"Impact of a Nursing Intervention in the Management of Oncological Patients With Lung Cancer Under Treatment With Immunotherapy"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 4
- 主要终点
- Changes on quality of life in lung cancer patients with immunotherapy treatment measured by EORTC quality of life scale
研究概览
简要总结
Introduction. Lung cancer is very common worldwide with 2.09 million cases in 2018. Immunotherapy has become a mainstay in cancer treatment. There is insuficient knowledge about the impact of altered needs, as well as the interventions developed by the nurse that are aimed at cancer patients in immunotherapy treatment.
Objectives. Describe the needs of non-microcytic lung cancer patients in immunotherapy. And, evaluate the effectiveness of a nurse intervention program aimed at these patients in decreasing comorbidities, increasing satisfaction, early detection of symptoms and management of toxicities, quality of life and monitoring of anthropometric indicators.
Methodology. Phase 1: descriptive, cross-cutting and prospective study. Phase 2: quasi-experimental pre-post study. The sample is patients of the Hospital de la Santa Creu i Sant Pau, with non-microcytic lung cancer in treatment with Checkpoints inhibitor antibodies. The dependent variables: sociodemographic variables, clinical variables, satisfaction, quality of life, nutritional status, psychological impact, toxicities, number of unscheduled visits and health costs. Independent variable: nurse intervention program.
Implications for practice: Knowing the needs of patients in immunotherapy treatment will allow the development of a nurse care program to meet these needs and evaluate the program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- All
- 接受健康志愿者
- 是
入选标准
- •Patient of legal age (> or equal to 18 years), either male or female.
- •Patient diagnosed with lung cancer regardless of subtype and / or stage. Except for small cell lung cancer, since this subtype of lung cancer is very different from the others and requires its own study.
- •Patient receiving immunotherapy regardless of the treatment line.
- •Patient who receives immunotherapy regardless of whether it is monotherapy or combination of chemotherapy.
- •Patient who is able to consent to participate in the study.
- •Patient who can read, understand and can communicate verbally.
排除标准
- •Patient diagnosed with lung cancer synchronously with another neoplasm.
- •Patients with speech disorders.
- •Patients who do not understand or speak Spanish, Catalan or English.
结局指标
主要结局
Changes on quality of life in lung cancer patients with immunotherapy treatment measured by EORTC quality of life scale
时间窗: 6 months
Assess the quality of life of lung cancer patients from before starting immunotherapy up to 6 months after starting it. Through the EORTC QLQ-LC 30.
Number of altered needs of patients with lung cancer undergoing treatment with immunotherapy
时间窗: one day
Detect the altered needs of patients with lung cancer in immunotherapy treatment. In order to outline the best intervention program that suits their needs. Through assessment through scales and questionnaires.
Changes on anxiety in lung cancer patients with immunotherapy treatment measured by Hospital Anxiety and Depression Scale (HADS)
时间窗: 6 months
Assess the patient's level of anxiety from diagnosis and prior to initiating treatment up to 6 months after initiating treatment. Using the Hospital Anxiety and Depression Scale (HADS)
Number of immunomediated toxicities requiring hospital admission
时间窗: 6 months
Record the number and type of toxicities that require hospital admission for its management.
次要结局
- Number of nutritional alterations in patients with lung cancer, who start immunotherapy treatment(6 months)