Using SMART Design to Improve Symptom Management Strategies Among Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 347
- 试验地点
- 14
- 主要终点
- Brief Fatigue Inventory (BFI)
研究概览
简要总结
The purpose of this study is to compare reflexology to meditative practices to reduce symptoms in cancer patients.
详细描述
First, dyads were randomized to receive caregiver-delivered reflexology or meditative practice. Fatigue severity was assesses weekly via phone calls to the cancer patients during weeks 1-4 of the intervention. For patients who did not respond to the intervention during the first 4 weeks, those dyads were referred to as non-responder and re-randomized. A non-responder was determined if the level of reported fatigue remained the same or increased from the first week of the intervention.
The re-randomization placed the non-responders in either a group that received a higher dose (more time) with the first intervention or to the alternate practice (meditative practice to those randomized to reflexology and vice versa) for weeks 5-8. Those who did respond during weeks 1-4 continued the same therapy they began with.
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
- Single (Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •21 year of age or older
- •Solid tumor cancer diagnosis
- •Able to perform basic activities of daily living (ADLs)
- •Undergoing chemotherapy, hormonal therapy, or targeted therapy
- •Able to speak and understand English
- •Have access to a telephone
- •Able to hear normal conversation
- •Reporting a severity of 3 or higher on fatigue using a 0-10 standardized scale at intake.
排除标准
- •Diagnosis of major mental illness on the medical record (verified by the recruiter)
- •Residing in a nursing home
- •Bedridden
- •Currently receiving reflexology or meditative practices
- •Suspected or diagnosed deep vein thrombosis or painful foot neuropathy.
结局指标
主要结局
Brief Fatigue Inventory (BFI)
时间窗: Week 1 -Week 4
Aim 1: Average severity of fatigue over weeks 1-4 Individual Score Range: 0-10 Higher score means worse outcome
The MD Anderson Symptom Inventory (MDASI)- Distress
时间窗: Weeks 1-4
Aim 1: Average severity of distress for weeks 1-4 Individual Score Range: 0-10 Higher score means worse outcome
The MD Anderson Symptom Inventory (MDASI)- Summed Severity
时间窗: Weeks 1-4
Aim 1: Average severity of symptoms from weeks 1-4 Summed range: 0-180 Higher score means worse outcome
The MD Anderson Symptom Inventory (MDASI)- Sadness
时间窗: Weeks 1-4
Aim 1: Average severity of sadness from weeks 1-4 Score range: 0-10 Higher score means worse outcome
次要结局
- Brief Fatigue Inventory (BFI)(Weeks 5-12)
- MD Anderson Symptom Inventory (MDASI)- Summed Severity(Weeks 5-12)
- MD Anderson Symptom Inventory (MDASI)- Distress(Weeks 5-12)
- MD Anderson Symptom Inventory (MDASI)- Sadness(Weeks 5-12)
研究者
Gwen Wyatt
Professor
Michigan State University