Quality of life after patient-initiated vs physician-initiated response to symptom monitoring: the SYMPRO-Lung trial

Abstract

Background: Previous studies using patient-reported outcomes measures (PROMs) to monitor symptoms during and after (lung) cancer treatment used alerts that were sent to the health-care provider, although an approach in which patients receive alerts could be more clinically feasible. The primary aim of this study was to compare the effect of weekly PROM symptom monitoring via a reactive approach (patient receives alert) or active approach (health-care provider receives alert) with care as usual on health-related quality of life (HRQOL) at 15 weeks after start of treatment in lung cancer patients.

Methods: The SYMPRO-Lung trial is a multicenter randomized controlled trial using a stepped wedge design. Stage I-IV lung cancer patients in the reactive and active groups reported PROM symptoms weekly, which were linked to a common alerting algorithm. HRQOL was measured by the EORTC QLQ-C30 at baseline and after 15 weeks. Linear regression analyses and effect size estimates were used to assess mean QOL-C30 change scores between groups, accounting for confounding.

Results: A total of 515 patients were included (160 active group, 89 reactive group, 266 control group). No differences in HRQOL were observed between the reactive and active group (summary score: unstandardized beta [B] = 0.51, 95% confidence interval [CI] = -3.22 to 4.24, Cohen d effect size [ES] = 0.06; physical functioning: B = 0.25, 95% CI = -5.15 to 4.64, ES = 0.02). The combined intervention groups had statistically and clinically significantly better mean change scores on the summary score (B = 4.85, 95% CI = 1.96 to 7.73, ES = 0.57) and physical functioning (B = 7.00, 95% CI = 2.90 to 11.09, ES = 0.71) compared with the control group.

Conclusions: Weekly PRO symptom monitoring statistically and clinically significantly improves HRQOL in lung cancer patients. The logistically less intensive, reactive approach may be a better fit for implementation.

Figure 1.

Set of predefined conditions that prompted the web application to create an alert. PRO-CTCAE = Patient-Reported Outcomes–Common Terminology Criteria for Adverse Events.

Figure 2.

CONSORT diagram of the Symptom Reporting with Patient-Reported Outcomes–Lung trial.

Figure 3.

Proportion of patients with health-related quality of life changes at 15 weeks (T1) compared with baseline. For the clinically relevant change in physical functioning Cock et al. (33) guidelines for within-group changes were used: improvements: medium >7, small 7-2; no difference or trivial 2 to -5; deteriorations: small -5 to -10, medium -10 to -17, large <-17. P values were calculated using Pearson χ² tests comparing the control group vs the intervention group.