A Pilot Study to Define PROs for Establishing a Pathway for Post Radiation or Concurrent Chemo Radiation (RT/CRT) Patient Care for Oropharyngeal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Scores of symptoms on the MD Anderson Symptom Inventory - Head and Neck (MDASI-HN) relevant to toxicities
研究概览
简要总结
This study examines patient reported outcomes post radiation therapy or chemoradiotherapy patient care in patients with oropharyngeal cancer. This study may help researchers learn about the symptoms that patients with oropharyngeal cancer have after completing radiation therapy.
详细描述
PRIMARY OBJECTIVE:
I. To provide evidence of clinically relevant symptoms for integrating into a user-friendly, automated pathway for real-time tracking and management of symptoms during post radiation therapy (RT)/chemoradiation (CRT) for oropharyngeal cancer (OPC).
OUTLINE:
Patients complete questionnaire over 10-20 minutes at baseline, 2 times every week during weeks 1-8 of radiation therapy, and at the end of the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 were seen for new patient evaluation at clinics and HNC centers at MD Anderson Cancer Center
- •Adult patients with OPC (> 18 years old) who have been enrolled under PA14-0947
排除标准
- 未提供
研究组 & 干预措施
Observational (questionnaire)
Patients complete questionnaire over 10-20 minutes at baseline, 2 times every week during weeks 1-8 of radiation therapy, and at the end of the study.
干预措施: Electronic Health Record Review (Other)
Observational (questionnaire)
Patients complete questionnaire over 10-20 minutes at baseline, 2 times every week during weeks 1-8 of radiation therapy, and at the end of the study.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Scores of symptoms on the MD Anderson Symptom Inventory - Head and Neck (MDASI-HN) relevant to toxicities
时间窗: From the end of radiation therapy (RT)/chemoradiotherapy (CRT) treatment to 2 months post-treatment
All symptom PRO items on MDASI-HN (MD Anderson Symptom Inventory - Head and Neck (MDASI) would be rated by patients on 0 -10 of severity scale, with 0 being no symptom, and 10 being symptom as bas as imagine.
次要结局
未报告次要终点