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临床试验/NCT03608410
NCT03608410已完成不适用

ProWide - Patient Reported Outcomes Used for Weekly Internet-based DEtection of Progressive Disease in Lung Cancer; a Randomized Controlled Trial

Regional Hospital West Jutland2 个研究点 分布在 1 个国家目标入组 494 人开始时间: 2018年9月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
494
试验地点
2
主要终点
Overall survival

研究概览

简要总结

This randomized controlled trial (RCT) will test if weekly supplementary internet-based self-monitoring of 12 core symptoms can increase survival in Danish lung cancer patients during follow-up or maintenance treatment. A threshold mechanism will automatically send an alert to the hospital in case of alarming or worsening symptoms and the patient will be contacted by the treating clinicians.

详细描述

This multicenter RCT study enrolls patients diagnosed with stage IV og incurable stage III lung cancer who has non-progressive disease at first evaluation scan. Patients in follow-up or maintenance therapy are eligible.

492 patients will be included in the study with 246 patients in each group.

Intervention In the experimental arm, patients will be asked to fill in a web-based Patient Reported Outcome (PRO) questionnaire every week. If one of the reported symptoms worsens and exceed a predefined threshold of severity, a notification is automatically sent to the hospital. A nurse will review til questionnaire and contact the patient for verification of symptoms. If progression of disease is suspected, a CT scan will be made. Otherwise, the nurse will schedule a visit at the clinic for physical examination and evaluation by a clinician. If progressive disease is not suspected, supportive care will be adjusted and the patient will continue follow up according to the usual schedule.

The interventions ends in case of progressive disease.

Evaluation Baseline CT-scan of thorax and upper abdomen is performed prior to initial treatment and an evaluation CT scan at the time of enrolment. CT scans will be repeated for assessing signs of progression due to standard follow-up procedures in both groups. If progressive disease is suspected based on symptom development, the following scan will be rescheduled to as soon as possible.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
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

入选标准

  • Patients with lung cancer (NSCLC and SCLC), who have received 1st line induction treatment* for lung cancer and have no sign of progressive disease at first evaluation CT scan.
  • Patients diagnosed with stage III treated with palliative intention, and stage IV, regardless of treatment intention.
  • Diagnosis proven by cytology or histology
  • Age ≥ 18 years
  • Performance status (PS) ≤ 2 within 15 days before enrolment
  • First evaluation CT scan performed within four weeks from enrolment
  • Patient with acess to internet, Mobile phone and E-boks (Danish digital secure mail system)
  • Patient has given his/her written informed consent before any specific procedure from protocol
  • Induction treatment includes:
  • Standard doublet chemotherapy
  • Immunotherapy
  • Targeted therapy
  • Palliative radiotherapy
  • Local treatment of oligometastatic disease, including surgery and stereotactic radiotherapy
  • Any combination of the above-mentioned treatment modalities Patients are eligible regardless of whether they at the time of inclusion continue maintenance treatment or not

排除标准

  • Progressive disease at first evaluation scan
  • Persons deprived of liberty or under guardianship or curators
  • Dementia, mental alteration or psychiatric disease that can compromise informed consent from the patient and / or adherence to the protocol and the monitoring of the trial
  • Pregnant or breastfeeding women
  • Patient participating in another interventional study during the surveillance period. This is only relevant for studies that might interfere with the intervention. Participation in protocols related only to treatment will not preclude participation in the present study. Cases of doubt will be settled by the protocol committee.

结局指标

主要结局

Overall survival

时间窗: 2 years

次要结局

  • Progression free survival(2 years)
  • Quality of life measured by EORTC QLQ C30/LC13.(2 years)
  • Baseline questionnaires of non-participants(2 years)
  • Type of treatment at time of progression(2 years)
  • HADS score (Hospital Anxiety And Depression Scale)(2 years)
  • Quality of life (QOL) measured by EuroQol EQ-5D-5L.(2 years)
  • ECOG (Eastern Cooperative Oncology Group) Performance status at time of progression(2 years)
  • Qualitative interviews(2 years)

研究者

发起方
Regional Hospital West Jutland
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rasmus Blechingberg Friis

MD, Principal Investigator

Regional Hospital West Jutland

研究点 (2)

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