Yoga for Painful Chemotherapy-Induced Peripheral Neuropathy: A Pilot, Randomized-Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Frequency of yoga practice by participants
研究概览
简要总结
This research study will examine the feasibility of conducting an eight-week yoga intervention for individuals with chronic painful chemotherapy-induced peripheral neuropathy.
详细描述
This research study will examine the feasibility of conducting an eight-week yoga intervention for individuals with chronic painful chemotherapy-induced peripheral neuropathy. The investigators will also explore participants' perceptions of acceptability and satisfaction with the yoga intervention. Lastly, the investigators will examine changes in chemotherapy-induced peripheral neuropathy severity, physical function, sleep-related impairment, fatigue, anxiety, depression, and pain following the eight-week yoga 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
- 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
- •≥18 years of age,
- •self-report ≥ 4/10 worst chemotherapy-induced peripheral neuropathy pain over the past week,
- •at least three months post neurotoxic chemotherapy completion
- •signed informed consent,
- •willingness to participate in all study activities
- •speak/read English
排除标准
- •prognosis of less than three months,
- •documented peripheral neuropathy due to other causes (e.g., diabetes),
- •planned receipt of neurotoxic chemotherapy during the study period,
- •practice yoga >45 minutes per week over the past six months,
- •diagnosis or documented recent history of significant psychiatric comorbidity (i.e., psychosis, suicidal ideation, or substance abuse)
- •clinician deems that the patient is physically/functionally unable to participate in a yoga program
结局指标
主要结局
Frequency of yoga practice by participants
时间窗: From enrollment to end of treatment at 8 weeks.
Feasibility of participant adherence to the yoga intervention
Number of participants recruited to participate in the study
时间窗: From enrollment to end of treatment at 8 weeks.
Feasibility of participant recruitment to the study
Frequency of outcome assessments completed by participants.
时间窗: From enrollment to end of treatment at 8 weeks.
Feasibility of participant adherence to outcome assessments
次要结局
- Fatigue assessed by Change in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue(At the time of enrollment and at the end of treatment, 8 weeks after enrollment)
- Physical Function(At the time of enrollment and at the end of treatment, at 8 weeks.)
- Anxiety assessed by the "Change in Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety"(At the time of enrollment and at the end of treatment, 8 weeks after enrollment)
- Acceptability and Satisfaction with Participation in Yoga Intervention(At the end of treatment, 8 weeks after enrollment)
- Pain Interference(At the time of enrollment and at the end of treatment, 8 weeks after enrollment)
- Worst Chemotherapy-Induced Peripheral Neuropathy Pain Intensity(At the time of enrollment and at the end of treatment, 8 weeks after enrollment)
- Chemotherapy-Induced Peripheral Neuropathy Severity(From enrollment to end of treatment at 8 weeks.At the time of enrollment and at the end of treatment, 8 weeks after enrollment)
- Sleep-Related Impairment(At the time of enrollment and at the end of treatment, 8 weeks after enrollment)
- Depression assessed by Change in Patient Reported Outcomes Measurement Information System (PROMIS) Depression(At the time of enrollment and at the end of treatment, 8 weeks after enrollment)
研究者
Robert Knoerl, PhD, RN
Principal Investigator
Dana-Farber Cancer Institute