Clinical trial NCT03257007: Mindfulness to Enhance Quality of Life and Support Advance Care Planning
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mindfulness
Meditation
Metastatic Cancer
Quality of Life
Advance Care Planning
Palliative Care
Family Caregiver
Supportive Care
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2017-08-22
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned in equal numbers using block randomization to the mindfulness intervention or usual care. The course curriculum for the mindfulness intervention 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 purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria-Patients

* Patient is at least 18 years of age.
* Patient is at least 3 weeks post-diagnosis of an incurable (locally advanced or metastatic) solid malignancy.
* Patient's attending medical oncologist would not be surprised if the patient died in the next 12 months.
* Patient has not completed a POST form.
* Patient scores ≥ 7 on the Mini-Mental Adjustment to Cancer cognitive avoidance subscale.
* Patient is willing and able to consent and travel to the class location for 6 weekly 2-hour sessions.
* Patient has a family member or close friend eligible and interested in participating in the study.
* Patient has adequate English fluency for completion of data collection

Inclusion Criteria-Family Care Givers (FCG)

* FCG is at least 18 years of age.
* FCG has been invited to participate in the trial with a patient who meets eligibility criteria above.
* FCG is willing and able to consent and travel to the class location for 6 weekly 2-hour sessions.
* FCG has adequate English fluency for completion of data collection

Exclusion Criteria-Patients

* Patient reports a score of \> 2 on the Activities and Function item from the Patient Generated Subjective Global Assessment91 (PG-SGA; the patient-reported version of the Eastern Cooperative Oncology Group score).
* Patient makes 3 or more errors on a validated 6-item cognitive screener or exhibits significant psychiatric or cognitive impairment (e.g., dementia/delirium, retardation, active psychosis) that in the judgment of the investigators would preclude providing informed consent and study participation.
* Currently receiving hospice care (patients who enroll in hospice during the trial will have the option of continuing trial participation).

Exclusion Criteria-FCGs

• FCG exhibits significant psychiatric or cognitive impairment (e.g., dementia/delirium, retardation, active psychosis) that in the judgment of the investigators would preclude providing informed consent and study participation.

Primary outcomes:
measure: Change from baseline in quality of life (QoL) for Patients
timeFrame: Baseline, 6 weeks, and 10 weeks
measure: Change from baseline in quality of life (QoL) for Family Caregivers
timeFrame: Baseline, 6 weeks, and 10 weeks
Secondary outcomes:
measure: Change from baseline in advance care planning (ACP) stage of change
timeFrame: Baseline, 6 weeks, and 10 weeks
measure: Change from baseline in advance care planning (ACP) engagement
timeFrame: Baseline, 6 weeks, and 10 weeks
measure: Change from baseline in caregiver burden
timeFrame: Baseline, 6 weeks, and 10 weeks
measure: Change from baseline in avoidant coping
timeFrame: Baseline, 6 weeks, and 10 weeks
measure: Change from baseline in avoidant coping
timeFrame: Baseline, 6 weeks, and 10 weeks
measure: Change from baseline in depressive symptoms
timeFrame: Baseline, 6 weeks, and 10 weeks
measure: Change from baseline in anxiety
timeFrame: Baseline, 6 weeks, and 10 weeks
measure: Change from baseline in spiritual well-being
timeFrame: Baseline, 6 weeks, and 10 weeks
measure: Change from baseline in sleep disturbance
timeFrame: Baseline, 6 weeks, and 10 weeks
measure: Change from baseline in family communication
timeFrame: Baseline, 6 weeks, and 10 weeks
measure: Change from baseline in interpersonal closeness
timeFrame: Baseline, 6 weeks, and 10 weeks
measure: Change from baseline in acceptance of illness
timeFrame: Baseline, 6 weeks, and 10 weeks
measure: Change from baseline in mindfulness
timeFrame: Baseline, 6 weeks, and 10 weeks
measure: Distress Thermometer
timeFrame: Baseline, 6 weeks, and 10 weeks
measure: Intervention satisfaction and helpfulness
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Shelley A Johns, PsyD
role: PRINCIPAL_INVESTIGATOR
References: