Abstract：
UNASSIGNED: Adjuvant endocrine therapy (AET) use among women with early-stage, hormone receptor-positive breast cancer reduces the risk of cancer recurrence, but its adverse symptoms contribute to lower adherence.
UNASSIGNED: To test whether remote monitoring of symptoms and treatment adherence with or without tailored text messages improves outcomes among women with breast cancer who are prescribed AET.
UNASSIGNED: This nonblinded, randomized clinical trial (RCT) following intention-to-treat principles included English-speaking women with early-stage breast cancer prescribed AET at a large cancer center with 14 clinics across 3 states from November 15, 2018, to June 11, 2021. All participants had a mobile device with a data plan and an email address and were asked to use an electronic pillbox to monitor AET adherence and to complete surveys at enrollment and 1 year.
UNASSIGNED: Participants were randomized into 3 groups: (1) an app group, in which participants received instructions for and access to the study adherence and symptom monitoring app for 6 months; (2) an app plus feedback group, in which participants received additional weekly text messages about managing symptoms, adherence, and communication; or (3) an enhanced usual care (EUC) group. App-reported missed doses, increases in symptoms, and occurrence of severe symptoms triggered follow-ups from the oncology team.
UNASSIGNED: The primary outcome was 1-year, electronic pillbox-captured AET adherence. Secondary outcomes included symptom management abstracted from the medical record, as well as patient-reported health care utilization, symptom burden, quality of life, physician communication, and self-efficacy for managing symptoms.
UNASSIGNED: Among 304 female participants randomized (app group, 98; app plus feedback group, 102; EUC group, 104), the mean (SD) age was 58.6 (10.8) years (median, 60 years; range, 31-83 years), and 60 (19.7%) had an educational level of high school diploma or less. The study completion rate was 87.5% (266 participants). There were no statistically significant differences by treatment group in AET adherence (primary outcome): 76.6% for EUC, 73.4% for the app group (difference vs EUC, -3.3%; 95% CI, -11.4% to 4.9%; P = .43), and 70.9% for the app plus feedback group (difference vs EUC, -5.7%; 95% CI, -13.8% to 2.4%; P = .17). At the 1-year follow-up, app plus feedback participants had fewer total health care encounters (adjusted difference, -1.23; 95% CI, -2.03 to -0.43; P = .003), including high-cost encounters (adjusted difference, -0.40; 95% CI, -0.67 to -0.14; P = .003), and office visits (adjusted difference, -0.82; 95% CI, -1.54 to -0.09; P = .03) over the previous 6 months compared with EUC participants.
UNASSIGNED: This RCT found that a remote monitoring app with alerts to the patient\'s care team and tailored text messages to patients did not improve AET adherence among women with early-stage breast cancer; however, it reduced overall and high-cost health care encounters and office visits without affecting quality of life.
UNASSIGNED: ClinicalTrials.gov Identifier: NCT03592771.
UNASSIGNED: To test whether remote monitoring of symptoms and treatment adherence with or without tailored text messages improves outcomes among women with breast cancer who are prescribed AET.
UNASSIGNED: This nonblinded, randomized clinical trial (RCT) following intention-to-treat principles included English-speaking women with early-stage breast cancer prescribed AET at a large cancer center with 14 clinics across 3 states from November 15, 2018, to June 11, 2021. All participants had a mobile device with a data plan and an email address and were asked to use an electronic pillbox to monitor AET adherence and to complete surveys at enrollment and 1 year.
UNASSIGNED: Participants were randomized into 3 groups: (1) an app group, in which participants received instructions for and access to the study adherence and symptom monitoring app for 6 months; (2) an app plus feedback group, in which participants received additional weekly text messages about managing symptoms, adherence, and communication; or (3) an enhanced usual care (EUC) group. App-reported missed doses, increases in symptoms, and occurrence of severe symptoms triggered follow-ups from the oncology team.
UNASSIGNED: The primary outcome was 1-year, electronic pillbox-captured AET adherence. Secondary outcomes included symptom management abstracted from the medical record, as well as patient-reported health care utilization, symptom burden, quality of life, physician communication, and self-efficacy for managing symptoms.
UNASSIGNED: Among 304 female participants randomized (app group, 98; app plus feedback group, 102; EUC group, 104), the mean (SD) age was 58.6 (10.8) years (median, 60 years; range, 31-83 years), and 60 (19.7%) had an educational level of high school diploma or less. The study completion rate was 87.5% (266 participants). There were no statistically significant differences by treatment group in AET adherence (primary outcome): 76.6% for EUC, 73.4% for the app group (difference vs EUC, -3.3%; 95% CI, -11.4% to 4.9%; P = .43), and 70.9% for the app plus feedback group (difference vs EUC, -5.7%; 95% CI, -13.8% to 2.4%; P = .17). At the 1-year follow-up, app plus feedback participants had fewer total health care encounters (adjusted difference, -1.23; 95% CI, -2.03 to -0.43; P = .003), including high-cost encounters (adjusted difference, -0.40; 95% CI, -0.67 to -0.14; P = .003), and office visits (adjusted difference, -0.82; 95% CI, -1.54 to -0.09; P = .03) over the previous 6 months compared with EUC participants.
UNASSIGNED: This RCT found that a remote monitoring app with alerts to the patient\'s care team and tailored text messages to patients did not improve AET adherence among women with early-stage breast cancer; however, it reduced overall and high-cost health care encounters and office visits without affecting quality of life.
UNASSIGNED: ClinicalTrials.gov Identifier: NCT03592771.
摘要：
■早期女性使用辅助内分泌治疗（AET），激素受体阳性乳腺癌降低了癌症复发的风险，但其不良症状导致依从性降低。
■测试在有或没有定制短信的情况下对症状和治疗依从性的远程监测是否能改善接受AET处方的乳腺癌女性的预后。
■这是非盲的，根据意向治疗原则进行的随机临床试验(RCT)包括,从2018年11月15日至2021年6月11日,在3个州的14家诊所的大型癌症中心,为患有早期乳腺癌的英语女性开了AET处方.所有参与者都有一个带有数据计划和电子邮件地址的移动设备，并被要求使用电子药盒来监控AET依从性并在注册和1年时完成调查。
■参与者被随机分为3组：（1）应用组，其中参与者收到指导并访问研究依从性和症状监测应用程序6个月;（2）应用程序加反馈组，参与者每周收到关于管理症状的额外短信，坚持,和沟通；或（3）强化常规护理（EUC）组。应用程序报告的错过剂量，症状增加，严重症状的发生引发了肿瘤学团队的随访。
■主要结果是1年，电子药丸盒捕获的AET依从性。次要结果包括从病历中提取的症状管理，以及患者报告的医疗保健利用率，症状负担，生活质量,医生沟通，和自我效能管理症状。
■在随机分配的304名女性参与者中（应用组，98；应用程序加反馈组，102；EUC组，104),平均（SD）年龄为58.6（10.8）岁（中位数，60年；范围，31-83岁），60名(19.7%)的高中文凭或以下。研究完成率为87.5%（266名参与者）。治疗组AET依从性（主要结果）无统计学差异：EUC为76.6％，应用程序组的73.4%(差异与EUC，-3.3%；95%CI，-11.4%至4.9%；P=.43），应用程序加反馈组的70.9%(差异与EUC，-5.7%；95%CI，-13.8%至2.4%；P=.17）。在1年的随访中，应用程序加上反馈参与者的总医疗保健遭遇较少(调整后的差异，-1.23；95%CI，-2.03至-0.43；P=.003），包括高成本的遭遇(调整后的差额，-0.40；95%CI，-0.67至-0.14；P=.003），和办公室访问(调整后的差额，-0.82；95%CI，-1.54至-0.09；P=0.03）与EUC参与者相比，过去6个月。
■此RCT发现，远程监控应用程序向患者的护理团队发出警报，并为患者量身定制短信，并未改善早期乳腺癌女性的AET依从性；然而，它在不影响生活质量的情况下，减少了整体和高成本的医疗保健服务和办公室就诊。
■ClinicalTrials.gov标识符：NCT03592771。
■测试在有或没有定制短信的情况下对症状和治疗依从性的远程监测是否能改善接受AET处方的乳腺癌女性的预后。
■这是非盲的，根据意向治疗原则进行的随机临床试验(RCT)包括,从2018年11月15日至2021年6月11日,在3个州的14家诊所的大型癌症中心,为患有早期乳腺癌的英语女性开了AET处方.所有参与者都有一个带有数据计划和电子邮件地址的移动设备，并被要求使用电子药盒来监控AET依从性并在注册和1年时完成调查。
■参与者被随机分为3组：（1）应用组，其中参与者收到指导并访问研究依从性和症状监测应用程序6个月;（2）应用程序加反馈组，参与者每周收到关于管理症状的额外短信，坚持,和沟通；或（3）强化常规护理（EUC）组。应用程序报告的错过剂量，症状增加，严重症状的发生引发了肿瘤学团队的随访。
■主要结果是1年，电子药丸盒捕获的AET依从性。次要结果包括从病历中提取的症状管理，以及患者报告的医疗保健利用率，症状负担，生活质量,医生沟通，和自我效能管理症状。
■在随机分配的304名女性参与者中（应用组，98；应用程序加反馈组，102；EUC组，104),平均（SD）年龄为58.6（10.8）岁（中位数，60年；范围，31-83岁），60名(19.7%)的高中文凭或以下。研究完成率为87.5%（266名参与者）。治疗组AET依从性（主要结果）无统计学差异：EUC为76.6％，应用程序组的73.4%(差异与EUC，-3.3%；95%CI，-11.4%至4.9%；P=.43），应用程序加反馈组的70.9%(差异与EUC，-5.7%；95%CI，-13.8%至2.4%；P=.17）。在1年的随访中，应用程序加上反馈参与者的总医疗保健遭遇较少(调整后的差异，-1.23；95%CI，-2.03至-0.43；P=.003），包括高成本的遭遇(调整后的差额，-0.40；95%CI，-0.67至-0.14；P=.003），和办公室访问(调整后的差额，-0.82；95%CI，-1.54至-0.09；P=0.03）与EUC参与者相比，过去6个月。
■此RCT发现，远程监控应用程序向患者的护理团队发出警报，并为患者量身定制短信，并未改善早期乳腺癌女性的AET依从性；然而，它在不影响生活质量的情况下，减少了整体和高成本的医疗保健服务和办公室就诊。
■ClinicalTrials.gov标识符：NCT03592771。
