Feasibility Study of Massage Therapy Within a Brain Tumor Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- To assess the feasibility and acceptability of massage therapy provided to primary brain tumor patients. This assessment will integrate data about patient eligibility rates, patient participation rates, patient adherence rates, and adverse events.
研究概览
简要总结
The purpose of this study is
- to assess the feasibility and acceptability of massage therapyto examine the effects of massage therapy
- to explore whether psychological outcomes are associated with changes in patient reported QoL.
详细描述
As a part of this study, we will provide massage therapy to brain tumor patients. Our contribution here is expected to determine whether massage therapy is safe and helps to improve patient QoL. This contribution is significant because it is expected to provide pilot data on effect sizes so that we may design an adequately powered study to develop massage therapy programs and interventions for patients with brain tumors. In addition to benefiting brain tumor patients, the information from this study may be applied to improving the QoL of other cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Patients with histological confirmed, newly diagnosed, post surgical WHO grade III/IV malignant glioma (i.e., glioblastoma, anaplastic astrocytoma) being followed at the Preston Robert Tisch Brain Tumor Center (PRT-BTC) at Duke University Medical Center (DUMC) will be considered potential participants for this study.
- •Additional eligibility criteria will be:
- •> 18 years old
- •Karnofsky Performance Score of > 70 at onset of study
- •estimated life expectancy of > 3 months
- •approval from attending oncologist
- •the ability to speak, read and write English
- •live within a 60 mile radius of the DCL
- •be identified as "stressed" by Perceived Stress Scale (PSS) score, > 12.1 and 13.7 for men and women respectively, and 8) signed informed consent prior to initiation of study-related procedures.
排除标准
- 未提供
结局指标
主要结局
To assess the feasibility and acceptability of massage therapy provided to primary brain tumor patients. This assessment will integrate data about patient eligibility rates, patient participation rates, patient adherence rates, and adverse events.
时间窗: 6 months
次要结局
- To examine the effects of massage therapy on psychological outcomes related to stress, distress, anxiety, and depression in this population and to explore whether psychological outcomes are associated with changes in patient reported QoL.(12 months)