Pilot Study - Measurement of Cost, Outcome and Patient Experience of a Digital Weekly Follow up of Lung Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Assess the response rates on the digital weekly questionnaire
研究概览
简要总结
In the pilot study, 30 patients with metastatic lung cancer (stage IV) will be recruited at the start of their stage IV treatment from February 2019. The study period per patient will last six months, from the start of the stage IV treatment. Patients are eligible if they are diagnosed with stage IV lung cancer, speak sufficient Dutch, and are willing to participate. Patients are randomly assigned to two arms by simple randomization. In the intervention arm, 15 patients will receive a weekly questionnaire. Alerts will be sent to the multidisciplinary care team, who will undertake follow-up actions. In the control arm, 15 patients will receive the standard care pathway without weekly questionnaire and without automatic alerts to the care team. The standard care pathways and the care team are the same in both groups. In this pilot study, the weekly follow-up will be evaluated by a validation questionnaire, semi-structured interviews with patients (n=5) and the care team (n=5), and workload registration of the care team during a six-month period for all included patients in the pilot.
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
- •stage IV lung cancer,
- •speak sufficient Dutch
- •willing to participate
排除标准
- 未提供
研究组 & 干预措施
intervention arm
In the intervention arm, 15 patients will receive a weekly questionnaire. Alerts will be sent to the multidisciplinary care team, who will undertake follow-up actions. In the control arm, 15 patients will receive the standard care pathway without weekly questionnaire and without automatic alerts to the care team. The standard care pathways and the care team are the same in both groups. In this pilot study, the weekly follow-up will be evaluated by a validation questionnaire, semi-structured interviews with patients and the care team, and workload registration of the care team during a six-month period.
干预措施: Weekly digital follow up (Device)
Control arm
结局指标
主要结局
Assess the response rates on the digital weekly questionnaire
时间窗: up to 26 weeks
In the weekly digital questionnaire the patient reports adverse events and psychosocial support needs. Based on this questionnaire alerts are generated to the care team
Assess the Response on the validation questionnaire at Baseline and at Week 26
时间窗: up to 26 weeks
In the validation questionnaire the patient evaluates the online system, the relevance and difficulty of the questions
Assess the workload of responding to the alerts on the weekly questionnaire for the care team
时间窗: up to 26 weeks
the workload is assessed by daily registration of the workload (in minutes) per patient during the six-month registration period by the care team: 2 MD pulmonologists, oncology nurse, psychologist, palliative support, and dietician
Assess the clinical utility of the alerts for the care team
时间窗: month 6
In semi-structured interviews with the multidisciplinary care team, the clinical utility of receiving and responding to alerts is assessed with every care giver: an MD pulmonologist, oncology nurse, psychologist, palliative support, and dietician
次要结局
- Validation questionnaire(month 6)
- Weekly questionnaire based on PRO CTC-AE(up to 26 weeks)
- EORTC QLQ-C30(week 24)
- QLQ-LC13(week 24)
研究者
prof. dr. Wim Marneffe
Principal Investigator
Hasselt University