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临床试验/NCT04324437
NCT04324437已完成不适用

eRAPID: Electronic Monitoring of Patient-reported Symptoms in Patients With a Diagnosis of Thoracic Cancer Managed at Leeds Cancer Centre

University of Leeds2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2020年7月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
43
试验地点
2
主要终点
Acceptability of intervention to patients

研究概览

简要总结

Lung cancer is a leading cause of cancer-related ill-health and death in the United Kingdom (UK), but with advances in systemic anti-cancer therapies the prognosis for people in later stages is improving. There is growing evidence that electronic systems which enable patients to monitor and report symptoms can help improve symptom control and patient care. This study aims to investigate optimal ways of introducing an electronic symptom reporting system (eRAPID) in lung cancer care at Leeds Cancer Centre. eRAPID was developed by the University of Leeds and its integration with the electronic health records at Leeds Cancer Centre enables staff to view patient symptom reports directly. eRAPID provides advice to patients about self-management of milder symptoms, for serious symptoms patients are encouraged to contact the hospital and an alert is sent to the nurse or doctor by email.

The aim of the study is to assess the feasibility and usefulness of an electronic symptom reporting system (eRAPID) for lung cancer patients and healthcare professionals during the treatment of lung cancer and during one year follow up.

Two groups of patients will be recruited on the basis of their access to the internet at home (rather than randomisation). It is anticipated that approximately 100 patients will enrol into one of two groups:

  • Group 1: Patients with online access at home will be asked to report weekly using their own devices.
  • Group 2: Patients without online access will be asked to report on a tablet computer before their planned clinic appointments.

The eRAPID questionnaire is based on existing eRAPID items with the addition of new items specific to lung cancer. These have been developed by the clinical team and patient groups have been consulted over the suitability of the wording used.

Analysis of patient reported symptoms, quality of life and clinical information will be descriptive. Disease-related symptoms and health-related quality of life will be compared across groups of patients with a diagnosis of lung cancer. Treatment-related side effects of patients will be compared across the different types of treatment received. To determine the best means of engaging patients in systematic electronic reporting, the recruitment and compliance rate will be compared between the two patient groups. The utility of patient reported information to healthcare staff will be assessed through staff interviews.

详细描述

Background: Lung cancer is a leading cause of cancer-related morbidity and mortality. There are 2 main categories of lung cancer: non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). NSCLC accounts for approximately 85% of lung cancer diagnoses, almost 70% of NSCLC cases are diagnosed in the advanced/metastatic stages (IIIB-IV) of the disease. Pleural mesothelioma is another rare form of lung cancer, the average incidence across European countries is 20 cases per million people. Historically, patients with NSCLC were treated with the same algorithm, without consideration of their histological sub-type or their molecular profile. More recently, personalised therapies based on histology and/or molecular pathology have become the standard of care. The stage of NSCLC determines treatment options, with surgery being the mainstay of treatment for patients in early stages of the disease (stages I-IIIA). Additionally, those with localised disease spread (stages II and IIIA) may receive adjuvant therapy [11]. In patients with advanced/metastatic disease (stages IIIB-IV) and a performance status (PS) score of 0-2, the first line treatment options include chemotherapy regimens with or without immunotherapy or targeted biological therapy.

Patient reported outcome measures (PROMs) encompass data self-reported by patients about how they feel and function and include symptoms, physical function, emotional distress and health-related quality of life (HRQoL). PROMs are becoming important for patient care, as they provide the means of recording the experience of the patient in a structured format readily available to relevant clinical staff. Recently a randomised control trial (RCT) in advanced lung cancer using web-mediated follow-up showed overall survival benefit of 7-9 months compared to usual care, whilst maintaining cost-effectiveness. The relapses were detected earlier in patients in the intervention arm facilitating earlier and appropriate treatment initiation compared to patients in the control arm.

Study aims: This study will systematically capture patient reported disease-related symptoms, treatment-related side effects and HRQoL in a cohort of patients treated with systemic anti-cancer therapy (SACT) for thoracic cancer. The objectives are:

  1. To compare disease-related symptoms and HRQoL across groups of patients stratified by patient and clinical characteristics.
  2. To compare treatment-related side effects of patients prescribed chemotherapy, tyrosine kinase inhibitors (TKIs) or checkpoint inhibitors.
  3. To compare outcomes, such as healthcare resource utilisation (HCRU), in patients systematically self-reporting symptoms
  4. To examine patient acceptance, feasibility of this approach and optimal means of engaging with patients in the systematic PROMs reporting in a real world setting.
  5. To assess the utility of PROMs reported by patients to their healthcare professionals.

Study design: This is an interventional, prospective study conducted at a single cancer centre. Patients with a diagnosis of thoracic cancer prescribed SACT will be enrolled in the study at oncology clinic visits. The intervention is an electronic patient self-report of disease-related symptoms, treatment-related side effects and HRQoL. This design allows the assessment of the utility to clinicians of PROMs reporting in the real world setting and provides an opportunity to study customised patient interventions based on PROMs reporting.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • Diagnosis of thoracic cancer: Non-small cell lung cancer (NSCLC), or Small cell lung cancer (SCLC), or Pleural mesothelioma
  • Start of a systemic anti-cancer therapy with prescribed chemotherapy, tyrosine kinase inhibitors (TKIs) or checkpoint inhibitors within the recruitment period
  • Willing and able to provide written informed consent
  • Fluency in English

排除标准

  • Cognitive impairment
  • Receiving best-supportive care only

结局指标

主要结局

Acceptability of intervention to patients

时间窗: 6 months and 12 months

Interim and end of study interviews with patients

Number of participants recruited/number of patients approached (consent rate)

时间窗: Baseline

Number of patients approached and recruited will be logged during recruitment

Number of participant withdrawals

时间窗: 12 months

Number of participant withdrawals will be logged at the time of withdrawal

Use of the intervention

时间窗: 6 month and 12 months

Number of self-reported symptom monitoring reports and quality of life questionnaires completed

Use of hospital services (triage calls, acute admissions, ward stays)

时间窗: 12 months

Descriptive statistics overall and completion modality

Changes to supportive medication, treatment doses and planned therapy

时间窗: 12 months

Descriptive statistics overall and completion modality

Number of adverse event reports, severe adverse event alerts and patient deaths

时间窗: 12 months

Descriptive statistics by cancer type, treatment and completion modality

Reason for participant withdrawal

时间窗: 12 months

Reasons for withdrawal will be captured in CRF at time of withdrawal

Acceptability of intervention to clinicians

时间窗: 6 months and 12 months

Interim and end of study interviews with clinicians

Integrity of the system

时间窗: 6 months and 12 months

Technical issues logged during the study

Proportion of missing data in symptom reports and quality of life questionnaires

时间窗: 12 months

Regular completions of symptom reports (either weekly or per scheduled clinical and quality of life questionnaires completed 12 weekly by participants

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Galina Velikova

Professor

University of Leeds

研究点 (2)

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