On the BRINK: PhotoBiomodulation (PBM) for Mucositis in Patients Undergoing Allogeneic Hematopoietic Stem Cell TRansplant (HSCT) - Implementing the Evidence &Amp; Discovering New Knowledge
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Mucositis according to the World Health Organization (WHO) Scale
研究概览
简要总结
This study evaluates mucositis and other oral symptoms in patients undergoing photobiomodulation in patients undergoing hematopoietic stem cell transplantation.
详细描述
PRIMARY OBJECTIVE:
I. Examine mucositis severity, oral pain, taste changes, and xerostomia in patients undergoing PBM, a new standard of care for oral mucositis.
OUTLINE: This is an observational study. Participants are assigned to 1 of 2 groups.
GROUP I: Patients have their medical records reviewed on study.
GROUP II: Nurses complete surveys on study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •PATIENTS:
- •Age: ≥ 18 years
- •Undergoing allogeneic HSCT - cases where PBM was used and cases where PBM was not used
- •Nurses who administer PBM
排除标准
- 未提供
研究组 & 干预措施
Group I (Patients)
Patients have their medical records reviewed on study.
干预措施: Non-Interventional Study (Other)
Group II (Nurses)
Nurses complete surveys on study.
干预措施: Non-Interventional Study (Other)
结局指标
主要结局
Mucositis according to the World Health Organization (WHO) Scale
时间窗: Up to 22 days or until discharge, whichever came first
WHO scale is a combined patient-reported and clinician assessed rating scale that ranges from 0 ( no oral mucositis) to IV (Life threatening mucosistis).
Average oral pain
时间窗: Up to 22 days or until discharge, whichever came first
Patient is asked to rate their pain on a 0 - 10 scale with 0 being no pain and 10 being the worst possible pain.
Taste
时间窗: Up to 22 days or until discharge, whichever came first
Taste according to the Chemotherapy Induced Taste Alteration Scale (CiTAS) which is an 18-item scale that measures four dimensions of taste: decline in basic taste, discomfort, phantogeusia and parageusia, and general taste alterations. Items are stated on a Likert scale 1 - 5 (where 1 = no difficulty or absence of the disturbance and 5 = maximum difficulty or disturbance.
Xerostomia
时间窗: Up to 22 days or until discharge, whichever came first
Xerostomia severity (0-10 scale)
次要结局
未报告次要终点