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
- 1
- 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
研究组 & 干预措施
Yoga Program
Eight-weeks, therapist and self-guided yoga
干预措施: Yoga (Behavioral)
Treatment as usual
Control group participants will continue to receive usual care and symptom management strategies from clinicians during the study.
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