An Integrated Digital PROM-platform for Cancer Patients During the COVID-19 Pandemic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 4
- 主要终点
- Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
研究概览
简要总结
During the COVID-19 pandemic, patients with cancer are subject to multiple risks (e.g. frequent hospital visits, increased infection risk, more severe clinical course, discontinued cancer treatment etc.).
Patients undergoing cancer therapy are also faced with several Quality of Life - impairing side effects. In the case of a positive COVID-19 cancer patient, the need and intensity of treating must be weighed against the possible higher risk of developing severe complications in the course of a COVID-19 infection. Nevertheless, both for COVID-19 positive and negative patients who will continue or discontinue cancer treatment throughout the pandemic, providing supportive care is more important than ever.
Digitally monitoring patient-reported outcome measures (PROMs) could offer a solution to improve the supportive care measures during cancer treatment, and certainly in times of COVID-19. Digitalized PROMS could significantly contribute to improved communication, patient satisfaction, supportive care, monitoring of cancer treatment, and detection of problems.
To date, clinical trials investigating the benefits of digital PROMS in patients with cancer during the current COVID-19 pandemic are lacking.
At the Jessa Hospital, the investigators already have experience in collecting PROMs via a digital platform (Awell Health) since 2019 for patients with breast cancer undergoing chemotherapy using validated QoL questionnaires.
The overall aim of this project is to prospectively evaluate the impact of a COVID-19 infection on the severity of the cancer therapy-related complications and the QoL of patients with cancer undergoing chemotherapy using a digital PROMs-platform.
详细描述
General aim: The overall aim of this project is to prospectively evaluate the impact of a COVID-19 infection on the severity of the cancer therapy-related complications and the QoL of patients with cancer undergoing chemotherapy using a digital PROMs platform.
Objective 1: Evaluate the effect of a COVID-19 infection on the severity of cancer therapy-related side effects and patients' QoL
Rationale: The functionality of this platform will be based on three main principles:
- The digital PROMs platform will provide patient-tailored information throughout the course of their disease and up to one month after the end of their chemotherapy concerning complications and COVID-19. This will support the cancer patients during their disease with specific advice based on the side effects they document. First, this will help comfort patients and reduce their anxiety and insecurity in these stressful times. Second, they will receive information regarding measures they can take to tackle their specific complications. Third, this will encourage patients to seek help in case of a possible COVID-19 infection and/or severe side effects by contacting the oncological support team or their physician.
- The platform will prospectively collect QoL data using validated patient-reported questionnaires and specific COVID-19 questionnaires via a mobile application.
- The platform will be fully integrated into the electronic health record (EHR) of the patient and will provide a structured report of the questioned complications for the physician. This will allow the medical oncologist to monitor the medical journey of the patient during and up to one month after their chemotherapy. As such, the medical oncologist can finetune the cancer treatment and supportive care measures towards the needs of the patient.
Hypothesis: "An COVID-19 infection will aggravate the severity of the cancer therapy-related complications and thereby diminish the patients' QoL."
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Diagnosed with any type of cancer (except breast cancer)
- •Undergoing or starting chemotherapy with or without surgery
- •Age ≥ 18 years
- •Access to the online application via computer or smartphone
- •Able to comply with the study protocol
- •Able to sign written informed consent in the digital AWELL platform
- •Provide a signed informed consent
排除标准
- •Diagnosed with breast cancer and undergoing chemotherapy (patients are already included in the healthcare path breast at Jessa Hospital)
- •Undergoing other therapies (e.g. immunotherapy, radiotherapy, targeted therapy, hormonal therapy)
- •Insufficient understanding of the Dutch language
- •Severe cognitive impairment
结局指标
主要结局
Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
时间窗: 1 month post-chemotherapy
Questionnaire to evaluate the presence and severity of therapy-related side effects
Patient satisfaction
时间窗: 1 month post-chemotherapy
Questionnaire to evaluate their general satisfaction and the user friendliness of the digital platform and how it improved their supportive care
Covid-19 triage questionnaire
时间窗: 1 month post-chemotherapy
Questionnaire to screen patients for the possibility of a COVID-19 infection.
COVID-19 questionnaire
时间窗: Fourteenth day after positive COVID-19 test
Questionnaire about symptom burden related to COVID-19
5-level EQ-5D version (EQ5D5L)
时间窗: 1 month post-chemotherapy
Questionnaire to evaluate patients' health-related quality of life on five different levels
COVID-19 Peritraumatic Distress Index (CPDI)
时间窗: 1 month post-chemotherapy
Questionnaire to capture the frequency of specific phobias and stress disorders relevant to COVID-19, including anxiety, depression, specific phobias, cognitive change, avoidance and compulsive behavior, physical symptoms and loss of social functioning
次要结局
未报告次要终点