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Randomized Controlled Trial
. 2024 Nov;13(22):e70325.
doi: 10.1002/cam4.70325.

Nurse-Led Screening-Triggered Early Specialized Palliative Care Program for Patients With Advanced Lung Cancer: A Multicenter Randomized Controlled Trial

Yoshihisa Matsumoto  1   2 , Shigeki Umemura  3 , Ayumi Okizaki  1   4   5 , Daisuke Fujisawa  6 , Takuhiro Yamaguchi  7 , Shunsuke Oyamada  7   8 , Tempei Miyaji  5   9 , Tomoe Mashiko  5 , Naoko Kobayashi  10 , Eriko Satomi  11 , Daisuke Kiuchi  11   12 , Tatsuya Morita  13 , Yosuke Uchitomi  4   5 , Koichi Goto  3 , Yuichiro Ohe  14
Affiliations
Randomized Controlled Trial

Nurse-Led Screening-Triggered Early Specialized Palliative Care Program for Patients With Advanced Lung Cancer: A Multicenter Randomized Controlled Trial

Yoshihisa Matsumoto et al. Cancer Med. 2024 Nov.

Abstract

Background: We aimed to examine the effectiveness of a nurse-led, screening-triggered early specialized palliative care intervention program for patients with advanced lung cancer.

Methods: Patients with advanced lung cancer who underwent initial chemotherapy were randomized to intervention and usual care groups between January 2017 and September 2019. The intervention comprised comprehensive needs assessments, counseling, and service coordination by advanced-level nurses. Patients in the usual care group received the usual oncological care. The primary end point was a change in the trial outcome index (TOI) scores from baseline to 12 weeks. The secondary end-points were TOI scores at week 20, depression, anxiety, and survival.

Results: In total, 102 patients were assigned to each group. Compared with the usual care group, no significant improvement in TOI scores was observed at 12 weeks in the intervention group (mean group difference: 2.13; 90% confidence interval: -0.70, 4.95; p = 0.107, one-sided), whereas significant improvement was observed at 20 weeks (3.58; 90% confidence interval: 0.15, 7.00; p = 0.043). There were no significant differences in the change from baseline depression and anxiety between the groups from baseline at week 12 and 20 weeks (depression: p = 0.60 and 0.10, anxiety: p = 0.78 and 0.067). Survival did not significantly differ between the groups (median survival time: 12.1 vs. 11.1 months; p = 0.302).

Conclusions: Nurse-led, screening-triggered, early specialized palliative care did not show significant superiority over usual care during the 12-week study period. However, it may have yielded delayed clinical benefits, such as improved quality of life and this feasible model can be acceptable in clinical practice.

Trial registration: The University Hospital Medical Information Network Clinical Trials Registry: UMIN000025491.

Keywords: advanced lung cancer; nurse‐led program; palliative care; quality of life; randomized controlled trial; screening.

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Conflict of interest statement

Dr. Matsumoto reported grants from the Japan Agency for Medical Research and Development (AMED) (Grants JP16ck0106213 and JP19ck0106502) and the Japan Health, Labour and Welfare Sciences Research Grants (Grant of H27‐Cancer Control‐general‐002). No other disclosures were reported.

Figures

FIGURE 1
FIGURE 1
CONSORT flow diagram.
FIGURE 2
FIGURE 2
Result of primary analysis (Change from baseline). TOI, trial outcome index.
FIGURE 3
FIGURE 3
Overall survival.
See this image and copyright information in PMC

References

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