Web-based Symptom Monitoring and Survival in Advanced Stage Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 398
- 主要终点
- Overall survival
研究概览
简要总结
The goal of this clinical trial is to investigate if weekly symptom monitoring of patients with advanced lung cancer is associated with better survival and improved quality of life compared to standard follow-up.
Each week, participants in the intervention group will be asked to respond to an electronic weekly questionnaire covering 11 items related to current health status.
详细描述
This is a prospective, multicentre, randomized, two-armed, open-label trial in which participants will be randomised to standard follow-up according to current management guidelines for lung cancer (control arm) or with the addition of weekly web-based symptom monitoring (intervention arm). Both study groups will be asked to fill out quality of life questionnaires before randomisation and every three months. In addition to comparing survival and quality of life, the study will also assess progression free survival, performance status, eligibility for second line anti-neoplastic treatment and health care consumption.
All subjects will be followed for 24 months. Updated data on survival will also be collected up to 5-years.
By innovative use of an IT platform already in use in Swedish cancer care, this trial will evaluate potential benefits of systematic symptom monitoring in patients with advanced lung cancer. If corroborating earlier reports of marked survival benefits, the results of this trial could change clinical practice and current guidelines for follow-up of lung cancer 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
- 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
- 否
入选标准
- •Histologically or cytology proven non-small cell lung cancer (NSCLC)
- •NSCLC stage III or IV
- •≥ 18 years
- •ECOG performance status 0- 2
- •Eligible patients should have initiated first-line treatment for advanced or metastatic disease with chemotherapy and/or immunotherapy, radiochemotherapy or targeted treatment
- •Patients are eligible for inclusion if they have responded to first-line treatment with stable disease, or better, at the first radiological evaluation performed up to six months after start of treatment
- •Stable disease, or better, on radiological assessment within 28 days of enrolment (CT scan or FDG-PET/CT. Cerebral MRI if known brain metastasis)
- •Initial web-based application score of ≤ 6
- •Basic computer literacy
- •Bank-ID (electronic identification system) and access to "1177 Vårdguiden"
- •The subject has given written consent to participate in the study
排除标准
- •Symptomatic brain metastases
- •Pregnancy, breastfeeding, or planned pregnancy
- •Persons under guardianship or deprived of liberty
- •Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation
- •Treatment or disease which, according to the investigator, can affect treatment or study results
- •Ongoing participation in another interventional clinical study
结局指标
主要结局
Overall survival
时间窗: From date of randomization until the date of death from any cause, assessed up to 60 months.
Overall survival
次要结局
- Proportion of patients starting second-line anti-neoplastic treatment(Assessed up to 24 months.)
- Progression free survival(From date of randomization until the date of first confirmed disease progression as judged by the investigator, assessed up to 24 months.)
- Performance status(At baseline and at each clinical visit (approximately every 3-4 months), assessed up to 24 months.)
- Symptoms of depression(At baseline and every three months, assessed up to 24 months.)
- Quality of life(At baseline and every three months, assessed up to 24 months.)
- Number of days of in-hospital care(Assessed up to 24 months.)
研究者
Mats Lambe
Professor
Karolinska University Hospital