Self-Guided Online Cognitive Behavioral Strategies for Chemotherapy-Induced Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 10
- 主要终点
- Change in 0 - 10 Numerical Rating Scale of Worst Pain Intensity Scores at 8 Weeks
研究概览
简要总结
The purpose of this pilot randomized wait-list controlled trial is to test the efficacy of an online cognitive behavioral pain management website called Proactive Self-Management Program for Effects of Cancer Treatment (PROPSECT) to reduce worst pain intensity for individuals with chronic painful chemotherapy-induced peripheral neuropathy (CIPN) and to explore the mediating effect of PROSPECT-induced changes in anxiety, fatigue, depression, and sleep disturbance on worst pain intensity. Another aim of this study is to determine whether PROSPECT will decrease CIPN symptom severity (e.g. non-painful numbness and tingling), average pain severity, and physical impairment. Lastly, since this intervention has never been tested in individuals with painful CIPN, the investigators will assess patients' perceptions of acceptability and satisfaction with 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
- Single (Investigator)
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •over 25 years of age
- •self-report 4/10 worst CIPN pain that has persisted three months or longer after the cessation of their neurotoxic chemotherapy regimen
- •have at least grade one sensory CIPN as defined by their oncology provider using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
- •have a stable analgesic medication regimen as evidenced by a less than 10% increase or decrease in their analgesic medication dosage in the two weeks leading up to their enrollment in the study
- •have internet access
- •self-report the ability to use a computer
- •signed informed consent
- •willingness to participate in all study activities.
排除标准
- •prognosis of less than three months
- •documented peripheral neuropathy due to other causes (diabetes, alcohol abuse, Central Nervous System malignancy, vitamin B deficiency, hereditary, nerve compression injury)
- •neurotoxic chemotherapy treatment regimens are planned to occur while enrolled in the study
- •have participated in cognitive behavioral pain management in the past or plan to enroll in cognitive behavioral pain management during the course of the intervention.
研究组 & 干预措施
Online Self Management
Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.
干预措施: Proactive Self Management Program for Effects of Cancer Treatment (Device)
Control
Treatment as usual
结局指标
主要结局
Change in 0 - 10 Numerical Rating Scale of Worst Pain Intensity Scores at 8 Weeks
时间窗: Baseline to 8 weeks
Pain is measured on the numerical rating scale of 0 - 10 where 0 is no pain and 10 is worst imaginable pain.
次要结局
- Change in PROMIS Short Form Emotional Distress - Depression 4a Scores at 8 Weeks(Baseline to 8 weeks)
- PROMIS Short Form Anxiety 4a(Baseline to 8 weeks)
- Change in PROMIS Short Form Fatigue 4a Scores at 8 Weeks(Baseline to 8 weeks)
- Change in PROMIS Short Form Sleep-Related Impairment 8a Scores at 8 Weeks(Baseline to 8 weeks)
- Patient Global Impression of Change(8 week)
- Change in 0 - 10 Average Pain Intensity Numerical Rating Scale Scores at 8 Weeks(Baseline to 8 weeks)
- Adapted Acceptability E-Scale(8 week)
- Change in European Organization of Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy Scale Scores at 8 Weeks(Baseline to 8 weeks)
- Change in PROMIS Pain Interference 4a Scores at 8 Weeks(Baseline to 8 weeks)
研究者
Robert Knoerl
Dr.
University of Michigan