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Randomized Controlled Trial
. 2025 Jan 4;59(1):kaaf003.
doi: 10.1093/abm/kaaf003.

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

Samuel G Smith  1 , Sophie M C Green  1 , Emma McNaught  2 , Christopher D Graham  3 , Robbie Foy  1 , Pei Loo Ow  2 , David P French  4 , Louise H Hall  1 , Hollie Wilkes  2 , Christopher Taylor Ba  2 , Rachel Ellison  2 , Erin Raine  1 , Rebecca Walwyn  2 , Daniel Howdon  1 , Jane Clark  5 , Nikki Rousseau  2 , Jacqueline Buxton Ba  6 , Sally J L Moore  6 , Jo Waller  7 , Catherine Parbutt  8 , Galina Velikova  9 , Amanda Farrin  2 , Michelle Collinson  2
Affiliations
Randomized Controlled Trial

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

Samuel G Smith et al. Ann Behav Med. .

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.

Keywords: acceptance and commitment therapy; breast cancer; factorial trial; medication adherence; optimization; text messaging.

Plain language summary

Most women with breast cancer are prescribed a medication called adjuvant endocrine therapy (AET) to reduce the chance of breast cancer returning. However, many women struggle to take (adhere to) AET for several reasons. We developed an intervention with 4 components to target key barriers to taking AET: text messages, information leaflet, guided self-help, and side effect self-management website. We conducted a small trial to answer key questions ahead of a larger trial. Women prescribed AET were recruited from 5 hospitals in the United Kingdom. They were randomly allocated to one of 8 groups made up of different combinations of the 4 intervention components. We set out criteria to help us decide whether to proceed to a larger trial. One hundred forty-one women were eligible to take part, of which 54 (38.3%) agreed to participate. At least half of the participants engaged with the minimum level of each intervention component. We could only get data for one of our 3 assessments of AET adherence. Most (86.8%) participants were satisfied with their trial experience. Overall, we met the criteria we set to proceed to a larger trial, but we will need to review how we measure medication adherence.

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Conflict of interest statement

S.G.S. declares consulting fees from Lily for participation in an advisory board. R.F. chairs the Implementation Strategy Group of the UK National Institute for Health and Care Excellence. M.C. declares being a Data Monitoring and Ethics Committee and Trial Steering Committee member of NIHR funded projects and being a member of NIHR grant funding panels. G.V. declares receiving honoraria from Pfizer, Novartis, Eisai, and Lilly, consultancy fees for advisory board membership from AstraZeneca, Roche, Novartis, Pfizer, Seagen, Eisai, Sanofi, and receipt of an institutional grant from Pfizer. All other authors declare no conflict of interest.

Figures

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Figure 1.
CONSORT flow.
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