Survivor Warming to Alter Mood (S-WARM)
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in depression
研究概览
简要总结
This early phase I trial evaluates the effect of thermal therapy on depression with or without sleep disturbance in cancer survivors. Thermal therapy may help improve quality of life, physical capacity, fatigue, and enhance positive mood and sleep quality. The purpose of this study is to evaluate the potential of thermal therapy to improve patient's quality of life by reducing symptoms of depression, sleep disruption, fatigue and anxiety in cancer survivors.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate the potential of thermal therapy to improve quality of life by reducing symptoms of depression in cancer survivors.
SECONDARY OBJECTIVE:
I. To evaluate the potential of thermal therapy to improve quality of life by reducing symptoms of sleep disruption in cancer survivors.
EXPLORATORY OBJECTIVE:
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 who have had therapy for malignancy
- •Age >= 18 years
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
- •Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
- •Patient denies current pregnancy
- •Patients who screen positive on the depression/anxiety domain will be given the Hamilton Depression Rating Scale. Those with a score of 16 or more on this scale will be eligible for intervention
排除标准
- •History of prior myocardial infarction. These patients may be allowed with clearance from a cardiologist
- •History of any condition deemed by the principal investigator to be a contraindication to S-WARM therapy (e.g., skin reaction, dysregulation of thermoregulation, etc.)
- •All patients with transdermal patches (e.g.; fentanyl, Lidoderm, scopolamine, etc.)
- •Unwilling or unable to follow protocol requirements
- •Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive S-WARM
- •Received an investigational agent within 30 days prior to enrollment
- •Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Patients on dialysis
结局指标
主要结局
Change in depression
时间窗: Baseline to 1 or 2 weeks after completion of therapy
Measured by the Hamilton Depression Rating Scale.
次要结局
- Change in Pittsburgh Sleep Quality Index scores(Baseline, up to 4 months)
- Durability of and variability in the response over time(Up to 4 months after completion of therapy)