Mindfulness to Enhance Quality of Life and Support Advance Care Planning (MEANING)
2020年8月10日 更新者：Shelley Johns、Indiana University
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
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
108
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Indiana
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Indianapolis、Indiana、美国、46202
- Indiana University
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预：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.
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有源比较器：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.
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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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Change from baseline in quality of life (QoL) for Patients
大体时间：Baseline, 6 weeks, and 10 weeks
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QoL for patients will be assessed with the McGill Quality of Life Inventory.
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Baseline, 6 weeks, and 10 weeks
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Change from baseline in quality of life (QoL) for Family Caregivers
大体时间：Baseline, 6 weeks, and 10 weeks
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QoL for family caregivers will be assessed with the Caregiver Quality of Life - Cancer scale (CQoLC).
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Baseline, 6 weeks, and 10 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Change from baseline in advance care planning (ACP) stage of change
大体时间：Baseline, 6 weeks, and 10 weeks
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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).
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Baseline, 6 weeks, and 10 weeks
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Change from baseline in advance care planning (ACP) engagement
大体时间：Baseline, 6 weeks, and 10 weeks
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ACP engagement (self-efficacy, readiness) will be measured using 2 subscales of the Advance Care Planning Engagement Survey (patient only measure).
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Baseline, 6 weeks, and 10 weeks
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Change from baseline in caregiver burden
大体时间：Baseline, 6 weeks, and 10 weeks
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Caregiver burden will be measured using the Zarit Burden Interview (family caregiver measure only)
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Baseline, 6 weeks, and 10 weeks
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Change from baseline in avoidant coping
大体时间：Baseline, 6 weeks, and 10 weeks
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Avoidant coping will be assessed using the Mini-MAC Cognitive Avoidance subscale
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Baseline, 6 weeks, and 10 weeks
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Change from baseline in avoidant coping
大体时间：Baseline, 6 weeks, and 10 weeks
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Avoidant coping will be assessed using the Brief COPE Self-Distraction, Denial, and Behavioral Disengagement subscales
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Baseline, 6 weeks, and 10 weeks
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Change from baseline in depressive symptoms
大体时间：Baseline, 6 weeks, and 10 weeks
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Depressive symptoms will be assessed using the PHQ-8
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Baseline, 6 weeks, and 10 weeks
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Change from baseline in anxiety
大体时间：Baseline, 6 weeks, and 10 weeks
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Anxiety will be assessed using the GAD-7
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Baseline, 6 weeks, and 10 weeks
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Change from baseline in spiritual well-being
大体时间：Baseline, 6 weeks, and 10 weeks
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Spiritual well-being will be measured using the FACIT-SP.
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Baseline, 6 weeks, and 10 weeks
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Change from baseline in sleep disturbance
大体时间：Baseline, 6 weeks, and 10 weeks
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Sleep disturbance will be assessed using the PROMIS Sleep Disturbance.
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Baseline, 6 weeks, and 10 weeks
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Change from baseline in family communication
大体时间：Baseline, 6 weeks, and 10 weeks
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Family communication will be assessed using the Social Constraint Scale
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Baseline, 6 weeks, and 10 weeks
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Change from baseline in interpersonal closeness
大体时间：Baseline, 6 weeks, and 10 weeks
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Interpersonal closeness will be assessed using the Perceived Interpersonal Closeness Scale.
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Baseline, 6 weeks, and 10 weeks
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Change from baseline in acceptance of illness
大体时间：Baseline, 6 weeks, and 10 weeks
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Acceptance of illness will be assessed using the PEACE Scale.
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Baseline, 6 weeks, and 10 weeks
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Change from baseline in mindfulness
大体时间：Baseline, 6 weeks, and 10 weeks
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Mindfulness will be assessed using the FFMQ-SF Non-reactivity to Internal Experience and Acting with Awareness subscales.
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Baseline, 6 weeks, and 10 weeks
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Distress Thermometer
大体时间：Baseline, 6 weeks, and 10 weeks
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Distress will be assessed using the Distress Thermometer.
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Baseline, 6 weeks, and 10 weeks
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Intervention satisfaction and helpfulness
大体时间：6 weeks
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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).
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6 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Shelley A Johns, PsyD、Indiana University School of Medicine
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年5月9日
初级完成 (实际的)
2017年12月11日
研究完成 (实际的)
2017年12月11日
研究注册日期
首次提交
2017年8月16日
首先提交符合 QC 标准的
2017年8月17日
首次发布 (实际的)
2017年8月22日
研究记录更新
最后更新发布 (实际的)
2020年8月12日
上次提交的符合 QC 标准的更新
2020年8月10日
最后验证
2020年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
生活质量的临床试验
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Swansea University完全的
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Yale-NUS College完全的
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Scripps Translational Science Institute完全的
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Peking Union Medical College Hospital尚未招聘