Meaning-Centered Pain Coping Skills Training: A Randomized Controlled Trial of a Psychosocial Intervention for Advanced Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 211
- 试验地点
- 1
- 主要终点
- Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference-Short Form
研究概览
简要总结
This study is a randomized controlled trial of a psychosocial pain management intervention called, Meaning-Centered Pain Coping Skills Training (MCPC). Patients with advanced solid tumor cancer and pain interference will be randomized to MCPC or a standard care control condition. Patient-reported outcomes will be assessed at baseline and 8- and 12-week follow-ups. 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 a debilitating symptom that greatly interferes with activities they care about. Psychosocial interventions show promise for improving cancer-related pain; however, there is a lack of interventions that address existential and spiritual concerns (e.g., a loss of meaning, purpose, and peace) that are common among those facing high levels of pain interference from advanced cancer.
To address this need, an intervention called Meaning-Centered Pain Coping Skills Training (MCPC) was developed. In this trial, the investigators will randomize patients to MCPC or enhanced usual care control (target N = 210). Patient-reported outcomes will be assessed at baseline and 8- and 12-weeks after baseline. As in the investigators' extensive pilot work, MCPC's four 45-to-60 minute individual weekly sessions will be delivered by trained study therapists via an accessible videoconference format. Intervention sessions focus on training participants in evidence-based cognitive-behavioral skills, such as guided imagery and activity pacing. Emphasis is placed on using skills to reduce the degree to which pain interferes with participants' sense of meaning, purpose, and peace.
The first aim of this trial is to determine the efficacy of MCPC for reducing the primary outcome of pain interference at 8-weeks. The second aim is to determine the efficacy of MCPC for improving secondary outcomes at 8-weeks. The third aim is to test the maintenance of MCPC's effects on primary and secondary outcomes at 12-weeks. The fourth aim is to estimate the cost-effectiveness of implementing MCPC.
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
- •Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower
- •At least one clinical pain severity rating > 0 out of 10 in past month
- •At least moderate pain interference (8-item Patient-Reported Outcomes Measurement Information System [PROMIS] Pain Interference T-score >/= 55) in the past week at telephone screening
- •Ability to speak and read in English
- •Age >/= 18 years.
排除标准
- •Significant cognitive impairment as indicated in medical chart or during telephone screening
- •Serious untreated mental illness
- •Primary brain cancer diagnosis
- •Previous engagement in Pain Coping Skills Training or Meaning-Centered Psychotherapy
- •Enrollment in hospice at screening
研究组 & 干预措施
Meaning-Centered Pain Coping Skills Training
Four, 45-60 minute, videoconference-delivered sessions focus on training participants in cognitive and behavioral skills (e.g., guided imagery, activity pacing) for managing pain.
干预措施: Meaning-Centered Pain Coping Skills Training (Behavioral)
Standard Care
Information and referrals for free services available through the Duke Cancer Patient Support Program.
结局指标
主要结局
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference-Short Form
时间窗: 8-week follow-up
This 8-item measure assesses the degree to which, over the past 7 days, pain has interfered with daily activities, work around the home, engagement in social activities, household chores, fun activities, enjoyment of social activities, enjoyment of life, and family life. Response options range from 1 (not at all) to 5 (very much). Higher scores indicate worse pain interference.
次要结局
- Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety-Short Form(8-week follow-up and 12-week follow-up)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference-Short Form(12-week follow-up)
- Brief Pain Inventory-Short Form (BPI-SF) Pain Severity Subscale(8-week follow-up and 12-week follow-up)
- Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp)(8-week follow-up and 12-week follow-up)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Depression-Short Form(8-week follow-up and 12-week follow-up)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Meaning and Purpose Scale(8-week follow-up and 12-week follow-up)
- Chronic Pain Self-Efficacy Scale (CPS)(8-week follow-up and 12-week follow-up)
- Medical Outcomes Study Social Support Survey (MOS-SS)(8-week follow-up and 12-week follow-up)
- 5-item 5-level EuroQol Group (EQ-5D-5L)(8-week follow-up and 12-week follow-up)