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Abstract：
BACKGROUND: 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.
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
BACKGROUND: ClinicalTrials.gov NCT04616768; https://clinicaltrials.gov/study/NCT04616768.
UNASSIGNED: RR2-10.1136/bmjopen-2021-054675.
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
BACKGROUND: ClinicalTrials.gov NCT04616768; https://clinicaltrials.gov/study/NCT04616768.
UNASSIGNED: RR2-10.1136/bmjopen-2021-054675.
摘要：
背景：接受化疗的晚期癌症患者会出现明显的症状和功能状态下降，这与糟糕的结果有关。远程监测患者报告的结果（PRO；症状）和步数（功能状态）可以主动识别有住院或死亡风险的患者。
目的：本研究的目的是评估（1）纵向PRO与步数的关系以及（2）PRO和步数与住院或死亡的关系。
方法：PROStep随机试验纳入了108名在大型学术癌症中心接受细胞毒性化疗的晚期胃肠道或肺癌患者。患者被随机分配到每周基于文本的8个PRO监测，以及通过Fitbit（Google）与常规护理进行连续步数监测。这项预先计划的二次分析包括75例随机分配到干预措施的患者中的57例，这些患者具有PRO和步数数据。我们使用自举广义线性模型来解释纵向数据，分析了PRO和平均每日步数之间的关联以及PRO和步数与住院或死亡的复合结局之间的关联。
结果：在57例患者中，平均年龄为57（SD10.9）岁，24名（42%）为女性，43（75％）患有晚期胃肠道癌，14人（25%）患有晚期肺癌，25例(44%)在随访期间住院或死亡.PRO总分每周增加1分（32分）与平均每日步数减少247个相关（95％CI-277至-213；P<.001）。与步数下降最密切相关的是患者报告的活动（每日步数变化-892），恶心评分（-677），和便秘评分（524）。综合PRO评分每周增加1分与住院或死亡几率增加20%相关(调整后比值比[aOR]1.2,95%CI1.1-1.4;P=0.01)。与住院或死亡最密切相关的是疼痛(aOR3.2,95%CI1.6-6.5;P<.001),活性降低(AOR3.2，95%CI1.4-7.1；P=0.01)，呼吸困难（aOR2.6，95%CI1.2-5.5；P=0.02），和悲伤（aOR2.1，95%CI1.1-4.3；P=0.03）。1000步的减少与16％的住院或死亡几率相关（aOR1.2，95％CI1.0-1.3；P=0.03）。与基线相比，平均每日步数减少7%(n=274步)，9%(n=351步)，16％（n=667步）在住院或死亡前3、2和1周，分别。
结论：在一项针对晚期癌症患者的随机试验的二次分析中，较高的症状负担和步数减少与住院或死亡独立相关,且可预测的恶化程度接近住院或死亡.未来的干预措施应利用纵向PRO和步数数据，以针对有不良结局风险的患者进行干预。
背景：ClinicalTrials.govNCT04616768;https://clinicaltrials.gov/study/NCT04616768。
■RR2-10.1136/bmjopen-2021-054675。
目的：本研究的目的是评估（1）纵向PRO与步数的关系以及（2）PRO和步数与住院或死亡的关系。
方法：PROStep随机试验纳入了108名在大型学术癌症中心接受细胞毒性化疗的晚期胃肠道或肺癌患者。患者被随机分配到每周基于文本的8个PRO监测，以及通过Fitbit（Google）与常规护理进行连续步数监测。这项预先计划的二次分析包括75例随机分配到干预措施的患者中的57例，这些患者具有PRO和步数数据。我们使用自举广义线性模型来解释纵向数据，分析了PRO和平均每日步数之间的关联以及PRO和步数与住院或死亡的复合结局之间的关联。
结果：在57例患者中，平均年龄为57（SD10.9）岁，24名（42%）为女性，43（75％）患有晚期胃肠道癌，14人（25%）患有晚期肺癌，25例(44%)在随访期间住院或死亡.PRO总分每周增加1分（32分）与平均每日步数减少247个相关（95％CI-277至-213；P<.001）。与步数下降最密切相关的是患者报告的活动（每日步数变化-892），恶心评分（-677），和便秘评分（524）。综合PRO评分每周增加1分与住院或死亡几率增加20%相关(调整后比值比[aOR]1.2,95%CI1.1-1.4;P=0.01)。与住院或死亡最密切相关的是疼痛(aOR3.2,95%CI1.6-6.5;P<.001),活性降低(AOR3.2，95%CI1.4-7.1；P=0.01)，呼吸困难（aOR2.6，95%CI1.2-5.5；P=0.02），和悲伤（aOR2.1，95%CI1.1-4.3；P=0.03）。1000步的减少与16％的住院或死亡几率相关（aOR1.2，95％CI1.0-1.3；P=0.03）。与基线相比，平均每日步数减少7%(n=274步)，9%(n=351步)，16％（n=667步）在住院或死亡前3、2和1周，分别。
结论：在一项针对晚期癌症患者的随机试验的二次分析中，较高的症状负担和步数减少与住院或死亡独立相关,且可预测的恶化程度接近住院或死亡.未来的干预措施应利用纵向PRO和步数数据，以针对有不良结局风险的患者进行干预。
背景：ClinicalTrials.govNCT04616768;https://clinicaltrials.gov/study/NCT04616768。
■RR2-10.1136/bmjopen-2021-054675。
