Effectiveness of a nurse-led, screening-triggered, early specialized palliative care intervention program for patients with advanced lung cancer: A multicenter randomized controlled trial.
Authors: Matsumoto Yoshihisa , Okizaki Ayumi , Kiuchi Daisuke , Umemura Shigeki , Yamaguchi Takuhiro , Oyamada Shunsuke , Fujisawa Daisuke , Kobayashi Naoko , Miyaji Tempei , Mashiko Tomoe , Satomi Eriko , Uehara Yuko , Kosugi Kazuhiro , Kinoshita Hiroya , Mori Masanori , Yoshida Tatsuya , Goto Koichi , Ohe Yuichiro , Uchitomi Yosuke , Morita Tatsuya 
Published: June 2021

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Background: The integration of palliative care into standard cancer treatment during the early phase of the disease can improve cancer patients’ quality of life (QOL). The current study examined the effectiveness of a nurse-led, screening-triggered, early specialized palliative care intervention program for patients (pts) with advanced lung cancer. Methods: Pts with advanced lung cancer undergoing initial chemotherapy were randomized (1:1) to the intervention group (IG) or the usual care group (UG) between January 2017 and September 2019. The intervention, which was triggered using by a brief, self-administered screening tool, comprised comprehensive need assessments, counseling, and service coordination by advanced-leveled nurses. The primary endpoint was the change from baseline of the Functional Assessment of Cancer Therapy -Lung Trial Outcome Index (TOI) at week 12, and the secondary endpoints were TOI at week 20, depression (Patient Health Questionnaire-9), anxiety (Generalized Anxiety Disorder-7), and survival. Results: Pts were randomly allocated (102 for each group). The median age was 69 y (range, 27-91) and 77.5% were male. Seventy-two pts had extensive disease small-cell lung carcinoma and 132 Pts had stage IV non-small cell lung carcinoma. Because there was not a significant time-by-group interaction, we estimated main effects and the IG did not show a significant improvement in TOI from the baseline at week 12 and 20 compared to the UG (Mean group difference [the same applies hereafter] 2.13; 90% CI: -0.70, 4.95; P =.107, one-tailed). However, when we considered time-by-group interaction effects exploratorily, the IG did show significant improvement in TOI from baseline at week 20 compared to the UG (3.58; 90% CI: 0.15, 7.00; P = 0.043). There was no significant difference in change from baseline depression and anxiety between the two groups either at week 12 (depression −0.38; 95% CI: -1.81, 1.05; P = 0.60, anxiety -0.18; 95% CI: -1.45, 1.09; P = 0.78) or at week 20 (depression -1.27; 95% CI: -2.79, 0.25; P =.10, 1.26; 95% CI: -2.61, 0.09; P =.067). The 1-year survival rates were 49.5% (95% CI: 39.3, 58.9) in the IG and 43.4% (95% CI: 33.6, 52.8) in the UG. Conclusions: This trial failed to show statistical superiority of nurse-led, screening-triggered, early specialized palliative care intervention program over usual care, however, it’s possible delayed clinical benefits of improvement in QOL (TOI), depression and anxiety were suggested. The study design that some pts in the IG received later or no intervention, may dilute the difference of intervention between group differences. Further investigation, including the mixed method approach adopted in this study, is needed to uncover mediating factors for the effect of this low-cost, novel model of early palliative care. Clinical trial information: UMIN000025491.