Effect of Multidisciplinary Team Support on Head and Neck Cancer Patients Receiving Radiotherapy: The SHINE-MDT Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 233
- 试验地点
- 1
- 主要终点
- Radiotherapy interruption rate
研究概览
简要总结
Radiotherapy is one of the main treatments for head and neck Carcinoma. The incidence of radiotherapy-related adverse events is greater than 90%, and severe adverse events may lead to the interruption of radiotherapy.
The management of nutritional, psychological, and rehabilitative issues in patients undergoing radiotherapy for head and neck cancer presents unique clinical challenges. We aimed to evaluate the efficacy of the SHINE-MDT (Supportive Holistic Interventions by Nurses and Experts via Multidisciplinary Team) in reducing radiotherapy interruptions and improving patients' quality of life (QoL) compared with usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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 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
结局指标
主要结局
Radiotherapy interruption rate
时间窗: 5 days
Interruption of radiotherapy was defined as the actual end date of radiotherapy minus the expected end date at least 5 days
次要结局
- Quality of life score (EORTC QLQ C30)(Weekly during radiotherapy and the first month post-treatment, and at 2, 3, and 6 months post-treatment)
- Quality of life score QLQ-HN35(Weekly during radiotherapy and the first month post-treatment, and at 2, 3, and 6 months post-treatment)
- Nutritional status (NRS 2002, PG-SGA)(Weekly during radiotherapy and the first month post-treatment, and at 2, 3, and 6 months post-treatment)
- Psychological status (DT, PHQ-9, HADS)(Weekly during radiotherapy and the first month post-treatment, and at 2, 3, and 6 months post-treatment)
研究者
Xingchen Peng
PhD, Professor
West China Hospital