Supporting endocrine therapy adherence in women with breast cancer

Findings from the Roseta pilot fractional factorial randomized trial

Datos Bibliográficos

ID7146771
AutoresSamuel G Smith (0000-0003-1983-4470, University of Leeds), Sophie M C Green (0000-0002-2622-5377, University of Leeds), Emma McNaught (University of Leeds), Christopher D Graham (0000-0001-8456-9154, University of Strathclyde), Robbie Foy (0000-0003-0605-7713, University of Leeds), Pei Loo Ow (0000-0001-6025-6372, University of Leeds), David P French (0000-0002-7663-7804, University of Manchester), Louise H Hall (0000-0001-9032-4540, University of Leeds), Hollie Wilkes (University of Leeds), Ba Christopher Taylor (0009-0009-8220-4923, University of Leeds), Christopher Taylor Ba (University of Leeds), Rachel Ellison (0000-0001-9251-492X, University of Leeds), Erin Raine (0009-0006-4249-7459, University of Leeds), Rebecca Walwyn (0000-0001-9120-1438, University of Leeds), Daniel Howdon (0000-0001-8052-2893, University of Leeds), Jane Clark (0000-0001-9396-2193, Leeds Teaching Hospitals NHS Trust), Nikki Rousseau (0000-0001-8826-3515, University of Leeds), BA Jacqueline Buxton (Independent , Leeds, LS2 9NL), Jacqueline Buxton Ba (Oldham Council), Sally J L Moore (Independent , Leeds, LS2 9NL), Jo Waller (0000-0003-4025-9132, Queen Mary University of London), Catherine Parbutt (0009-0008-4047-0345, Medicines Management and Pharmacy Services, Leeds Teaching Hospitals NHS Trust , Leeds, LS9 7TF), Galina Velikova (0000-0003-1899-5942, Leeds Institute for Medical Research, University of Leeds , Leeds, LS9 7TF), Amanda Farrin (0000-0002-2876-0584, University of Leeds), Michelle Collinson (0000-0003-3568-6455, University of Leeds)
Año2025
Volumen59
Número1
Fecha de publicación2025-01-04
Peer ReviewedSí
Open AccessSí
TipoARTICLE
RevistaAnnals of Behavioral Medicine (JOURNAL)
Identificadores de la revistaISSN: 0883-6612 • E-ISSN: 1532-4796
EditorialOxford University Press (PUBLISHER • GB)
DOI10.1093/abm/kaaf003
PMID39887069
OpenAlexW4407050312
IdiomaEN
Referencias citadas63

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.

Breast cancer · Cancer · Health psychology · Physical therapy · Psychotherapist · Public health · Randomized controlled trial · Cancer survivorship and care · Clinical Psychology · Internal Medicine · Medication Adherence and Compliance · Medicine · Mobile Health and mHealth Applications · Nursing · Oncology · Psychology