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
- 招募中
- 入组人数
- 130
- 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
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