Trial reportAnnals of behavioral medicine : a publication of the Society of Behavioral Medicine2025
Supporting endocrine therapy adherence in women with breast cancer: findings from the ROSETA pilot fractional factorial randomized trial.
Trial report in Annals of behavioral medicine : a publication of the Society of Behavioral Medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
5 citing papers in PubMed.
- Role of individualized intervention(s) on quality of life and adherence to adjuvant endocrine therapy in premenopausal women with early-stage breast cancer: MyCHOICE study.Breast cancer research and treatment · 2026Trial
- Optimizing Goal Difficulty in a Digital Weight Loss Intervention: The Ignite Pilot Randomized Trial.Obesity science & practice · 2026Article
- Article
- Medication Adherence in Women with Early-Stage Breast Cancer and Active Parenting Responsibilities: The Mediating Role of Parenting Stress and Spiritual Well-Being.Medicina (Kaunas, Lithuania) · 2026Article
- Article
Corrections and comments
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Authors and funding
23 authors.
Funding
Abstract
backgroundAdherence 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.
methodsThis 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).
resultsAmong 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).
conclusionsProgression 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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