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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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. .