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

Tools

Smith, Samuel G. and Green, Sophie M.C. and McNaught, Emma and Graham, Christopher D. and Foy, Robbie and Ow, Pei Loo and French, David P. and Hall, Louise H. and Wilkes, Hollie and Taylor, Christopher and Ellison, Rachel and Raine, Erin and Walwyn, Rebecca and Howdon, Daniel and Clark, Jane and Rousseau, Nikki and Buxton, Jacqueline and Moore, Sally J.L. and Waller, Jo and Parbutt, Catherine and Velikova, Galina and Farrin, Amanda and Collinson, Michelle (2025) Supporting endocrine therapy adherence in women with breast cancer : findings from the ROSETA pilot fractional factorial randomized trial. Annals of Behavioural Medicine. ISSN 0883-6612 (In Press)

[thumbnail of Smith-etal-ABM-2025-Supporting-endocrine-therapy-adherence-in-women-with-breast-cancer] Text. Filename: Smith-etal-ABM-2025-Supporting-endocrine-therapy-adherence-in-women-with-breast-cancer.pdf
Accepted Author Manuscript
Restricted to Repository staff only until 1 January 2099.
Download (1MB) | Request a copy

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 multi-site individually randomized external pilot trial using a 24-1 fractional factorial design (ISRCTN10487576). Breast cancer survivors prescribed AET were recruited from five hospitals and randomized to one of eight conditions, each comprising a combination of four 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 pre-defined cut-offs 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 three 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.

ORCID iDs

Smith, Samuel G., Green, Sophie M.C., McNaught, Emma, Graham, Christopher D. ORCID logoORCID: https://orcid.org/0000-0001-8456-9154, Foy, Robbie, Ow, Pei Loo, French, David P., Hall, Louise H., Wilkes, Hollie, Taylor, Christopher, Ellison, Rachel, Raine, Erin, Walwyn, Rebecca, Howdon, Daniel, Clark, Jane, Rousseau, Nikki, Buxton, Jacqueline, Moore, Sally J.L., Waller, Jo, Parbutt, Catherine, Velikova, Galina, Farrin, Amanda and Collinson, Michelle;
CORE (COnnecting REpositories)