Feasibility and Preliminary Efficacy of Hatha Yoga in Head and Neck Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Number of patients who complete a modified Yoga program for HNC survivors
研究概览
简要总结
Treatment for head and neck cancer can result in marked musculo-skeletal impairment (MSI). This study will examine the effects of Hatha Yoga as a therapeutic modality to address MSI.
详细描述
The use of aggressive treatment for head and neck cancer (HNC) particularly combined modality treatment regimens has resulted in an increase in survival. Unfortunately, this improvement has come with a marked increase in acute and late-effects. Acute HNC treatment-related toxicities have been clearly and extensively documented; however, data pertaining to adverse late-effects, those most likely to impact the survivor's long term symptom burden, functionality, and overall quality of life (QOL), are limited. This pilot study will be conducted to examine the feasibility of tailored Hatha Yoga as a therapeutic modality to address MSI in patients who have survived HNC.
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
- •>3 months post-treatment of HNC
- •no active cancer
- •ability to understand English in order to complete questionnaires
- •willing to participate in the guided and home Yoga practice
- •willing to drive to the study site
- •willing and able to provide informed consent
- •completed medically indicated physical therapy
- •medical clearance by study medical oncologist
排除标准
- •a prior cancer diagnosis within the past three years (except basal cell, surgically treated squamous cell skin cancer, early prostate cancer under observation)
- •have received radiation therapy or chemotherapy for any condition other than primary HNC
- •medical conditions that would prohibit the safe implementation of a Yoga practice (e.g., vertigo, dementia)
- •active Yoga practice within the past 6 months
结局指标
主要结局
Number of patients who complete a modified Yoga program for HNC survivors
时间窗: at 8 weeks
Number of patients that complete an 8-week course of guided yoga sessions and that complete a Participant Practice Log to document their non-guided home yoga sessions
次要结局
- Change in cervical ROM(at 8 weeks)
- Change in head and neck-related treatment systems(at 8 weeks)
- Change in Brief Pain Inventory(at 8 weeks)
- Change in Anxiety and Depression Scale(8 weeks)
- Change in Body Image Quality of Life Inventory(at 8 weeks)
- Change in range of motion (ROM) jaw maximal inter-incisoral opening(at 8 weeks)
研究者
Sheila Ridner
Martha Rivers Ingram Professor of Nursing
Vanderbilt-Ingram Cancer Center