Abstract 1234TiP
Background
Lung cancer and its treatment induce a wide range of symptoms and side effects. These symptoms have a significant impact on patients’ health related quality of life (HRQoL). Recently, several trials have shown that the use of patient reported outcomes (PROs) for monitoring these complaints can improve symptom management, HRQoL and overall survival (OS). Potential underlying mechanisms for these results include early responsiveness to symptoms. PRO monitoring can ensure that relevant symptoms are assessed and acted upon in a timely manner. The results depict a potential role for PRO symptom monitoring applications in daily lung cancer clinical practice.
Trial design
In this study we will research the use of an online app, based on a subset from the Patient Reported Outcomes Version of the Common Toxicity Criteria for Adverse Events (PRO-CTCAE), for lung cancer patients to monitor their symptoms over time that are clinically relevant. A scoring algorithm is used to assess the severity of the symptoms. If symptoms exceed a predefined threshold an alert is sent by e-mail to the health care practitioner (active intervention) or to the patient (reactive intervention). The study uses a stepped wedge design. Over a period of 16 months, thirteen hospitals consecutively switch form the control period to the intervention. Participating hospitals are randomized between either active or reactive monitoring of symptoms. Patient recruitment and data collection started in October 2019. Inclusion criteria are existing or newly diagnosed (non-)small cell lung cancer stage I-IV, starting treatment with radiotherapy, surgery, chemotherapy, immunotherapy and/or targeted therapy. 584 patients will be recruited into the study. The primary aim of the study is to compare the effect of PRO symptom monitoring with usual care on HRQoL both during (at 15 weeks and 6 months) and up to 1 year after start of treatment. Secondary aims are studying the effect of the app compared to usual care on incidence and grade of symptoms, progression and OS, medication adherence and cost effectiveness. Additionally, we will analyze non-inferiority between the active and reactive intervention and implementation fidelity.
Clinical trial identification
Netherlands Trial register Trial NL7897. Date of registration: July 24, 2019.
Editorial acknowledgement
Legal entity responsible for the study
Amsterdam University Medical Center, Location VUmc.
Funding
Zorg Innovatiefonds, Stichting Kwaliteitsgelden Medisch Specialisten and Roche.
Disclosure
All authors have declared no conflicts of interest.