Development and Application of a Nurse-Led Preemptive Symptom Management Protocol for Head and Neck Cancer Patients Undergoing Radiation Therapy
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 170
- 主要终点
- Radiotherapy interruption rate
研究概览
简要总结
The aim of this study is to investigate whether a nurse-led preemptive symptom management protocol can reduce the radiation therapy interruption rate in patients with head and neck cancer compared to conventional care models.
详细描述
The aim of this study is to investigate whether a nurse-led preemptive symptom management protocol can reduce the radiation therapy interruption rate in patients with head and neck cancer compared to conventional care models. The secondary objective is to evaluate whether the nurse-led preemptive symptom management protocol improves symptoms, quality of life, and psychological well-being in head and neck cancer patients undergoing radiation therapy compared to conventional care models.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients had pathologically confirmed malignant head and neck tumors without distant metastasis.
- •Patient age ≥18 years; Patients were scheduled to undergo either postoperative adjuvant radiotherapy or radical radiotherapy, with or without concurrent chemotherapy.
- •Baseline ECOG (Eastern Cooperative Oncology Group) score 0-2;
- •Good cognitive and reading skills, able to complete the questionnaire survey.
排除标准
- •Presence of other malignant tumors aside from head and neck malignancies;
- •A history of prior head and neck radiotherapy;
- •Mental illness or cognitive impairments;
- •Uncontrolled systemic diseases that could significantly affect their QoL.
研究组 & 干预措施
Intervention group
Patients in the intervention group will receive a structured nurse-led preemptive symptom management protocol. This protocol, centered around trained oncology specialist nurses, involves systematic visits conducted before, during, and after radiotherapy. The intervention encompasses four key components: symptom monitoring and management guided by a standardized manual, emotional and psychological support integrating family involvement and traditional cultural values, family-unit-based education and skills training, and care coordination ensuring multidisciplinary communication. The core of the intervention is the nurse's sustained engagement to proactively prevent and manage symptoms while reinforcing the family's role within the support system.
干预措施: Nurse-led preemptive symptom management (Behavioral)
Control group
Patients in the control group will receive conventional care, which encompasses standardized nursing procedures, routine health education (including information related to radiotherapy) and so on.
干预措施: Concentional care (Behavioral)
结局指标
主要结局
Radiotherapy interruption rate
时间窗: The time period is the period from the start of radiotherapy to the completion of radiotherapy.The evaluation period is approximately 6 weeks and 6.5 weeks.
The number of patients who missed five or more consecutive radiations and the reasons for this are recorded during radiotherapy.
次要结局
- Rehospitalization rate(The time frame spans from the commencement of radiotherapy to three months post-radiotherapy, with an approximate total evaluation period of five months.)
研究者
Xingchen Peng
PhD, Professor
West China Hospital