Supporting endocrine therapy adherence in women with breast cancer: findings from the ROSETA pilot fractional factorial randomized trial.

IF 3.6 2区心理学 Q1 PSYCHOLOGY, MULTIDISCIPLINARY

Annals of Behavioral Medicine Pub Date : 2025-01-04 DOI:10.1093/abm/kaaf003

Samuel G Smith, Sophie M C Green, Emma McNaught, Christopher D Graham, Robbie Foy, Pei Loo Ow, David P French, Louise H Hall, Hollie Wilkes, Christopher Taylor Ba, Rachel Ellison, Erin Raine, Rebecca Walwyn, Daniel Howdon, Jane Clark, Nikki Rousseau, Jacqueline Buxton Ba, Sally J L Moore, Jo Waller, Catherine Parbutt, Galina Velikova, Amanda Farrin, Michelle Collinson

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引用次数: 0

Abstract

Background: Adherence to adjuvant endocrine therapy (AET) in women with breast cancer is poor. Multicomponent intervention packages are needed to address adherence barriers. Optimizing these packages prior to definitive evaluation can increase their effectiveness, affordability, scalability, and efficiency.

Purpose: To pilot procedures for an optimization-randomized controlled trial (O-RCT) of the 'Refining and Optimizing Strategies to support Endocrine Therapy Adherence' (ROSETA) intervention.

Methods: This was a multisite individually randomized external pilot trial using a 24-1 fractional factorial design (ISRCTN10487576). Breast cancer survivors prescribed AET were recruited from 5 hospitals and randomized to one of 8 conditions, each comprising a combination of 4 intervention components set to "on" or "off" (SMS messages, information leaflet, guided self-help, and self-management website). We set criteria to inform the decision to progress to an O-RCT for consent rate, component adherence, and availability of outcome measures, with predefined cutoffs for "green" (proceed), "amber" (minor changes), and "red" (major changes).

Results: Among 141 eligible patients, 54 (38.3%) consented (green range). At least 50.0% of participants adhered to the minimum threshold set for each intervention component (green range). Data for one of the 3 medication adherence measures were available (amber range). Most (86.8%) participants were satisfied with their trial experience. Exploratory analysis indicated some evidence of a negative main effect of the information leaflet on medication adherence (adjusted mean difference = 0.088, 95% CI, 0.018, 0.158).

Conclusions: Progression to a fully powered O-RCT of the ROSETA intervention package is feasible, but review of medication adherence measures is required.

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支持乳腺癌妇女的内分泌治疗依从性：来自rosetta试点部分因子随机试验的发现

背景：乳腺癌患者对辅助内分泌治疗（AET）的依从性较差。需要多组分干预方案来解决依从性障碍。在确定评估之前优化这些包可以提高它们的有效性、可负担性、可伸缩性和效率。目的：为“改进和优化支持内分泌治疗依从性的策略”（rosetta）干预的优化随机对照试验（O-RCT）的程序进行试点。方法：这是一项采用24-1分数因子设计的多站点单独随机外部先导试验（ISRCTN10487576）。从5家医院招募处方AET的乳腺癌幸存者，并随机分为8种情况，每种情况由4个干预组成部分组成，分别为“开”或“关”（短信、信息传单、指导自助和自我管理网站）。我们设置了标准，以告知是否进行O-RCT的决定，包括同意率、成分依从性和结果测量的可用性，并预先定义了“绿色”（继续）、“琥珀色”（轻微变化）和“红色”（主要变化）的截止值。结果：在141例符合条件的患者中，54例（38.3%）同意（绿色范围）。至少50.0%的参与者遵守了每个干预成分（绿色范围）设定的最低阈值。3种药物依从性测量中有一种的数据可用（琥珀色范围）。大多数（86.8%）参与者对他们的试验体验感到满意。探索性分析显示，有证据表明信息单张对药物依从性有负向主效应（调整后平均差异= 0.088,95% CI, 0.018, 0.158）。结论：进展到rosetta干预方案的全功率O-RCT是可行的，但需要对药物依从性措施进行审查。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Annals of Behavioral Medicine PSYCHOLOGY, MULTIDISCIPLINARY-

CiteScore

7.00

自引率

5.30%

发文量

期刊介绍： Annals of Behavioral Medicine aims to foster the exchange of knowledge derived from the disciplines involved in the field of behavioral medicine, and the integration of biological, psychosocial, and behavioral factors and principles as they relate to such areas as health promotion, disease prevention, risk factor modification, disease progression, adjustment and adaptation to physical disorders, and rehabilitation. To achieve these goals, much of the journal is devoted to the publication of original empirical articles including reports of randomized controlled trials, observational studies, or other basic and clinical investigations. Integrative reviews of the evidence for the application of behavioral interventions in health care will also be provided. .