A randomized trial of patient navigation with symptom-monitoring in advanced lung cancer.

Background: Early symptom identification in patients with advanced cancer is crucial to prevent morbidity. Patient navigators can facilitate early workup and therapy, potentially improving outcomes. We hypothesized that combining patient navigators with symptom monitoring would improve quality of life (QoL). Methods: Phase III randomized trial in patients with advanced lung cancer planned for palliative intent therapy. Patients in the intervention arm were paired with a navigator who facilitated workup, provided support, and administered weekly symptom proformas (eight symptoms). The navigator alerted the clinician for any symptom marked, "Severe." The primary endpoint was the change in QoL from baseline to 12 weeks measured by the Functional Assessment of Cancer Therapy-Lung Trial Outcome Index (FACT-L TOI). Results: From Feb to Nov 2022, we enrolled 150 patients; 75 in each arm. The median age was 58 years (IQR, 50-67); 100 (66.7%) were male. There were 35 (23.3%) illiterate patients; performance status (PS) was 1, 2, and 3 in 92 (61.3%), 48 (32%), and 10 (6.7%) patients, respectively. QoL at 12 weeks by FACT-L TOI improved by at least 5 points from baseline in 34 (58.6%) patients in the intervention arm, vs 32 (56.1%) in the standard arm; P=0.788. Mean FACT-L TOI increased by 7.76 points in intervention arm vs 10.85 points in control arm (P=0.257; effect size: -1.41). Mean FACT-L QoL score increased by 7.21 points in intervention group vs 13.68 points in control group; P=0.160; effect size:1.17. The time to initiation of cancer treatment was significantly shorter in the intervention group; median 15 days (IQR, 8 - 22) vs 24 (IQR, 15.3 - 36) in control arm, P < 0.001. The median time to deterioration in PS was 26.5 days (IQR, 11 - 58.3) in intervention arm, compared to 17.5 (IQR, 9.8 - 42.5) in control; P=0.343. There were 46 (61.3%) unplanned hospital/emergency room visits in intervention arm vs 38 (51.4%) in standard arm; P=0.219. Treatment completion rate was 82.5% in intervention arm vs 73.2% in control arm; P=0.219. Median dose intensity was 75% (IQR, 75 - 100) in intervention arm vs 100% (100 - 100) in control; P= 0.022. The proportion of patients with severe symptoms in the navigation arm progressively decreased through the course of the study, from 29 (38%) at baseline, to 8 (10.7%) at week 6, and none at week 12. At a median follow-up of 6.4 months, 6-month OS was 66% (SE, 0.057) vs 68.1% (SE, 0.056) in intervention vs control arms, respectively; P=0.343. Conclusions: Patient navigation and weekly symptom proforma monitoring do not significantly improve QoL in patients with advanced lung cancer. However, patient navigators speed up the initiation of cancer-directed therapy by a median of 9 days, which is both statistically significant and clinically meaningful. Clinical trial information: CTRI/2020/023511.