A Pilot Study of Mindfulness-Based Stress Reduction (MBSR) in Patients With Cancer Experiencing Stress Who Live in Underserved and Rural Regions of Minnesota
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Completion Rate
研究概览
简要总结
This clinical trial evaluates whether a virtual stress reduction program that uses mindfulness-based stress reduction (MBSR) techniques works to improve mental health outcomes in cancer patients living in underserved/rural regions of Minnesota. 80% of Minnesota counties are considered mental health care shortage areas. This shortage disproportionately impacts Minnesotans living in underserved and rural regions as they have to travel further for mental health care services. Interventions that provide patients with mental health resources from the comfort of their own home help to reduce barriers that limit access to mental health care. MBSR courses can help patients control their responses to stressful events, reduce the impact of chronic stress, develop more effective ways to cope with medical/psychological conditions, and increase overall sense of well-being. MBSR courses may serve as a way to bridge the gap between mental health care and patients with cancer living in underserved/rural regions of Minnesota.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a history of cancer, or currently have cancer
- •Patients reporting > 4/10 emotional distress on a 0-10 scale within the past six months
- •Patients with a Rural-Urban Commuting Area (RUCA) code of 4 or greater
- •Have a computer or smartphone
- •Willing to complete questionnaires
排除标准
- •Non-English-speaking patients
- •Life expectancy < 12 months
- •Active psychiatric disease
研究组 & 干预措施
Supportive care (MBSR)
Patients participate in MBSR sessions weekly for 8 weeks.
干预措施: Electronic Health Record Review (Other)
Supportive care (MBSR)
Patients participate in MBSR sessions weekly for 8 weeks.
干预措施: Mindfulness Relaxation (Behavioral)
Supportive care (MBSR)
Patients participate in MBSR sessions weekly for 8 weeks.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Completion Rate
时间窗: Up to 10 weeks
Assessed by the number of participants who complete the virtual stress reduction program (MBSR) program
Change in Stress
时间窗: Baseline, at completion of 8-week course, 3 months, 6 months
Assessed using the 10-item Perceived Stress Scale (PSS), which measures global perceived stress experienced by the participant over the preceding 30 days. The PSS consists of 10 questions assessing how often the participant felt or thought a certain way during the past month. Possible answers include: 0 - never; 1 - almost never; 2 - sometimes; 3 - fairly often, and 4 - very often. Possible scores range from 0 to 40, with lower scores indicating a better outcome (less stress).
Change in Anxiety
时间窗: Baseline, at completion of 8-week course, 3 months, 6 months
Assessed using the General Anxiety Disorder 7-item (GAD-7) scale. The GAD-7 consists of 7 questions answered on a scale of 0-3 where 0=not at all, 1=several days, 2=more than half the days, and 3=nearly every days. The total score ranges from 0 to 21 where 0 indicates no anxiety, 1-4 indicates minimal anxiety, 5-9 indicates mild anxiety, 10-14 indicates moderate anxiety, and 15-21 indicates severe anxiety.
Change in Mindfulness
时间窗: Baseline, at completion of 8-week course, 3 months, 6 months
Assessed using the Mindful Attention Awareness Scale (MAAS), a 15-item scale designed to assess a core characteristic of dispositional mindfulness (open or receptive awareness of and attention to what is taking place in the present). The MAAS consists of 15 statements about everyday experience, with each item answered on a scale ranging from 1 (almost always) to 6 (almost never) to indicate how frequently or infrequently participants have each experience. The MAAS is scored by computing a mean (average) of all 15 items. Higher scores reflect higher levels of dispositional mindfulness.
Barriers to completion of the course
时间窗: 10 weeks post course enrollment
Assessed using a study-specific questionnaire. Responses will be evaluated and reported descriptively.
次要结局
未报告次要终点