POEM (Practice of Embracing Each Moment) Study (Delivery Science)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Change in Hospital Anxiety and Depression Scale
研究概览
简要总结
The objective of the proposed pilot pragmatic cluster randomized trial targeting cancer patients undergoing palliative and supportive therapy and their informal caregivers is to pilot test implementation of mHealth two mindfulness interventions as part of standard palliative care support within Kaiser Permanente Northern California.
详细描述
A cancer diagnosis is associated with high levels of distress in both patients and their family caregivers. Although studies have demonstrated that mindfulness-based interventions are effective in reducing distress and anxiety of cancer patients, logistical limitations of currently available mindfulness-based stress reduction training options restrict their potential to benefit patients with advanced cancer and their caregivers. Previous pilot mindfulness studies targeting cancer patients and caregivers have demonstrated preliminary feasibility and acceptability of mHealth mindfulness interventions and preliminary efficacy in reducing depression, anxiety and improving quality of life. The objective of the proposed pilot pragmatic cluster randomized trial targeting cancer patients undergoing palliative and supportive therapy and their informal caregivers is to pilot test implementation of two mHealth mindfulness interventions as part of standard palliative care support within KPNC. Using data collected through the mindfulness programs, patient/caregiver surveys, clinician surveys, and EHR data, the study aims are: 1) to assess acceptability and feasibility of incorporating an mHealth mindfulness intervention as part of palliative care and to obtain preliminary efficacy of the intervention on patient-reported outcomes, clinical outcomes, and health care utilization; and 2) to gather qualitative feedback regarding the intervention from the clinicians, patients and caregivers. Participating oncology clinics will be randomized into either intervention or usual care arms. Intervention participants may choose from a 6-week webinar-based mindfulness program or a 6-week self-paced mobile app-based mindfulness program. Controls will receive usual care. Rates of participation, completion and adherence among intervention participants and participant-reported outcomes on distress and quality of life among both arms at baseline, post-intervention and 12 weeks will be collected. The hypothesis is that participants in the intervention arm will experience reductions in depression/anxiety and improvement in immune function and quality of life. Clinician surveys and interviews with intervention participants will also be conducted at the end of the intervention to obtain feedback regarding the intervention.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Smartphone or tablet ownership OR has a computer with internet access
- •Ability to read and understand English
- •Patients: current Kaiser Permanente member with diagnosis of cancer and receiving palliative or supportive therapy at one of the participating oncology clinics
- •Caregivers: primary unpaid support person of the patient who takes care of the patient at least two hours a week.
排除标准
- •Severe hearing impairment
- •Severe mental illness
研究组 & 干预措施
Control
Participants from medical centers assigned to the control arm will receive usual care.
Intervention
Participants from medical centers assigned to the intervention arm will receive access to their choice of a mindfulness app or a webinar-based mindfulness course for 6 weeks.
干预措施: Mindfulness meditation (Behavioral)
结局指标
主要结局
Change in Hospital Anxiety and Depression Scale
时间窗: Baseline to 12 weeks
The 14-item Hospital Anxiety and Depression Scale (HADS) assesses anxiety and depression. Each subscale (depression and anxiety) is scored from 0 to 21 by summing individual item scores, with higher scores indicating greater anxiety and depression; 0-7 is generally considered within normal range.
Change in Hospital Anxiety and Depression Scale
时间窗: Baseline to 6 weeks
The 14-item Hospital Anxiety and Depression Scale (HADS) assesses anxiety and depression. Each subscale (depression and anxiety) is scored from 0 to 21 by summing individual item scores, with higher scores indicating greater anxiety and depression; 0-7 is generally considered within normal range.
次要结局
- Change in PROMIS pain interference scale (caregivers only)(Baseline to 12 weeks)
- Change in PROMIS sleep disturbance scale (caregivers only)(Baseline to 12 weeks)
- Change in Functional Assessment of Chronic Illness Therapy-Palliative care (patients only)(Baseline to 12 weeks)
- Change in Brief COPE coping strategy questionnaire (patients only)(Baseline to 12 weeks)
- Change in Distress Thermometer(Baseline to 12 weeks)
- Change in Five Facet Mindfulness Questionnaire(Baseline to 12 weeks)
- Change in Caregiver Quality of Life-Cancer scale (caregivers only)(Baseline to 12 weeks)
- Change in Post-Traumatic Growth Inventory(Baseline to 12 weeks)
- Change in Brief Fatigue Inventory (caregivers only)(Baseline to 12 weeks)
- Change in Functional Assessment of Chronic Illness Therapy-Palliative care (patients only)(Baseline to 6 weeks)
- Change in Brief COPE coping strategy questionnaire (patients only)(Baseline to 6 weeks)
- Change in Post-Traumatic Growth Inventory(Baseline to 6 weeks)
- Change in Five Facet Mindfulness Questionnaire(Baseline to 6 weeks)
- Change in Caregiver Quality of Life-Cancer scale (caregivers only)(Baseline to 6 weeks)
- Change in PROMIS pain interference scale (caregivers only)(Baseline to 6 weeks)
- Change in PROMIS sleep disturbance scale (caregivers only)(Baseline to 6 weeks)
- Change in Brief Fatigue Inventory (caregivers only)(Baseline to 6 weeks)
- Change in Distress Thermometer(Baseline to 6 weeks)