Impact of Telemonitoring for the Management of Side Effects in Patients with Melanoma, Lung or Renal Cancer, Treated with Immunotherapy Combination of Nivolumab and Ipilimumab or Adjuvant Nivolumab Monotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 10
- 主要终点
- Delay between the start of a side effect and reporting to the medical team (average number of days per patient).
研究概览
简要总结
The ipilimumab and nivolumab combination is now part of the standard of care for the treatment of melanoma, renal and lung cancer patients. Grade 3/4 adverse events (AEs) occur in 30 to 60% of patients included in clinical trials. Grade 3/4 AEs are more frequently observed (50-60% of patients) in melanoma because ipilimumab is administrated at 3mg/kg in this population. Among these AEs, early detection of immune related AEs is critical to an adequate medical management. In this context, dedicated tools for remote monitoring of these patients are crucial.
The investigators developed within the Immucare consortium a simplified medical questionnaire which is addressed weekly to the patients. This questionnaire along with an algorithm gives to the clinician regular feedback on their patients' general symptoms. The investigators herein want to evaluate in a randomized prospective trial the efficacy of this remote monitoring to reduce the time between the start of AE and the reporting to the medical team, which could lead to detect and treat earlier AEs induced by nivolumab and ipilimumab in the melanoma, lung and renal cancer patients' population.
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
- •Age > 18 years
- •Patients diagnosed with melanoma, or lung cancer or renal cancer
- •Patients starting a treatment with a combination of immunotherapy of nivolumab + ipilimumab (NB: patients who have already received immunotherapy in the past may be included)
- •Patients comfortable with the use of digital tools and computing
- •Patients who agree to participate to the telemonitoring and signed consent form
排除标准
- •Pregnant, parturient and lactating women
- •Patients under legal protection measure or deprived of their liberty
- •Patients not affiliated to a social security scheme (schemes such as the AME) or beneficiaries of a similar regime (foreign person, outside the EU)
结局指标
主要结局
Delay between the start of a side effect and reporting to the medical team (average number of days per patient).
时间窗: 12 months
The delay between the start of a side effect and medical information will be calculated for each AE and average per patient in each of the two groups studied, with its 95% confidence interval.The delays of the two groups will be compared using a Mann-Whitney test.
次要结局
- Number of unplanned hospitalizations(12 months)
- Number of treatment interruptions and number of days of treatment delays interruptions, number of treatment discontinuation, number of dose reductions and and percentage of dose reduction(12 months)
- Number of admissions in the emergency room(12 months)
- Number of AE identified by clinicians(12 months)
- Number of contact with general practitioner(12 months)
- benefit for clinicians: interview of clinicians on their opinion on the self-monitoring, evaluation to the impact on the consultations during the first year of treatment, assessed with satisfaction questionnaires(Month 12)
- Levels of morbidity based on CTC-AE v5 (all toxicities)(12 months)
- Overall quality of Life assessed with standardized QoL questionnaires (FACT-G)(12 months)
- Adherence: The number of full symptoms report completions and adherence to the completion schedule(12 months)