Pilot Study of the eHealth Application 'Cancer Patients Better Life Experience'
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Change in fatigue between baseline and 3 and 6 months, as measured by fatigue symptom scale of The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-core 30 (EORTC QLQ-C30)
研究概览
简要总结
The purpose of this study is to compare health-related quality of life, specifically fatigue, in melanoma patients treated with immunotherapy who use or do not use a patient-centered mobile coaching and monitoring system (CAPABLE). It is expected that by using the CAPABLE eHealth tool, patients' fatigue worsens less significantly (10 points) in the first 3 months follow-up than observed in usual care.
详细描述
This is a prospectively enrolling, explorative cohort study in melanoma patients, eligible for or on treatment with ICI therapy. The explorative cohort receives the CAPABLE smartphone application and a multi-sensorial smartwatch. Patients will be asked to use the system for minimum of three to maximum of six months after enrolment. Questionnaires on health-related quality of life (such as fatigue) and user experience will be administered to the patients on baseline/before start treatment (T0), three months (T1) and six months (T2). Results of this interventional study will be compared with a historical cohort consisting of melanoma patients (P20MEL; NL75996.031.20) with the same inclusion criteria as this study population, but receiving standard care (e.g. without the CAPABLE app).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- •>18 years of age
- •Sufficient understanding of the Dutch language
- •Participants or their caregiver can use a smartphone (upon patient's consent)
- •Histologically confirmed stage III or IV melanoma who receive treatment with immune checkpoint-inhibitors, according to the clinical guidelines.
排除标准
- •Included in a clinical trial
- •>12 months on active treatment
结局指标
主要结局
Change in fatigue between baseline and 3 and 6 months, as measured by fatigue symptom scale of The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-core 30 (EORTC QLQ-C30)
时间窗: Baseline, month 3, month 6
Fatigue is measured on a score from 0-100, the lower the score the less fatigue a patient has
次要结局
- Change in health-related quality of life and QALY's between baseline and 3 and 6 months, as measured by The EuroQoL-5D (EQ-5D-5L).(Baseline, month 3, month 6)
- Change in health-related quality of life and physical symptoms between baseline and 3 and 6 months, as measured by the EORTC QLQ-C30(Baseline, month 3, month 6)
- Patient compliance(Through study completion, an average of 6 months)
- Change in melanoma specific quality of life between baseline and 3 and 6 months, as measured by the FACT-M(Baseline, month 3, month 6)
- Change in patient reported immunotherapy-related toxicity between baseline and 3 and 6 months, as measured by a self-developed questionnaire using EORTC item bank items(Baseline, month 3, month 6)
- Change in psychological distress between baseline and 6 months, as measured by the Hospital Anxiety and Depression Scale (HADS).(Baseline, month 6)
- Change in information satisfaction/needs between baseline and 6 months, as measured by the EORTC QLQ-INFO25(Baseline, month 6)
- Usability/user experience as measured by The System Usability Scale (SUS)(Baseline)
- Usability/user experience as measured by the User Version of the Mobile Application Rating Scale (uMARS)(Month 6)
- Recruitment rate(Through study completion, an average of 6 months)
- Usability/user experience as measured by PAtient Trust Assessment Tool (PATAT)(Month 3)