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

IF 2.9 2区医学 Q2 ONCOLOGY

Cancer Medicine Pub Date : 2024-11-18 DOI:10.1002/cam4.70325

Yoshihisa Matsumoto, Shigeki Umemura, Ayumi Okizaki, Daisuke Fujisawa, Takuhiro Yamaguchi, Shunsuke Oyamada, Tempei Miyaji, Tomoe Mashiko, Naoko Kobayashi, Eriko Satomi, Daisuke Kiuchi, Tatsuya Morita, Yosuke Uchitomi, Koichi Goto, Yuichiro Ohe

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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

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针对晚期肺癌患者的护士主导型筛查触发式早期专业姑息治疗计划：多中心随机对照试验

背景我们旨在研究由护士主导、筛查触发的早期专业姑息治疗干预计划对晚期肺癌患者的疗效。方法在2017年1月至2019年9月期间，接受初始化疗的晚期肺癌患者被随机分为干预组和常规护理组。干预措施包括由高级护士进行全面的需求评估、咨询和服务协调。常规护理组患者接受常规肿瘤护理。主要终点是试验结果指数（TOI）评分从基线到12周的变化。次要终点是第 20 周的 TOI 评分、抑郁、焦虑和存活率。结果每组共有 102 名患者。与常规护理组相比，干预组在12周时的TOI评分没有明显改善（平均组间差异：2.13；90%置信区间：-0.70，4.95）：-0.70，4.95；P = 0.107，单侧），而在 20 周时观察到显著改善（3.58；90% 置信区间：0.15，7.00；P = 0.043）。在第 12 周和 20 周时，各组抑郁和焦虑与基线相比的变化无明显差异（抑郁：p = 0.60 和 0.10；焦虑：p = 0.78 和 0.067）。两组的存活时间无明显差异（中位存活时间：12.1 个月 vs. 11.1 个月；p = 0.302）。结论在为期12周的研究期间，由护士主导、筛查触发的早期专业姑息治疗并未显示出明显优于常规治疗的效果。然而，它可能会产生延迟性临床益处，如改善生活质量，这种可行的模式在临床实践中是可以接受的。试验注册：大学医院医学信息网临床试验注册：UMIN000025491

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来源期刊

Cancer Medicine ONCOLOGY-

CiteScore

5.50

自引率

2.50%

发文量

907

审稿时长

19 weeks

期刊介绍： Cancer Medicine is a peer-reviewed, open access, interdisciplinary journal providing rapid publication of research from global biomedical researchers across the cancer sciences. The journal will consider submissions from all oncologic specialties, including, but not limited to, the following areas: Clinical Cancer Research Translational research ∙ clinical trials ∙ chemotherapy ∙ radiation therapy ∙ surgical therapy ∙ clinical observations ∙ clinical guidelines ∙ genetic consultation ∙ ethical considerations Cancer Biology: Molecular biology ∙ cellular biology ∙ molecular genetics ∙ genomics ∙ immunology ∙ epigenetics ∙ metabolic studies ∙ proteomics ∙ cytopathology ∙ carcinogenesis ∙ drug discovery and delivery. Cancer Prevention: Behavioral science ∙ psychosocial studies ∙ screening ∙ nutrition ∙ epidemiology and prevention ∙ community outreach. Bioinformatics: Gene expressions profiles ∙ gene regulation networks ∙ genome bioinformatics ∙ pathwayanalysis ∙ prognostic biomarkers. Cancer Medicine publishes original research articles, systematic reviews, meta-analyses, and research methods papers, along with invited editorials and commentaries. Original research papers must report well-conducted research with conclusions supported by the data presented in the paper.