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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Change from baseline in quality of life (QoL) for Patients
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Participants are blind to study hypotheses.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Usual Care
Participants assigned to Usual Care will continue to receive standard care from their oncology team, including access to supportive care from oncology social workers. At the end of the study, usual care dyads will receive a packet of informational materials on mindfulness meditation, receive a CD with 5 mindfulness meditation practices, and meet with the study interventionist for guidance on how to use the materials and mindfulness recordings to their advantage in coping with cancer-related challenges.
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.
干预措施: Mindfulness (Behavioral)
结局指标
主要结局
Change from baseline in quality of life (QoL) for Patients
时间窗: 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
时间窗: Baseline, 6 weeks, and 10 weeks
QoL for family caregivers will be assessed with the Caregiver Quality of Life - Cancer scale (CQoLC).
次要结局
- Change from baseline in avoidant coping(Baseline, 6 weeks, and 10 weeks)
- Change from baseline in advance care planning (ACP) engagement(Baseline, 6 weeks, and 10 weeks)
- Change from baseline in family communication(Baseline, 6 weeks, and 10 weeks)
- Change from baseline in interpersonal closeness(Baseline, 6 weeks, and 10 weeks)
- Distress Thermometer(Baseline, 6 weeks, and 10 weeks)
- Change from baseline in caregiver burden(Baseline, 6 weeks, and 10 weeks)
- Change from baseline in advance care planning (ACP) stage of change(Baseline, 6 weeks, and 10 weeks)
- Change from baseline in anxiety(Baseline, 6 weeks, and 10 weeks)
- Intervention satisfaction and helpfulness(6 weeks)
- Change from baseline in depressive symptoms(Baseline, 6 weeks, and 10 weeks)
- Change from baseline in spiritual well-being(Baseline, 6 weeks, and 10 weeks)
- Change from baseline in sleep disturbance(Baseline, 6 weeks, and 10 weeks)
- Change from baseline in acceptance of illness(Baseline, 6 weeks, and 10 weeks)
- Change from baseline in mindfulness(Baseline, 6 weeks, and 10 weeks)
研究者
Shelley Johns
Assistant Professor of Medicine, Research Scientist
Indiana University