Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, United States.
Institute for Biomedical Informatics, University of Pennsylvania, Philadelphia, PA, United States.
J Med Internet Res. 2024 May 17;26:e51059. doi: 10.2196/51059.
Patients with advanced cancer undergoing chemotherapy experience significant symptoms and declines in functional status, which are associated with poor outcomes. Remote monitoring of patient-reported outcomes (PROs; symptoms) and step counts (functional status) may proactively identify patients at risk of hospitalization or death.
The aim of this study is to evaluate the association of (1) longitudinal PROs with step counts and (2) PROs and step counts with hospitalization or death.
The PROStep randomized trial enrolled 108 patients with advanced gastrointestinal or lung cancers undergoing cytotoxic chemotherapy at a large academic cancer center. Patients were randomized to weekly text-based monitoring of 8 PROs plus continuous step count monitoring via Fitbit (Google) versus usual care. This preplanned secondary analysis included 57 of 75 patients randomized to the intervention who had PRO and step count data. We analyzed the associations between PROs and mean daily step counts and the associations of PROs and step counts with the composite outcome of hospitalization or death using bootstrapped generalized linear models to account for longitudinal data.
Among 57 patients, the mean age was 57 (SD 10.9) years, 24 (42%) were female, 43 (75%) had advanced gastrointestinal cancer, 14 (25%) had advanced lung cancer, and 25 (44%) were hospitalized or died during follow-up. A 1-point weekly increase (on a 32-point scale) in aggregate PRO score was associated with 247 fewer mean daily steps (95% CI -277 to -213; P<.001). PROs most strongly associated with step count decline were patient-reported activity (daily step change -892), nausea score (-677), and constipation score (524). A 1-point weekly increase in aggregate PRO score was associated with 20% greater odds of hospitalization or death (adjusted odds ratio [aOR] 1.2, 95% CI 1.1-1.4; P=.01). PROs most strongly associated with hospitalization or death were pain (aOR 3.2, 95% CI 1.6-6.5; P<.001), decreased activity (aOR 3.2, 95% CI 1.4-7.1; P=.01), dyspnea (aOR 2.6, 95% CI 1.2-5.5; P=.02), and sadness (aOR 2.1, 95% CI 1.1-4.3; P=.03). A decrease in 1000 steps was associated with 16% greater odds of hospitalization or death (aOR 1.2, 95% CI 1.0-1.3; P=.03). Compared with baseline, mean daily step count decreased 7% (n=274 steps), 9% (n=351 steps), and 16% (n=667 steps) in the 3, 2, and 1 weeks before hospitalization or death, respectively.
In this secondary analysis of a randomized trial among patients with advanced cancer, higher symptom burden and decreased step count were independently associated with and predictably worsened close to hospitalization or death. Future interventions should leverage longitudinal PRO and step count data to target interventions toward patients at risk for poor outcomes.
ClinicalTrials.gov NCT04616768; https://clinicaltrials.gov/study/NCT04616768.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2021-054675.
正在接受化疗的晚期癌症患者会经历明显的症状和功能状态下降，这与不良预后相关。对患者报告的结局（PROs；症状）和步数（功能状态）进行远程监测，可能会主动识别出有住院或死亡风险的患者。
本研究旨在评估（1）纵向 PROs 与步数的关系，以及（2）PROs 和步数与住院或死亡的关系。
PROStep 随机试验纳入了在一家大型学术癌症中心接受细胞毒性化疗的 108 例胃肠道或肺癌晚期患者。患者被随机分为每周通过 Fitbit（Google）接受 8 项 PRO 监测和连续步数监测的干预组和常规护理组。本计划的二次分析包括随机分配到干预组的 75 例患者中的 57 例，这些患者有 PRO 和步数数据。我们使用 bootstrap 广义线性模型分析 PROs 与平均每日步数之间的关联，以及 PROs 和步数与住院或死亡的复合结局之间的关联，以解释纵向数据。
在 57 例患者中，平均年龄为 57（标准差 10.9）岁，24 例（42%）为女性，43 例（75%）患有晚期胃肠道癌症，14 例（25%）患有晚期肺癌，25 例（44%）在随访期间住院或死亡。每周 PRO 总分增加 1 分（32 分制）与平均每日步数减少 247 步相关（95%CI-277 至-213；P<.001）。与步数下降最相关的 PRO 是患者报告的活动（每日步数变化-892）、恶心评分（-677）和便秘评分（524）。每周 PRO 总分增加 1 分与住院或死亡的可能性增加 20%相关（调整后的优势比[aOR]1.2，95%CI 1.1-1.4；P=.01）。与住院或死亡最相关的 PRO 是疼痛（aOR 3.2，95%CI 1.6-6.5；P<.001）、活动减少（aOR 3.2，95%CI 1.4-7.1；P=.01）、呼吸困难（aOR 2.6，95%CI 1.2-5.5；P=.02）和悲伤（aOR 2.1，95%CI 1.1-4.3；P=.03）。步数减少 1000 步与住院或死亡的可能性增加 16%相关（aOR 1.2，95%CI 1.0-1.3；P=.03）。与基线相比，在住院或死亡前的 3、2 和 1 周内，平均每日步数分别减少了 7%（n=274 步）、9%（n=351 步）和 16%（n=667 步）。
在这项针对晚期癌症患者的随机试验的二次分析中，更高的症状负担和较低的步数与接近住院或死亡的不良预后独立相关，并可预测地恶化。未来的干预措施应利用纵向 PRO 和步数数据，将干预目标对准有不良结局风险的患者。
ClinicalTrials.gov NCT04616768；https://clinicaltrials.gov/study/NCT04616768。
国际注册报告标识符（IRRID）：RR2-10.1136/bmjopen-2021-054675。
