Caregiver-Guided Pain Management Training in Palliative Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 452
- 试验地点
- 2
- 主要终点
- Change in caregiver self-efficacy for helping the patient manage pain
研究概览
简要总结
The purpose of this study is to develop more effective ways to help patients and their caregivers cope with cancer pain. The investigators are looking at the usefulness of a Caregiver-Guided Pain Management Training Intervention versus Pain Education.
详细描述
The primary aim of this study is to test the efficacy for the Caregiver-Guided Pain Management Training intervention to improve the caregiver's self-efficacy for helping the patient manage pain. Secondary aims include testing the effectiveness of the CG-PMT intervention to improve patient pain severity, patient self-efficacy for pain management and patient psychological distress, as well as short-term caregiver adjustment and caregiver adjustment following the patient's death.
In this multi-site study, 236 dyads (patients with cancer pain and their family caregivers) will be randomized to either a Caregiver-Guided Pain Management Training protocol or to an Enhanced Treatment-as-Usual control condition. Dyads in the Caregiver-Guided Pain Management condition will receive three one-hour sessions conducted via videoconference. Dyads in the Enhanced Treatment-as-Usual condition will receive educational material about cancer pain and its management but will not receive any study-related treatment sessions. Assessments will be conducted with patients and caregivers before and after treatment, and with caregivers 3 months and 6 months following the patient's death. The primary hypothesis to be tested is that caregivers who receive the intervention will report significantly higher levels of self-efficacy for helping the patient manage pain than caregivers in the control condition. Secondary aims will focus on (a) improvements in short-term caregiver adjustment as well as caregiver adjustment following the patient's death, and (b) patient pain severity, self-efficacy for pain management, and psychological distress.
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
- •clinical diagnosis Stage 4 solid or hematologic malignancy and nonresectable Stage 3 gastrointestinal (GI) cancer
- •life expectancy of < 1 month
- •worst pain in the past 2 weeks greater than or equal to 4 on the 0-10 pain scale,
- •have an identified caregiver who is also willing to participate,
- •at least 18 years old, 6) fluent in English.
- •Caregiver Inclusion Criteria:
- •at least 18 years old
- •fluent in English
排除标准
- •Palliative Performance Scale rating <40,
- •current external radiation therapy for reduction of pain
- •unable to provide informed consent or complete study procedures as determined by clinical or study staff.
- •Caregiver Exclusion Criteria:
- •unable to provide informed consent or complete study procedures as determined by clinical or study staff.
结局指标
主要结局
Change in caregiver self-efficacy for helping the patient manage pain
时间窗: baseline, post-intervention (3 weeks)
Caregiver Self-Efficacy Scale
次要结局
- Change in patient self-efficacy(baseline, post-intervention (3 weeks))
- Change in caregiver health behaviors(following death of patient (3 mos & 6 mos))
- Change in caregiver global health rating(following death of patient (3 mos & 6 mos))
- Change in caregiver strain(baseline, following intervention (3 weeks))
- Change in caregiver satisfaction(baseline, following intervention (3 weeks))
- Change in caregiver psychological distress(following death of patient (3 mos & 6 mos))
- Change in patient pain(baseline, post-intervention (3 weeks))
- Change in patient psychological distress(baseline, post-intervention (3 weeks))