Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04324437 |
| Other study ID # |
270042 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 20, 2020 |
| Est. completion date |
December 31, 2023 |
Study information
| Verified date |
May 2024 |
| Source |
University of Leeds |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
There will be two cohorts of patients. Cohort 1: Patients with online access at home, able to
report PROMs from a location of their choice, using their own devices (laptop, tablet, smart
phone). They will be requested to report weekly.
1. Cohort 2: Patients without online access who will complete PROMs on a tablet before their
scheduled clinic appointment in a private space at Leeds Cancer Centre (LCC). Reporting
frequency will be governed by frequency of routine clinical visits.
Table 1: SACT prescribed for enrollment in the study Diagnosis Treatment description
NSCLC Platinum-based chemotherapy:
- Carboplatin-based
- Cisplatin-based Non-platinum-based chemotherapy
- Pemetrexed TKIs Immune-checkpoint inhibitors (inc. anti-PDL1)
SCLC Platinum-based chemotherapy:
- Carboplatin-based
- Cisplatin-based Non-platinum-based chemotherapy
Pleural mesothelioma Platinum-based chemotherapy:
- Carboplatin-based
- Cisplatin-based Non-platinum-based chemotherapy
- Pemetrexed
Number of patients: All patients meeting patient selection criteria during the recruitment
period will be invited to participate. Approximately 100 patients are expected to be enrolled
(70 patients with a diagnosis of NSCLC, 20 patients with a diagnosis of SCLC, and 10 patients
with a diagnosis of pleural mesothelioma). This estimation is based on the number of thoracic
cancer patients receiving SACT at LCC, the proportion who relapse, and 75% of eligible
patients enrolling.
Recruitment and study duration: Index date is defined in both cohorts as the initiation of a
line of SACT within the study period. For patients newly diagnosed within the study period,
this will be the initiation of their 1st line of therapy (LoT). For patients diagnosed prior
to the study period, the index date will be initiation of 1st or subsequent LoT. Collecting
baseline PROMs at the start of a LoT allows the analysis of change from baseline in disease-
and treatment-related side effects with each new LoT. If the patient wishes to be enrolled,
they will be trained how to use the system. The formal consent will be completed
electronically and then participant complete baseline questionnaires on the electronic
platform. Recruitment will occur over 12-months with 12-month follow-up. There will be an
interim study review to assess the number of patients enrolled, description of patients
enrolled, systematic PROMs reporting compliance, and interim participant feedback.
Instruments' reporting frequency: Three instruments will be used:
1. eRAPID Patient reported adverse events (PRAE) CTCAE adapted symptom questionnaire for
lung cancer, including disease-related symptoms and treatment-related side effects
2. EORTC Quality of Life Questionnaire (QLQ-C30)
3. EuroQol General Quality of Life questionnaire Cohort 1 Patients (Online access) symptom
questionnaire is to be completed weekly, and the quality of life questionnaires at
baseline and then every 12 weeks over the year.
Cohort 2 Patients' (In clinic access) symptom questionnaire to be completed online before
routine clinic appointment. Type of treatment and frequency of clinics will determine the
frequency of questionnaire completion.
Software: eRAPID uses a web-based questionnaire builder system (QTool) to support the
collection and clinical integration of patients' reports. Algorithmic questionnaire scoring
generates severity-dependent management advice to patients and staff when patients
self-reports using the PRAE CTCAE:
- Patients login to QTool using a unique user name and password, complete the
questionnaires remotely on computers/mobile phones/tablets or on a tablet provided in
clinic at LCC.
- Immediate, tailored advice derived from a series of algorithms is generated in response
to reported symptoms and toxicities.
- If severe symptoms are reported, patients are advised to contact the hospital
immediately and an alert is sent to a member of the clinical team.
- For mild/moderate complications, information about self-managing these issues are
provided in QTool and hyperlinks to more detailed advice on the eRAPID patient websites.
- PROMs are available for patients to view in their QTool login and for clinicians to
review in the individuals' electronic medical record.
Healthcare professionals' and patient feedback: Interviews will be conducted with healthcare
professionals and patients about their views of using the eRAPID system. Five members of
staff will be interviewed (n=3 oncologists, n=2 nurses) twice during the study period to gain
feedback on the usefulness of the eRAPID system in lung cancer care. Approximately 12
patients will be interviewed at different stages of using the system from home or from
clinic.
Clinical variables: Patient characteristics, clinical characteristics, treatment variables
will be captured either prospectively in a study case report form (CRF) or retrospectively by
extracting the data from hospital electronic systems.
Data analysis Baseline demographic and clinical data will be tabulated using frequencies and
summary by age, gender, cancer pathology type, stage and treatments.
Recruitment strategy feasibility will be evaluated by summarising the eligibility and consent
processes. The proportion of patients who meet the eligibility criteria in terms of cancer
site, treatment type and timescale will be reported using information from the electronic
health record. The number of patients completing the adverse events (AE) online vs those in
clinic will be summarised. Where available, reasons for ineligibility and non-participation
in the study will be summarised. Retention during the study, including the number of
participants withdrawing from the study and the timing of and reasons for withdrawal will
also be presented. The number of participants involved at each stage will be summarised
(patients identified, approached, consented, completed symptoms and side effects).
The integrity of systems will be assessed by exploring any technical issues encountered
during the study, summarising the rates of questionnaires not being fully completed (assessed
by incomplete calls or time-outs depending on the system used). Reasons for patients
completing symptoms and side effects in clinic rather than from home will be presented. Time
taken to complete the questionnaires will be summarised using time stamps of start and end of
calls/online sessions.
The numbers of expected and additional AE reports and severe AE alerts generated will be
summarised overall, by cancer type, treatment and completion modality (online vs clinic). The
number of telephone calls to hospital staff, acute admissions, ward stays, contacts with
general practitioner and/or community services (where available) and number of deaths will be
summarised overall and by treatment modality. Changes to supportive medication, treatment
(chemotherapy, immunotherapy, targeted therapies) doses and treatment plans and the
percentage of planned therapy received will be summarised overall and by treatment
modalities. Differences between treatments may be explored using logistic or linear
regression (as appropriate) adjusted for stratification factors. Clinician/staff
acceptability will be explored by content analysis of the interviews and field notes.
