SYMptom monitoring with Patient-Reported Outcomes using a web application among patients with Lung cancer in the Netherlands (SYMPRO-Lung):Study protocol for a stepped-wedge randomised controlled trial

Introduction Lung cancer and its treatment cause a wide range of symptoms impacting the patients’ health-related quality of life (HRQoL). The use of patient-reported outcomes (PRO) to monitor symptoms during and after cancer treatment has been shown not only to improve symptom management but also to improve HRQoL and overall survival (OS). Collectively, these results favour implementation of PRO-symptom monitoring in daily clinical care. However, these promising outcomes have been obtained under trial conditions in which patients were selected based on stringent inclusion criteria, and in countries with a dissimilar healthcare system than in the Netherlands. The primary aim of the SYMptom monitoring with Patient-Reported Outcomes using a web application among patients with Lung cancer in the Netherlands (SYMPRO-Lung) study is to evaluate the effect of PRO-symptom monitoring during and after lung cancer treatment on HRQoL in daily clinical practice. Secondary objectives include assessing the effect of PRO-symptom monitoring on progression-free survival, OS, the incidence and grade of PRO symptoms, medication adherence, implementation fidelity and cost-effectiveness. Methods and analysis The SYMPRO-Lung study is a prospective, multicentre trial with a stepped wedge cluster randomised design. Study participants (n=292 intervention, n=292 controls) include patients with lung cancer (stages I–IV) starting treatment with surgery, systemic treatment, targeted treatment and/or radiotherapy. Every participating centre will consecutively switch from the control period to the intervention period, in which patients report their symptoms weekly via an online tool. In the intervention group, we evaluate two alert approaches: the active and reactive approach. If the symptoms exceed a predefined threshold, an alert is sent to the healthcare provider (active approach) or to the patient (reactive approach). Both the control and intervention group complete HRQoL questionnaires at 4 time points: at baseline, 15 weeks, 6 months and 1-year post treatment). Differences in HRQoL between the groups will be compared using linear mixed modelling analyses, accounting for within-centre clustering, potential time effects and confounding. Ethics and dissemination The study protocol was approved by the Institutional Review Board and the Medical Ethics Committee of the Amsterdam UMC (under number NL 68440.029.18) and the institutional review boards of the participating study sites. The dissemination of the results will be conducted through publication in peer-reviewed journals and through scientific conferences. Trial registration number Trial register identifier: Netherlands Trial register Trial NL7897. Date of registration: 24 July 2019. https://www.trialregister.nl/trial/7897

Selecting a Subset Based on the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events for Patient-Reported Symptom Monitoring in Lung Cancer Treatment: Mixed Methods Study

BackgroundThe Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) item library covers a wide range of symptoms relevant to oncology care. There is a need to select a subset of items relevant to specific patient populations to enable the implementation of PRO-CTCAE–based symptom monitoring in clinical practice. ObjectiveThe aim of this study is to develop a PRO-CTCAE–based subset relevant to patients with lung cancer that can be used for monitoring during multidisciplinary clinical practice. MethodsThe PRO-CTCAE–based subset for patients with lung cancer was generated using a mixed methods approach based on the European Organization for Research and Treatment of Cancer guidelines for developing questionnaires, comprising a literature review and semistructured interviews with both patients with lung cancer and health care practitioners (HCPs). Both patients and HCPs were queried on the relevance and impact of all PRO-CTCAE items. The results were summarized, and after a final round of expert review, a selection of clinically relevant items for patients with lung cancer was made. ResultsA heterogeneous group of patients with lung cancer (n=25) from different treatment modalities and HCPs (n=22) participated in the study. A final list of eight relevant PRO-CTCAE items was created: decreased appetite, cough, shortness of breath, fatigue, constipation, nausea, sadness, and pain (general). ConclusionsOn the basis of the literature and both professional and patient input, a subset of PRO-CTCAE items has been identified for use in patients with lung cancer in clinical practice. Future work is needed to confirm the validity and effectiveness of this PRO-CTCAE–based lung cancer subset internationally and in real-world clinical practice settings

Translation of the eHealth Impact Questionnaire for a Population of Dutch Electronic Health Users: Validation Study

BACKGROUND: The eHealth Impact Questionnaire (eHIQ) provides a standardized method to measure attitudes of electronic health (eHealth) users toward eHealth. It has previously been validated in a population of eHealth users in the United Kingdom and consists of 2 parts and 5 subscales. Part 1 measures attitudes toward eHealth in general and consists of the subscales attitudes towards online health information (5 items) and attitudes towards sharing health experiences online (6 items). Part 2 measures the attitude toward a particular eHealth application and consists of the subscales confidence and identification (9 items), information and presentation (8 items), and understand and motivation (9 items). OBJECTIVE: This study aimed to translate and validate the eHIQ in a Dutch population of eHealth users. METHODS: The eHIQ was translated and validated in accordance with the COnsensus-based Standards for the selection of health status Measurement INstruments criteria. The validation comprised 3 study samples, with a total of 1287 participants. Structural validity was assessed using confirmatory factor analyses and exploratory factor analyses (EFAs; all 3 samples). Internal consistency was assessed using hierarchical omega (all 3 samples). Test-retest reliability was assessed after 2 weeks, using 2-way intraclass correlation coefficients (sample 1). Measurement error was assessed by calculating the smallest detectable change (sample 1). Convergent and divergent validity were assessed using correlations with the remaining measures (all 3 samples). A graded response model was fit, and item information curves were plotted to describe the information provided by items across item trait levels (all 3 samples). RESULTS: The original factor structure showed a bad fit in all 3 study samples. EFAs showed a good fit for a modified factor structure in the first study sample. This factor structure was subsequently tested in samples 2 and 3 and showed acceptable to good fits. Internal consistency, test-retest reliability, convergent validity, and divergent validity were acceptable to good for both the original as the modified factor structure, except for test-retest reliability of one of the original subscales and the 2 derivative subscales in the modified factor structure. The graded response model showed that some items underperformed in both the original and modified factor structure. CONCLUSIONS: The Dutch version of the eHIQ (eHIQ-NL) shows a different factor structure compared with the original English version. Part 1 of the eHIQ-NL consists of 3 subscales: attitudes towards online health information (5 items), comfort with sharing health experiences online (3 items), and usefulness of sharing health experiences online (3 items). Part 2 of the eHIQ-NL consists of 3 subscales: motivation and confidence to act (10 items), information and presentation (13 items), and identification (3 items)

SYMptom monitoring with Patient-Reported Outcomes using a web application among patients with Lung cancer in the Netherlands (SYMPRO-Lung): Study protocol for a stepped-wedge randomised controlled trial

Introduction Lung cancer and its treatment cause a wide range of symptoms impacting the patients’ health-related quality of life (HRQoL). The use of patient-reported outcomes (PRO) to monitor symptoms during and after cancer treatment has been shown not only to improve symptom management but also to improve HRQoL and overall survival (OS). Collectively, these results favour implementation of PRO-symptom monitoring in daily clinical care. However, these promising outcomes have been obtained under trial conditions in which patients were selected based on stringent inclusion criteria, and in countries with a dissimilar healthcare system than in the Netherlands. The primary aim of the SYMptom monitoring with Patient-Reported Outcomes using a web application among patients with Lung cancer in the Netherlands (SYMPRO-Lung) study is to evaluate the effect of PRO-symptom monitoring during and after lung cancer treatment on HRQoL in daily clinical practice. Secondary objectives include assessing the effect of PRO-symptom monitoring on progression-free survival, OS, the incidence and grade of PRO symptoms, medication adherence, implementation fidelity and cost-effectiveness. Methods and analysis The SYMPRO-Lung study is a prospective, multicentre trial with a stepped wedge cluster randomised design. Study participants (n=292 intervention, n=292 controls) include patients with lung cancer (stages I–IV) starting treatment with surgery, systemic treatment, targeted treatment and/or radiotherapy. Every participating centre will consecutively switch from the control period to the intervention period, in which patients report their symptoms weekly via an online tool. In the intervention group, we evaluate two alert approaches: the active and reactive approach. If the symptoms exceed a predefined threshold, an alert is sent to the healthcare provider (active approach) or to the patient (reactive approach). Both the control and intervention group complete HRQoL questionnaires at 4 time points: at baseline, 15 weeks, 6 months and 1-year post treatment). Differences in HRQoL between the groups will be compared using linear mixed modelling analyses, accounting for within-centre clustering, potential time effects and confounding. Ethics and dissemination The study protocol was approved by the Institutional Review Board and the Medical Ethics Committee of the Amsterdam UMC (under number NL 68440.029.18) and the institutional review boards of the participating study sites. The dissemination of the results will be conducted through publication in peer-reviewed journals and through scientific conferences. Trial registration number Trial register identifier: Netherlands Trial register Trial NL7897. Date of registration: 24 July 2019. https://www.trialregister.nl/trial/7897