Smith, S., Green, S. orcid.org/0000-0002-2622-5377, McNaught, E. et al. (20 more authors) (2025) Supporting endocrine therapy adherence in women with breast cancer: findings from the ROSETA pilot fractional factorial randomized trial. Annals of Behavioral Medicine, 59 (1). kaaf003. ISSN 0883-6612
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.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © The Author(s) 2025. This is an open access article under the terms of the Creative Commons Attribution License (CC-BY 4.0), which permits unrestricted use, distribution and reproduction in any medium, provided the original work is properly cited. |
Keywords: | breast cancer, optimization, medication adherence, acceptance and commitment therapy, text messaging, factorial trial |
Dates: |
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Institution: | The University of Leeds |
Academic Units: | The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Medicine (Leeds) > Leeds Institute of Health Sciences (Leeds) > Academic Unit of Primary Care (Leeds) |
Funding Information: | Funder Grant number NIHR National Inst Health Research NIHR300588 |
Depositing User: | Symplectic Publications |
Date Deposited: | 13 Jan 2025 13:34 |
Last Modified: | 06 Feb 2025 11:52 |
Status: | Published online |
Publisher: | Springer |
Identification Number: | 10.1093/abm/kaaf003 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:221639 |