Meaning-Centered Pain Coping Skills Training: A Randomized Pilot Trial for Patients With Advanced Cancer and Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Feasibility as measured by attrition
研究概览
简要总结
This study is a randomized clinical trial of a psychosocial pain management intervention called, Meaning-Centered Pain Coping Skills Training (MCPC). Patients with advanced solid tumor cancer and at least moderate pain will be randomized to MCPC or a standard care control condition. Patient-reported outcomes will be assessed at baseline and 5- and 10-week follow-ups. The first aim of this study is to assess the feasibility of conducting a randomized clinical trial to test MCPC. The second aim is to characterize MCPC's effects on patient-reported outcomes of pain severity, pain interference, meaning in life, self-efficacy for pain management, and psychological distress. The third aim is to describe participants' experiences of MCPC using semi-structured qualitative interviews. The risk and safety issues in this trial are low and limited to those common to a psychosocial intervention (e.g., loss of confidentiality).
详细描述
Many patients with advanced cancer describe pain as their most feared and distressing symptom. In this population, higher pain levels often predict worse physical, emotional, and existential/spiritual well-being. Psychosocial interventions show promise for improving cancer-related pain; however, no interventions address existential concerns (e.g., a loss of meaning in life) that are common among those facing pain from advanced illness. To address this need, an intervention called Meaning-Centered Pain Coping Skills Training (MCPC) was developed. MCPC seeks to teach patients cognitive and behavioral skills for managing pain (e.g., guided imagery) in order to help them engage with what gives their life a sense of meaning, purpose, and significance.
This pilot study is being conducted to prepare for a large-scale clinical trial that will test the efficacy of MCPC for improving patients' pain and pain-related outcomes.
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
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
- •Stage IV solid tumor cancer diagnosis; or stage III pancreatic or lung cancer diagnosis
- •At least moderate pain (worst pain in past week >/= 4 out of 10) at screening
- •Eastern Cooperative Oncology Group (ECOG) performance status </= 2 at screening
- •Ability to speak and read English
排除标准
- •Brain tumor diagnosis
- •Significant cognitive impairment
- •Untreated serious mental illness that would interfere with engagement in the interventions (e.g., schizophrenia)
- •Previous engagement in Pain Coping Skills Training or Meaning-Centered Psychotherapy
- •Enrollment in hospice
结局指标
主要结局
Feasibility as measured by attrition
时间窗: 5-week follow-up (immediately post-intervention)
Treatment feasibility will be evidenced by no more than 25% attrition by the 5-week follow-up.
Feasibility as measured by study accrual
时间窗: Baseline
Treatment feasibility will be evidenced by meeting study accrual (N = 60).
Feasibility as measured by adherence and assessment completion
时间窗: 5-week follow-up (immediately post-intervention)
Treatment feasibility will be evidenced by at least 75% of participants completing all four intervention sessions as well as the 5-week follow-up assessment.
次要结局
- Change in meaning in life(Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up)
- Change in anxiety(Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up)
- Change in hopelessness(Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up)
- Change in pain interference(Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up)
- Change in self-efficacy for pain management(Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up)
- Change in depressive symptoms(Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up)
- Change in pain severity(Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up)