Refining and optimising a behavioural intervention to support endocrine therapy adherence (ROSETA) in UK women with breast cancer: protocol for a pilot fractional factorial trial
Samuel G Smith,
David P French,
Galina Velikova,
Amanda Farrin,
Robbie Foy,
Nikki Rousseau,
Daniel Howdon,
Jane Clark,
Michelle Collinson,
Christopher D Graham,
Rebecca Walwyn,
Emma McNaught,
Ellen Mason,
Sophie M C Green,
Rachel Ellison,
Louise H Hall,
Hollie Wilkes,
Erin Raine,
Jacqueline Buxton,
Sally J L Moore,
Catherine Parbutt
Affiliations
Samuel G Smith
Academic Unit of Primary Care, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK
David P French
School of Psychological Sciences, Division of Psychology and Mental Health, University of Manchester, Manchester, UK
Galina Velikova
Leeds Institute of Medical Research, University of Leeds, Leeds, UK
Amanda Farrin
Complex Interventions Division, Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK
Robbie Foy
Academic Unit of Primary Care, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK
Nikki Rousseau
Surgical, Diagnostic and Devices Division, Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK
Daniel Howdon
Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK
Jane Clark
Department of Clinical and Health Psychology, Leeds Teaching Hospitals NHS Trust, Leeds, UK
Michelle Collinson
Complex Interventions Division, Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK
Christopher D Graham
School of Psychology, Queens University Belfast, Belfast, UK
Rebecca Walwyn
Complex Interventions Division, Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK
Emma McNaught
Complex Interventions Division, Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK
Ellen Mason
Complex Interventions Division, Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK
Sophie M C Green
Academic Unit of Primary Care, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK
Rachel Ellison
Complex Interventions Division, Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK
Louise H Hall
Academic Unit of Primary Care, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK
Hollie Wilkes
Complex Interventions Division, Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK
Erin Raine
Academic Unit of Primary Care, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK
Jacqueline Buxton
Academic Unit of Primary Care, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK
Sally J L Moore
Academic Unit of Primary Care, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK
Catherine Parbutt
Medicines Management and Pharmacy Services, Leeds Teaching Hospitals NHS Trust, Leeds, UK
Introduction Women with breast cancer who do not adhere to adjuvant endocrine therapy (AET) have increased risks of mortality and recurrence. There are multiple barriers to AET adherence, including medication side-effects, beliefs about medication, memory and psychological distress. We developed four intervention components, each targeting a different barrier. This pilot trial is part of the preparation phase of the Multiphase Optimisation Strategy, and aims to establish key trial parameters, establish intervention component adherence, establish availability and feasibility of outcome and process data, estimate variability in planned outcome measures and estimate cost of developing and delivering each intervention component.Methods and analysis The four intervention components are as follows: short message service text reminders (target: memory); a written information leaflet (target: medication beliefs); a guided self-help Acceptance and Commitment Therapy programme (target: psychological flexibility to reduce distress) and a self-management website (target: side-effect management). To evaluate the feasibility of recruitment, acceptability of the intervention components and the availability of outcome data, we will conduct a multisite, exploratory pilot trial using a 24-1 fractional factorial design, with a nested process evaluation. We will randomise 80 women with early-stage breast cancer who have been prescribed AET to one of eight experimental conditions. This will determine the combination of intervention components they receive, ranging from zero to four, with all conditions receiving usual care. Key outcomes of interest include medication adherence and quality of life. Progression to the optimisation phase will be based on predefined criteria for consent rates, patient adherence to intervention components and availability of medication adherence data.Ethics and dissemination The study was reviewed by the Wales Research Authority Research Ethics Committee 3 (21/WA/0322). Written informed consent will be obtained from all patients before randomisation. The results of this trial will be disseminated in a peer-reviewed journal.Trial registration number ISRTCN10487576.
