The ROSETA Optimisation Trial – Investigating strategies to improve medication adherence in women with early-stage breast cancer

INTERVENTION: This study aims to recruit a total of 512 women with breast cancer from around 25 NHS sites in the UK. Potential participants will be screened according to pre‐defined criteria and approached during end of treatment summary meetings, appointments to discuss side effects and/or problems with medication taking, or by post/email. Potential participants will also be alerted to the trial via the Be Part of Research Volunteer Service (a register open to members of the public interested in research), cancer support groups, social media and charities. Interested patients will be encouraged to access the ROSETA website to read further information about the trial and complete a screening questionnaire. The CTRU will contact patients who self‐refer through the website to inform them whether or not they may be suitable to take part, and securely pass on the details of those suitable to the research team at their local NHS site. The local research team will confirm suitability to take part, take informed consent and collect data from the participant’s medical records. The participant will complete the baseline questionnaire. Following consent and baseline data collection, an automated system will be used to randomly allocate participants to one of 16 groups. A group can be a combination of interventions, one intervention or no interventions. All groups will receive the usual care provided by their hospital. Details of what women will receive when allocated to a group are as follows: Group 1: usual care, text reminders, information leaflet, ACT, website Group 2: usual care, text reminders, information leaflet, ACT Group 3: usual care, text reminders, information leaflet, website Group 4: usual care, text reminders, information leaflet Group 5: usual care, text reminders, ACT, websi CONDITION: Supporting adjuvant endocrine therapy (AET) adherence in breast cancer ; Cancer PRIMARY OUTCOME: To determine the most effective intervention package for supporting adjuvant endocrine therapy (AET) adherence by using the Domains of Subjective Extent of Nonadherence (DOSE‐Nonadherence) measure – collected at 12 months post‐randomisation SECONDARY OUTCOME: Secondary Outcomes (at 12 months post‐randomisation):; 1. Determine the most effective intervention package for:; 1.1. Supporting AET adherence and persistence measured using NHS prescribing and/or dispensing data; 1.2. Global quality of life (QoL) using EuroQol 5 Dimensions 5 Levels (EQ‐5D‐5L) and McGill Quality of Life‐Revised (MQoL‐R); 1.3. Self‐efficacy using Self‐Efficacy for Appropriate Medication Use Scale (SEAMS); 1.4. For supporting AET adherence, considering key restraints such as cost using DOSE‐Nonadherence; 2. Estimate the cost of developing and delivering each intervention component using NHS Reference Costs, Personal Social Services Research Unit (PSSRU) cost data and UK Cancer Costs questionnaire; ; Secondary Outcomes (at 4‐ and 8‐ months post‐randomisation):; 1. Estimate the main effects and interactions of the intervention components for: ; 1.1. Supporting AET adherence using DOSE‐Nonadherence; 1.2. Global quality of life using EuroQol 5 Dimensions 5 Levels (EQ‐5D‐5L) and McGill Quality of Life‐Revised (MQoL‐R); 1.3. Self‐efficacy using Self‐Efficacy for Appropriate Medication Use Scale (SEAMS); 2. Estimate the effect of the (at 4‐, 8‐ and 12‐months post randomisation):; 2.1. SMS component on habit formation using Self‐Report Behavioural Automaticity Inde X(SRBAI); 2.2. The information leaflet on beliefs about medication using Beliefs about Medicine Questionnaire‐Adjuvant Endocrine Therapy (BMQ‐AET); 2.3. ACT component on psychological flexibility and distress using Multidimensional Psychological Flexibility Inventory – Short version (MPFI) and Depression, Anxiety and Stress Scale‐21 (DASS‐21); 2.4. Website component on symptomatic quality of life using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire‐C30 (EORTC QLQ‐C30), European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire‐BR45 (EORTC QLQ‐BR45) and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire‐IL133 (EORTC QLQ‐IL133); ; SWAT; 1. Questionnaire response rate at one month follow‐up. ; 2. Proportion of participants in each SWAT group who submit the questionnaire within 6 days, 11 days of them being sent out.; 3. Number of days between the questionnaire being sent to participants and it being submitted by participants. ; 4. Proportion of non‐mandatory questionnaire items missing; 5. Proportion of non‐mandatory questionnaire measures with complete data; 6. Cost of SWAT intervention per participant retained at one‐month. INCLUSION CRITERIA: 1. Capacity to provide informed consent 2. Women with early stage (1‐3) breast cancer according to the Tumor, Node, Metastasis (TNM)/American Joint Committee on Cancer (AJCC) staging system Note: Women being treated for a second primary breast cancer or a breast cancer local recurrence are eligible for the trial, providing at least one of the cancers is being treated with AET, and they meet all eligibility criteria. Women with bilateral breast cancer are permitted, providing at least one breast is affected by hormone receptor‐positive disease 3. Aged > = 18 years old 4. Have sufficient proficiency in English to be able to adhere to all intervention components and data collection required 5. Treated with curative intent 6. Completed their hospital‐based treatment (e.g., surgery, radiotherapy and/or chemotherapy) for the current breast cancer within the last 12 months Note: Women are still eligible for the trial if they are being treated with ab