Randomized Clinical Trial of Telenursing for Monitoring Supportive Care Needs in Patients With Lung Cancer and Melanoma Candidates for the First Prescription of Targeted Therapies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Evaluate the effectiveness of the nursing intervention.
研究概览
简要总结
Single-center, randomized clinical trial (RCT) with low intervention level (Telenursing), for the monitoring of patients affected by lung cancer and melanoma who are candidates for first prescription with Targeted Therapies. The study population will consist of patients suffering from lung cancer and melanoma. The objective of the study will be to evaluate the effectiveness of a Telenursing intervention, comparing the mean score of the total SCNs scale (Supportive Care Needs) after one month of treatment in the treatment arm and in the control arm.
Enrolled patients will then be randomized into two treatment arms:
- Arm 1 (Control Group): current clinical practice
- Arm 2 (Experimental group): Telenursing intervention.
详细描述
To cope with the welfare limits imposed from the SARS-CoV2 pandemic, the specialists of the I.R.C.C.S. Hospital Physiotherapy Institutes (IFO) of Rome have increased the use of telemedicine and have started teleassistance projects in various fields, especially in the nursing field.
The study: single-centre, randomized clinical trial (RCT) with a low level of intervention (Telenursing), for the monitoring of patients affected by lung cancer and melanoma who are candidates for first prescription with Targeted Therapies.
In particular:
Patients enrolled in arm 1 will follow clinical practice with in presence visits and paper based questionnaire and tools, filled daily and periodically (1, 3, 6 months)
Patients in arm 2 will use the Intelligence2health platform for telenursing interventions. For data collection, questionnaires on Google Forms will be used for the acquisition and control of data entered daily and periodically (1, 3, 6 months) by patients. A dedicated company telephone line for short communications will also be available to patients.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged between 18 and 75;
- •patients suffering from lung cancer and melanoma candidates for the first prescription with Targeted Therapies in exclusive treatment;
- •patients able to understand, speak Italian and join the study by signing of paper informed consent;
- •possibility of accessing and using the information technologies adopted in trial through a PC/tablet and personal internet connection;
- •patients willing to comply with study procedures.
排除标准
- •patients not suffering from lung cancer or melanoma;
- •patients already treated or currently being treated with Targeted Therapies, or other treatment (chemotherapy and/or radiotherapy and/or exclusive palliative care);
- •patients with cognitive problems, psychiatric disorders and poor compliance who could interfere with study participation.
结局指标
主要结局
Evaluate the effectiveness of the nursing intervention.
时间窗: 6 month
Evaluate the effectiveness of the Telenursing nursing intervention by comparing the average score after one month of treatment on the total SCN (Supportive Care Needs) scale in the treatment arm and in the control arm, using the Supportive Care Needs monitoring form, to the measurement of adverse events using the 1-5 Likert scale - filled in by clinicians and by research nurses during the monthly in-person visit, according to the Common Terminology Criteria for Adverse Events (CTCAE).
次要结局
- Evaluate the incidence and severity of Adverse Events.(6 months)
- Need for supportive care(6 months)