CN1 - Patient-reported symptom monitoring improves health-related quality of life in lung cancer patients: The SYMPRO-Lung trial

Background

The use of patient reported outcomes measures (PROMs) to monitor symptoms during and after cancer treatment can improve health-related quality of life (HRQOL) and overall survival (OS), especially when linked to an alert system. While previous studies only used alerts that were sent to the health care provider (HCP), an approach in which patients themselves receive alerts could be more clinically feasible. The primary aim of the SYMPRO-Lung study was to compare the effect of weekly online PROM symptom monitoring (intervention group, IG) with care as usual (control group, CG) on HRQOL 15 weeks after start of treatment for lung cancer. We also investigated the effect of a reactive approach (patient receives alert) vs. an active approach (HCP receives alert).

Methods

SYMPRO-Lung is a Dutch multicenter randomized trial using a stepped wedge design. Inclusion criteria were (non-)small cell lung cancer stage I-IV, starting treatment. Patients in the IG reported PRO symptoms weekly using the PRO-CTCAE subset. If symptoms exceeded a validated threshold, an alert was sent. HRQOL was measured by the EORTC QLQ-C30 at baseline and 15 weeks after start of treatment. Linear regression analyses were used to assess differences in HRQOL at 15 weeks, accounting for HRQOL at baseline and confounding. Cohen’s f ² effect sizes (ES) were calculated in which 0.35 was seen as large and clinically relevant.

Results

In total, 515 patients were included in the study (266 control, 249 intervention). In the IG, 244 patients completed 2412 symptom checklists during the first 15 weeks of treatment, M 10 per patient (SD 4.3). A total of 673 alerts (28%) were triggered, M 3 (SD 2.1). The IG had statistically and clinically significant better physical functioning (ES 0.50) and less dyspnea (ES 0.38), as compared to the CG. While the HRQOL overall summary score (ES 0.34), role – (ES 0.31), and social functioning (ES 0.26), fatigue (ES 0.27), and constipation (ES 0.16) were only statistically significant. No significant differences were found in HRQOL between the two intervention groups.

Conclusions

PROM symptom monitoring significantly improves HRQOL in lung cancer patients. The logistically less intensive, reactive approach may be a better fit for some hospitals.

Clinical trial identification

Netherlands Trial Register: Trial NL7897.

Editorial acknowledgement

Legal entity responsible for the study

Amsterdam UMC, location VUmc.

Funding

Roche, Zorg Innovatiefonds, and Stichting Kwaliteitsgelden Medisch Specialisten (SKMS).

Disclosure

C. Van den Hurk: Financial Interests, Institutional, Principal Investigator: AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Merck; Financial Interests, Institutional, Project Lead: Ipsen. All other authors have declared no conflicts of interest.