeks, and 10 weeks	Avoidant coping will be assessed using the Brief COPE Self-Distraction, Denial, and Behavioral Disengagement subscales
Change from baseline in depressive symptoms	Baseline, 6 weeks, and 10 weeks	Depressive symptoms will be assessed using the PHQ-8
Change from baseline in spiritual well-being	Baseline, 6 weeks, and 10 weeks	Spiritual well-being will be measured using the FACIT-SP.
Change from baseline in sleep disturbance	Baseline, 6 weeks, and 10 weeks	Sleep disturbance will be assessed using the PROMIS Sleep Disturbance.
Change from baseline in acceptance of illness	Baseline, 6 weeks, and 10 weeks	Acceptance of illness will be assessed using the PEACE Scale.
Change from baseline in mindfulness	Baseline, 6 weeks, and 10 weeks	Mindfulness will be assessed using the FFMQ-SF Non-reactivity to Internal Experience and Acting with Awareness subscales.
Change from baseline in interpersonal closeness	Baseline, 6 weeks, and 10 weeks	Interpersonal closeness will be assessed using the Perceived Interpersonal Closeness Scale.
Distress Thermometer	Baseline, 6 weeks, and 10 weeks	Distress will be assessed using the Distress Thermometer.

Trial Locations

Locations (1)

Indiana University; 🇺🇸 Indianapolis, Indiana, United States