确定从行为干预中受益以提高辅助内分泌治疗依从性的患者亚组：一项随机对照试验。
Identification of patient subgroups who benefit from a behavioral intervention to improve adjuvant endocrine therapy adherence: a randomized-controlled trial.
作者信息
Walsh Emily A, Post Kathryn, Massad Katina, Horick Nora, Antoni Michael H, Penedo Frank J, Safren Steven A, Partridge Ann H, Peppercorn Jeffrey, Park Elyse R, Temel Jennifer S, Greer Joseph A, Jacobs Jamie M
机构信息
Department of Psychology, University of Miami, 5665 Ponce de Leon Blvd, Fifth Floor, Coral Gables, FL, 33146, USA.
Massachusetts General Hospital, Boston, MA, USA.
出版信息
Breast Cancer Res Treat. 2024 Apr;204(3):547-559. doi: 10.1007/s10549-023-07228-z. Epub 2024 Jan 17.
PURPOSE
Adjuvant endocrine therapy (AET) reduces breast cancer morbidity and mortality; however, adherence is suboptimal. Interventions exist, yet few have improved adherence. Patient characteristics may alter uptake of an intervention to boost adherence. We examined moderators of the effect of a virtual intervention (STRIDE; #NCT03837496) on AET adherence after breast cancer.
METHODS
At a large academic medical center, patients taking AET (N = 100; M = 56.1, 91% White) were randomized to receive STRIDE versus medication monitoring. All stored their medication in digital pill bottles (MEMS Caps) which captured objective adherence. Participants self-reported adherence (Medication Adherence Report Scale) at 12 weeks post-baseline. Moderators included age, anxiety, and depressive symptoms (Hospital Anxiety and Depression Scale), AET-related symptom distress (Breast Cancer Prevention Trial Symptom Scale), and AET-specific concerns (Beliefs about Medications Questionnaire). We used hierarchical linear modeling (time × condition × moderator) and multiple regression (condition × moderator) to test the interaction effects on adherence.
RESULTS
Age (B = 0.05, SE = 0.02, p = 0.003) and AET-related symptom distress (B = -0.04, SE = 0.02, p = 0.02) moderated condition effect on self-reported adherence while anxiety (B = -1.20, SE = 0.53, p = 0.03) and depressive symptoms (B = -1.65, SE = 0.65, p = 0.01) moderated objective adherence effects. AET-specific concerns approached significance (B = 0.91, SE = 0.57, p = 0.12). Participants who received STRIDE and were older or presented with lower anxiety and depressive symptoms or AET-related symptom distress exhibited improved adherence. Post hoc analyses revealed high correlations among most moderators.
CONCLUSIONS
A subgroup of patients who received STRIDE exhibited improvements in AET adherence. The interrelatedness of moderators suggests an underlying profile of patients with lower symptom burden who benefitted most from the intervention.
STUDY REGISTRATION
NCT03837496.
目的
辅助内分泌治疗（AET）可降低乳腺癌的发病率和死亡率；然而，其依从性并不理想。虽然存在一些干预措施，但很少有能提高依从性的。患者特征可能会改变促进依从性干预措施的采用情况。我们研究了一种虚拟干预措施（STRIDE；#NCT03837496）对乳腺癌后AET依从性影响的调节因素。
方法
在一家大型学术医疗中心，服用AET的患者（N = 100；平均年龄56.1岁，91%为白人）被随机分为接受STRIDE组和药物监测组。所有患者都将药物储存在数字药瓶（MEMS Caps）中，该药瓶可记录客观的依从性情况。参与者在基线后12周自我报告依从性（药物依从性报告量表）。调节因素包括年龄、焦虑和抑郁症状（医院焦虑抑郁量表）、AET相关症状困扰（乳腺癌预防试验症状量表）以及AET特定担忧（药物信念问卷）。我们使用分层线性模型（时间×条件×调节因素）和多元回归（条件×调节因素）来测试对依从性的交互作用。
结果
年龄（B = 0.05，标准误 = 0.02，p = 0.003）和AET相关症状困扰（B = -0.04，标准误 = 0.02，p = 0.02）调节了条件对自我报告依从性的影响，而焦虑（B = -1.20，标准误 = 0.53，p = 0.03）和抑郁症状（B = -1.65，标准误 = 0.65，p = 0.01）调节了客观依从性的影响。AET特定担忧接近显著水平（B = 0.91，标准误 = 0.57，p = 0.12）。接受STRIDE且年龄较大或焦虑和抑郁症状较低或AET相关症状困扰较低的参与者依从性有所提高。事后分析显示大多数调节因素之间存在高度相关性。
结论
接受STRIDE的一组患者在AET依从性方面有所改善。调节因素的相互关联性表明，症状负担较低的患者群体从该干预措施中获益最大。
研究注册号
NCT03837496。
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