Advance Care Planning, Family Caregiver, Meditation, Metastatic Cancer, Mindfulness, Palliative Care, Quality of Life, Supportive Care
Conditions
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.
Interventions
BEHAVIORALMindfulness
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.
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Participants are blind to study hypotheses.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 avoidant coping | Baseline, 6 weeks, and 10 weeks | Avoidant coping will be assessed using the Mini-MAC Cognitive Avoidance subscale |
| 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 anxiety | Baseline, 6 weeks, and 10 weeks | Anxiety will be assessed using the GAD-7 |
| 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 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 interpersonal closeness | Baseline, 6 weeks, and 10 weeks | Interpersonal closeness will be assessed using the Perceived Interpersonal Closeness Scale. |
| 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. |
| Distress Thermometer | Baseline, 6 weeks, and 10 weeks | Distress will be assessed using the Distress Thermometer. |
| 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 family communication | Baseline, 6 weeks, and 10 weeks | Family communication will be assessed using the Social Constraint Scale |
| 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). |
Countries
United States
Outcome results
None listed