Comparing Two Ways to Manage Lymphedema in Head and Neck Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 240
- 试验地点
- 12
- 主要终点
- Changes in severity of lymphedema
研究概览
简要总结
This randomized clinical trial aims to compare clinic-based CDT and home-based (a hybrid model) CDT on changes in the severity of lymphedema, symptom burden, functional status, and healthcare utilization in HNC survivors with lymphedema.
详细描述
Primary aim: To compare the effects of clinic-based and home-based (a hybrid model) CDT on changes in the severity of lymphedema.
Secondary aim: To compare the effects of clinic-based and home-based (a hybrid model) CDT on symptom burden and functional status.
Exploratory aim: To compare the healthcare utilization between patients receiving clinic-based versus home-based (a hybrid model) CDT
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •>18 years of age
- •<=24 months post-HNC treatment
- •Diagnosis of head and neck lymphedema and referral by their oncology providers
- •Able to perform self-manual lymphatic drainage
- •Having an electronic device (a computer, tablet, iPad, laptop, or smartphone) and internet access at home
排除标准
- •Active infection in soft tissues in the head and neck region
- •History of moderate or severe carotid artery occlusion
- •Significantly severe lymphedema (e.g., severe periorbital swelling)
- •Conditions impacting the safe delivery of lymphedema therapy
研究组 & 干预措施
Clinic-Based Lymphedema Therapy
干预措施: Clinic-based CDT (Other)
Home-Based (a hybrid model) Lymphedema Therapy
干预措施: Home-based (a hybrid model) CDT (Other)
结局指标
主要结局
Changes in severity of lymphedema
时间窗: Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention
Compare the effects of clinic-based and home-based CDT on changes in the severity of lymphedema. This outcome measure will be assessed via Head and Neck - External Lymphedema and Fibrosis Assessment Criteria (HN-LEF Assessment Criteria).
次要结局
- Changes in degrees of jaw range of motion(Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention)
- Changes in degrees of cervical range of motion(Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention)
- Changes in severity of symptom burden(Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention)
研究者
Jie Deng
Associate Professor
University of Pennsylvania