A mobile supportive care app for patients with metastatic lung cancer: the Lung Cancer App (LuCApp) randomized controlled trial.

Abstract

Background: Mobile apps to support the delivery of cancer care are proliferating, often without adequate evidence. Lung Cancer App (LuCApp) is a mobile app developed by researchers, clinicians, and patients to promote real-time monitoring and management of symptoms in patients with lung cancer. We aimed to investigate the effect of LuCApp on health-related quality of life (HRQoL), anxiety and depression, and overall survival up to 24 weeks after pharmacological treatment start, as well as its impact on resource use.

Methods: We recruited adult patients diagnosed with non-resectable lung cancer and eligible for pharmaceutical treatments for a multicenter, randomized, non-blinded, controlled parallel-group trial across four hospitals in Italy. Patients were randomly allocated 1:1 to receive either standard care or LuCApp in addition to standard care. In the LuCApp arm, patients could grade a list of symptoms, triggering alerts to the physicians in case predefined severity thresholds were met. Patients completed a baseline assessment and a set of validated patient-reported outcome measures (PROMs) up to 24 weeks after the beginning of the intervention. The primary outcome was the change in the HRQoL score in the Functional Assessment of Cancer Therapy (Lung) questionnaire in the intention-to-treat population from baseline to 12 weeks.

Findings: Between July 2018 and February 2022, 100 adult patients were enrolled (48 in the intervention arm, and 52 in the control group), before the trial was terminated due to pandemic-related challenges with recruitment. The average score (± SD) of the composite primary endpoint HRQoL changed from 56.3 ± 14.8 and 54.9 ± 12.0 at baseline in LuCApp and control arm respectively, to 55.0 ± 15.9 and 55.9 ± 12.1 at 12 weeks, with no significant between-group difference in the change (- 1.68, 95% CI: - 6.90 to 3.54). The average score of the two groups at 24 weeks was 57.3 ± 14.5 and 54.8 ± 11.9 (mean change difference: - 1.57, 95% CI: - 6.66 to 3.52). Mean difference analysis and multivariable mixed models of the HADS-anxiety score indicated improvement in favor of LuCApp, with higher scores by 1.35 (- 0.25 to 2.94) and 1.52 (- 0.14 to 3.19) at 12 and 24 weeks respectively. There was no significant difference in HADS-Depression and EQ-5D-5L scores between groups at both time points. By the end of the follow-up, 5 and 12 deaths were observed in the LuCApp and standard care group, respectively. The use of resources and related costs were lower among LuCApp patients (€2900 vs €3720), although the difference was not statistically significant (p value = 0.138).

Interpretation: In the Italian context, LuCApp for remote symptom monitoring did not demonstrate improved HRQoL in advanced lung cancer patients compared to standard care.

Trial registration: ClinicalTrials.gov NCT03512015, 15 May 2018.