Self-reported Health During Adjuvant Immunotherapy for Locally Advanced Lung Cancer - the ImmLungCare Project.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Changes in aspects of Quality of life (totalscore and subscale scores) during oncological treatment measured with the questionnaire EORTC QLQ C30.
研究概览
简要总结
Current oncological treatment for patients with locally advanced lung cancer comprise adjuvant immunotherapy (immune checkpoint inhibitors-ICI) as an additional one-year treatment after chemoradiotherapy which increases overall survival and progression-free survival. Patients with lung cancer have a high burden of distressful symptoms at diagnosis and during chemoradiotherapy. Side-effects from immunotherapy differs, they are unspecific and may develop at any point during treatment. However, it is not investigated thoroughly during adjuvant treatment in locally advanced lung cancer. As new oncological treatments are being introduced, focus must be placed on patients quality of life and how patients endure treatment to be able to know how to best support patients during this treatment. The knowledge gained from this project include how adjuvant immunotherapy treatment impacts health. This knowledge is sparse due to the novelty of the treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 with locally advanced non-small lung cancer
- •cared for at either one of two specialized oncology centres
- •≥ 18 years of age
- •planned for concurrent chemoradiotherapy including ICI for 12 months
- •performance status 0-2.
排除标准
- •diseases or comorbidities that may have significant impact on the outcome variables
- •limited understanding of the Swedish language preventing the possibility to give oral and written informed consent.
研究组 & 干预措施
Patients with locally advanced lung cancer cared for at two specialized oncology centres.
Inclusion criteria: locally advanced lung cancer, ≥ 18 years of age, planned for concurrent chemoradiotherapy including ICI for 12 months and performance status 0-2.
结局指标
主要结局
Changes in aspects of Quality of life (totalscore and subscale scores) during oncological treatment measured with the questionnaire EORTC QLQ C30.
时间窗: From enrollment before oncological treatment up til 18 months after start of treatment
Changes between baseline and 12 months after start of immunotherapy will be assessed with the European Organisation for Research and Treatment of Cancer Quality of life scale (EORTC QLQ-C30). The 30 item instrument measure quality of life in patients with cancer. Scores range from 0-100 where a higher score represents higher quality of life.
次要结局
- Changes in self-reported health during oncological treatment measured with EQ-VAS.(From enrollment before oncological treatment up til 18 months after start of treatment)
- Changes in Quality of life specifically in patients with lung cancer during oncological treatment measured with the questionnaire EORTC QLQ - LC13.(From enrollment before oncological treatment up til 18 months after start of treatment)
- Changes in well-being related to immune checkpoint modulators during oncological treatment measured with the questionnaire FACT-ICM.(From enrollment before oncological treatment up til 18 months after start of treatment)
- Changes in existensial health during oncological treatment measured with the questionnaire FACIT-Sp-12.(From enrollment before oncological treatment up til 18 months after start of treatment)
- Changes in health promoting factors during oncological treatment assessed with SOC-13.(From enrollment before oncological treatment up til 18 months after start of treatment)
研究者
Sofie Jakobsson
Associated professor
Göteborg University