Nurse-Led Individualized Follow-Up Intervention Versus Regular Physician-Led Visits in Nasopharyngeal Carcinoma: A Phase III Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 250
- 主要终点
- Quality of life score (EORTC QLQ C30)
研究概览
简要总结
The incidence of nasopharyngeal carcinomas (NPCs) is highly unbalanced around the globe, primarily concentrated in East and Southeast Asia.There is no well-conducted, larger randomized controlled trials (RCT) outlining a gold standard for follow-up programs ensuring early detection of recurrence, good management of symptoms and cost-effectiveness. The primary aim of this randomised, controlled trial is to test whether a nurse-led individually tailored symptom management program will significantly reduce reported symptoms among NPC patients following primary treatment compared to physician-led scheduled follow-up. Additionally, the investigators will assess patient activation (self-management), anxiety, depression, fear of recurrence, work abilities, recurrence times, changes in health behavior, and health care utilization and costs for the two arms of the study.
A nurse-led education program focused on symptom management is provided to patients, along with an electronic platform to report symptoms to nurses and support in symptom management.
详细描述
It is planned to recruit 250 primary NPC patients from Fujian Cancer Hospital's Oncology Departments during an 18-month period, after completing the chemoradiotherapy for NPC. You will participate in a five-year study in which you are randomly assigned to either the nurse-led intervention or the physician-led intervention. Regardless of group assignment, you will follow the national nasopharyngeal carcinoma screening program.
Both the control and intervention arms will use questionnaires, clinical databases, and national registers to collect data for 5 years after inclusion both in the control and intervention groups. The primary and secondary outcomes are measured using questionnaires in both groups, whereas Patient Reported Outcomes (PRO) are collected only in the intervention group. Relapsed patients will not be asked to complete the remaining outcome questionnaires or PROs since they quit the follow-up program to pursue recurrent treatment. If PROs reveal a need, or if the patient requires consultation, the nurse or project physician will be consulted.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide informed consent;
- •Have completed radiotherapy treatment for loco-regional nasopharyngeal carcinoma without clinical sign of distance metastatis;
- •Aged 18 years and above;
- •Expected survival ≥6 months;
- •Read, understand Chinese characters and speak Mandarin.
排除标准
- •Previous history of other malignancies, mental illness or cognitive impairment (MMSE score < 27 points);
- •Unstable medical or psychiatric conditions
- •Inability to communicate effectively in mandarin
- •Pregnant women or lactating women.
结局指标
主要结局
Quality of life score (EORTC QLQ C30)
时间窗: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
Quality of life score was calculated according to the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ C30), the range is 0-100, higher scores mean a worse outcome.
Quality of life score QLQ-HN35
时间窗: at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
Quality of life score was calculated according to the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire QLQ-HN35, the range is 0-100, higher scores mean a worse outcome.
次要结局
- Changes in fear of recurrence(at inclusion, 6 months,12 months, 24 months, 36 months and 60 months)
- Changes in Depression(at inclusion, 6 months,12 months, 24 months, 36 months and 60 months)
- Changes in self-management(at inclusion, 6 months,12 months, 24 months, 36 months and 60 months)
- Changes in knowledge, skill, and confidence for self-management(at inclusion, 6 months,12 months, 24 months, 36 months and 60 months)
- Changes in anxiety(at inclusion, 6 months,12 months, 24 months, 36 months and 60 months)
- Changes in work ability(at inclusion, 6 months,12 months, 24 months, 36 months and 60 months)
研究者
Qiaojuan Guo
M.D, Professor
Fujian Cancer Hospital