Systematic Nurse-Led Consultations Based on Electronic Patient-Reported Outcome Among Women With Gynecological Cancer During Chemotherapy (The CONNECT Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Change from baseline in Quality of life measured by EORTC QLQ C-30 until 9 months.
研究概览
简要总结
Systematic nurse-led consultations based on electronic patient-reported outcomes (ePRO) will be tested among women with ovarian - and endometrial cancer receiving first-line chemotherapy.
详细描述
Women with ovarian- and endometrial cancer often experiences a high disease and treatment-related physical and psychological burden. Patient-reported outcomes (PRO) have the potential to improve patient-clinician communication, symptom management, involvement, and quality of life. Electronic patient-reported outcomes (ePRO) can facilitate appropriate and continuous symptom monitoring reported by the patients. Nurses are with their holistic approach and their specialized knowledge and experience in a prominent position to address and facilitate symptom-management in a multidisciplinary context.
The overall aim of this study is to develop a model of care for systematic nurse-led consultations based on ePRO facilitating symptom management and to investigate how these consultations can be a part of the multidisciplinary treatment regimen for women with ovarian- and endometrial cancer receiving chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women ≥ 18 years
- •Newly diagnosis of ovarian- or endometrial cancer
- •Scheduled to receive first-line standard chemotherapy
- •Having an active email, internet access and a device
- •Able to understand, read and speak Danish
排除标准
- •Severe cognitive impairments/psychiatric disorder
- •Participating in other interventional clinical trials
研究组 & 干预措施
Intervention group
Intervention: This arm will be assigned to the intervention which will be nurse-led consultations based on electronic patient-reported outcomes. The patients will report ePRO weekly during chemotherapy and the answers will be used proactively in the nurse-led consultations. Nurses will conduct the clinical assessment regarding side effects and management before each cycle of chemotherapy.
干预措施: Nurse-led consultations based on electronic patient-reported outcomes (Other)
Standard care
No intervention. This arm will continue standard clinical practice consisting of clinical assessment regarding side effects and management before each cycle of chemotherapy conducted by physicians.
结局指标
主要结局
Change from baseline in Quality of life measured by EORTC QLQ C-30 until 9 months.
时间窗: Change from baseline to 9 months.
EORTC QLQ C-30, a higher score indicates better quality of life (range 0-100). Measured at four time-points.
次要结局
- Change from baseline in Self-efficacy for managing chronic disease 6-item scale until 9 months.(Change from baseline to 9 months.)
- Common Terminology Criteria for Adverse Events (CTCAE), an objective grading of the patients symptoms.(Before each cycle of chemotherapy, in total 6 cycles. A cycle is 21 days.)
- Change from baseline in disease-specific Quality of life using the EORTC QLQ-OV28 Ovarian Module until 9 months.(Change from baseline to 9 months.)
- Change from baseline in Hospital Anxiety and Depression Scale (HADS) until 9 months.(Change from baseline to 9 months.)
- Change from baseline in disease-specific Quality of life using the EORTC QLQ-EN24 Endometrial Module until 9 months.(9 months; at baseline (0 months), 3, 6 and 9 months.)
研究者
Helle Pappot
Professor, Clinical Oncologist, Consultant, DMSc
Rigshospitalet, Denmark