NCT03073031已完成不适用
The Use of PRO-CTCAE by Patients Receiving Immunotherapy for the Treatment of Malignant Melanoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- The number of patients who experience drug-related grade 3 or 4 adverse events assessed by CTCAE 4.0 will be reduced by 50% in the intervention arm compared to patients in the control arm
研究概览
简要总结
This study evaluates if melanoma patients who report their side effects to immunotherapy weekly by the use of ePRO-CTCAE will experience an overall reduction of grade 3 and 4 events with 50% compared to routine monitoring carried out every 3 weeks.
详细描述
Hypothesis:
- Melanoma patients who report their side effects to immunotherapy by the use of PRO-CTCAE (Common Terminology Criteria for Adverse Events) will experience an overall reduction of grade 3 and 4 events with 50% compared to routine monitoring.
Aim:
- Primary endpoint: To examine if the electronic tool PRO-CTCAE used on a weekly basis by patients receiving immunotherapy to supplement standard AE monitoring, results in cutting the frequency of grade 3 or 4 adverse events during treatment by 50% compared to patients who get a standard AE monitoring schedule every 3 weeks.
- Secondary endpoints: 1)To examine if the time patients experience grade 2 or higher toxicity, differs in the two groups 2)To examine if more symptoms are reported in the intervention group 3) To examine if there is a difference between the 2 group when it comes to number of extra out-patient visits, days in hospital, telephone consultations and days in prednisone therapy 4) To examine if PRO-CTCAE is implementable in daily practice (will be explored in study 2 and 3).
- Exploratoty endpoint: To examine, using both qualitative and quantitative data, patients´ and clinicians´ experiences with the e-Health intervention to monitor side effects during treatment with immunotherapy in routine clinical practice.
Method:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Men and women ≥18 years of age
- •who read and understand Danish,
- •who have been diagnosed with malignant melanoma,
- •who are about to be treated with immunotherapy for their disease (1st and 2nd line, mono-therapy and combination therapy).
- •Moreover, patients must have signed and dated a written informed consent form in accordance with regulatory and institutional guidelines and 6) be willing and able to comply with the completion of PRO-CTCAE and other required questionnaires.
排除标准
- 未提供
结局指标
主要结局
The number of patients who experience drug-related grade 3 or 4 adverse events assessed by CTCAE 4.0 will be reduced by 50% in the intervention arm compared to patients in the control arm
时间窗: The first 6 months of treatment with immunotherapy
次要结局
- The number of drug-related adverse events assessed by CTCAE 4.0 reported in the intervention will be higher compared to the adverse events reported in the control arm(The first 6 months of treatment with immunotherapy)
- Patients in the intervention arm have a longer progression free survival compared to patients in the control arm(Estimation of median PFS and progression free survival rate at 6, 12 and 24 months)
- Patients in the intervention arm have a better QoL compared to patients in the control arm(baseline, week 24 and week 48)
- The time patients experience grade 2 or higher toxicity assessed by CTCAE, differs in the intervention arm and the control arm respectively(The first 6 months of treatment with immunotherapy)
- The number of contacts to the hospital will be higher in the intervention arm compared to patients in the control arm(The first 6 months of treatment with immunotherapy)
- The number of hospitalizations are fewer in the intervention arm compared to the control arm.(The first 6 months of treatment with immunotherapy)
- Patients in the intervention arm have a longer overall survival compared to patients in the control arm(Estimation of median OS and overall survival rate at 6, 12 and 24 months)
- Patients in the intervention arm receive a lower accumulated prednisone dose compared to patients in the control arm(The first 6 months of treatment with immunotherapy)
- The QoL of patients who experience grade 3 or 4 irAEs vs. no grade 3 or 4 irAEs(baseline, week 24 and week 48)
研究者
Laerke Kjaer Tolstrup
Principal investigator
Odense University Hospital
研究点 (2)
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