The ROSETA Optimisation Trial – Investigating strategies to improve medication adherence in women with early-stage breast cancer
| ISRCTN | ISRCTN17334319 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17334319 |
| IRAS number | 328413 |
| Secondary identifying numbers | CPMS 58021, IRAS 328413 |
- Submission date
- 29/01/2024
- Registration date
- 02/02/2024
- Last edited
- 02/09/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Background and study aims
The ROSETA Optimisation trial is testing how well four ways (called interventions) support women with breast cancer in taking hormone therapy (e.g., Tamoxifen, Raloxifene, Anastrozole, Letrozole, Exemestane). The study will test what, if any, is the best combination of the interventions. The interventions being tested comprise SMS text reminders to support taking medication, a leaflet providing information about the medication, a website to provide useful resources for managing the side effects of the medication, and a skills programme known as Acceptance and Commitment Therapy (ACT) which encourages approaching experiences with openness and awareness, and supports you to engage with your values. This is led by a therapist and involves learning and practising skills at home.
Who can participate?
Women aged 18 years old and over who have been diagnosed with breast cancer and prescribed medication to reduce the risk of the cancer returning
What does the study involve?
The study team will:
• Confirm participants' eligibility and ask if they consent to take part.
• Ask them to complete a total of 4 questionnaires over 12 months.
• Ask them if they are willing to be interviewed after around 4 and 12 months, to discuss their experiences of taking part. The interviews are optional, so they can take part in ROSETA without being interviewed.
Participants will be randomly allocated either to one or more of the interventions in addition to your usual care, or to your usual care alone. If they are randomly allocated to the ACT sessions, you will attend a total of 5 remote sessions and will be asked to complete home practice tasks.
What are the possible benefits and risks of participating?
BENEFITS: Although it is not known which intervention, if any, helps women with breast cancer, participants might personally find them useful. They will also be contributing to important research that may benefit women with breast cancer in the future. They may also enjoy learning more about health research.
RISKS: No risks in taking part are expected. Agreeing to take part in this study will mean giving up some time to complete questionnaires. Some questionnaires ask about how they are feeling, and this may upset some people. Your researcher will provide details of organisations that can be contacted if the research is upsetting in any way.
Where is the study run from?
The trial is centrally coordinated by the Leeds Clinical Trials Research Unit (CTRU) based at the University of Leeds
When is the study starting and how long is it expected to run for?
January 2023 to November 2026
Who is funding the study?
The study is funded by the National Institute of Health Research (NIHR) (https://fundingawards.nihr.ac.uk/award/NIHR300588)
Who is the main contact?
ROSETA@leeds.ac.uk
https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-supporting-people-with-their-hormone-therapy-for-breast-cancer-roseta
Contact information
Prof Sam Smith
Scientific
Scientific
Leeds Institute of Health Sciences, University of Leeds
Leeds
LS2 9JT
United Kingdom
 ORCID ID |
0000-0003-1983-4470 |
|---|---|
| Phone | +44 (0)113 343 0892 |
| S.Smith1@leeds.ac.uk |
Dr ROSETA Optimisation Trial Team
Public
Public
Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds
Leeds
LS2 9JT
United Kingdom
| Phone | None provided |
|---|---|
| ROSETA@leeds.ac.uk |
Study information
| Study design | Randomized controlled 2⁴ factorial optimisation trial with an embedded Study Within a Trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home, Internet/virtual, Medical and other records, Telephone |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Refining and Optimising a behavioural intervention to Support Endocrine Therapy Adherence: The ROSETA Optimisation Trial |
| Study acronym | The ROSETA Optimisation Trial |
| Study objectives | To determine the most effective intervention package for supporting adjuvant endocrine therapy (AET) adherence at 12 months post-randomisation. This trial will also have an embedded Study Within a Trial (SWAT), a self-contained research study that has been embedded within the host trial to evaluate ways of delivering follow-up trial processes. The overall aim of the SWAT is to understand the impact of SMS pre-notification and reminder messages in the context of clinical trials using online data capture for patient-reported questionnaires. |
| Ethics approval(s) |
Approved 25/01/2024, Yorkshire & The Humber - South Yorkshire Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, United Kingdom; +44 (0)207 104 8021; southyorks.rec@hra.nhs.uk), ref: 23/YH/0250 |
| Health condition(s) or problem(s) studied | Supporting adjuvant endocrine therapy (AET) adherence in 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, website Group 6: usual care, text reminders, ACT Group 7: usual care, text reminders, website Group 8: usual care, text reminders Group 9: usual care, information leaflet, ACT, website Group 10: usual care, information leaflet, ACT Group 11: usual care, information leaflet, website Group 12: usual care, information leaflet Group 13: usual care, ACT, website Group 14: usual care, ACT Group 15: usual care, website Group 16: usual care The four intervention components are: SMS text reminders: The content of the SMS reminders has been co-developed with experts in behaviour change and/or medication adherence, and women who have experienced breast cancer. Over 4 months participants randomised to a group containing this intervention will receive 43 SMS messages. These include 3 opening messages, 36 messages aiming to make medication taking more habitual, a closing message, and 3 messages informing participants they can stop the SMS messages by emailing the trial email address at any time (one per month). The SMS messages are sent by the CTRU and information about the delivery of the SMS messages will be routinely collected. Information leaflet; Participants randomised to a group containing this intervention will receive a 6-page patient information leaflet at 1 week post-randomisation. This will be sent to the participant by the local research team. The leaflet aims to target specific adjuvant hormone therapy medication beliefs. The content of this leaflet will include explanations of how adjuvant endocrine therapy (AET) works, supplemented by diagrams, information about the benefits and side effects of AET and answers to common concerns. The leaflet will also indicate that it has been codesigned by researchers and breast cancer survivors, and will include quotes from breast cancer survivors. They can then read this information leaflet as they wish. Participants will self-report whether or not they have received and read the information leaflet in the follow-up questionnaires. A website: The website will contain sections on managing side effects, patient stories (including videos) and signposting for further information/places of support. Participants randomised to a group containing this intervention will receive the website address and their unique login details at 1 week post-randomisation. The details will be sent to the participant by the local research team. Data will be collected about each participant's receipt of website details and their website use, including pages visited, whether videos were watched and the percentage of the video viewed on a per participant level. The data collected on a participant’s website registration and usage is collected by google analytics and will be obtained and summarised by the trial team at the CTRU. Only the University of Leeds will have access to the tracking data. Acceptance and Commitment Therapy (ACT): The ACT component is a guided self-help program consisting of four modules with home practice tasks. Participants randomised to a group containing this intervention will take part in five remote sessions with a therapist – one introductory session plus four modules, each corresponding to a different ACT-based skill: Mindfulness and unhooking; Following your values; Taking an observer perspective; Recap, reflection, and staying committed. Each module consists of a participant manual containing information about the relevant ACT skill, alongside home practice exercises to complete. All sessions will take place via videoconferencing or telephone, and each session will last 25 minutes. The first session will take place within 6 weeks of randomisation, and the remaining four sessions will occur approximately every two weeks thereafter. It is recommended that all five ACT sessions are delivered within 3 months of the first session. Within these support sessions, the therapist and the patient will discuss the module completed over the past week, their experiences of the home practice exercises, and can discuss and problem solve any difficulties that arose. Session attendance and engagement with home practice tasks will be monitored. The ACT sessions will be audio-recorded, if the participant gives consent, for the purpose of monitoring the therapist's delivery of ACT and to ensure the trial is being conducted properly. Recordings will be securely stored at the site and at the University of Leeds with access restricted to the trial team and those involved in monitoring therapist delivery of ACT. Suitably qualified therapists will be identified and will undergo a training programme in the ACT intervention prior to patient recruitment. This will be delivered by the central ACT intervention lead or delegate, who has expertise in ACT applied to chronic disease. Training will take place over 2-3 half days and will be delivered remotely via videoconferencing. Training will include general teaching about ACT and practice of intervention-specific therapy methods. Therapists will be trained in groups where feasible. Therapists delivering the intervention will be offered fortnightly group supervision (60 minutes), for the duration of the intervention by phone or video call, with the central ACT intervention lead or delegate. The therapist can also access local clinical supervision if they wish, as part of their standard clinical practice. To help further understand the interventions and how they worked in practice, researchers will interview a sample of participants and therapists, with their consent. This is called a process evaluation. The interviews will take place remotely via videoconferencing software or phone and will last no longer than 60 minutes. Interviews will be audio recorded. Participants will be invited to two interviews: one at 4-5 months post-randomisation and one at 12-13 months post-randomisation. Therapists will be invited to one interview one month before the end of the intervention delivery period. Participants will complete further questionnaires at 4, 8, and 12-months after randomisation, and receive a maximum of 4 reminders to complete by text, email and/or phone. They will be completed online via REDCap, a secure web application created by Vanderbilt University, or over the phone with the local research team. The CTRU manage the follow-up questionnaire process and the REDCap database. The trial includes an embedded Study Within A Trial (SWAT) where the participant is randomised to receive a pre-notification (24 hours before questionnaire is sent) at 4- months post-randomisation. Participants will retain their allocation to SMS pre-notification or no pre-notification at 8 and 12-months. Participants who have not returned the questionnaire after 6 days will be randomised again to receive either standard SMS reminder or non-standard reminder. The local research team will also collect additional data from the participant’s medical records at the end of the trial. The CTRU will collect participant prescribing and/or dispensing data at 12-months post-randomisation via central sources of healthcare data such as NHS Digital (a standard NHS patient registry). The CTRU will also explore the possibility of using central sources of healthcare data such as NHS Digital to conduct longer-term follow-up (i.e. post 12-months randomisation) of those participants recruited early to the trial. |
| Intervention type | Behavioural |
| Primary outcome measure | 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 measures | 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 Index (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. |
| Overall study start date | 01/01/2023 |
| Completion date | 30/11/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | Planned Sample Size: 512; UK Sample Size: 512 |
| Key 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 abemaciclib or monoclonal antibody-based therapy such as trastuzumab, kadcyla, pertuzumab, and phesgo; these medications do not have to be completed within the 12 months stipulated within this criterion. 7. Currently prescribed oral AET (tamoxifen, raloxifene, anastrozole, letrozole, exemestane) 8. Access to a mobile phone to receive SMS messages* 9. Access to a computer or smart device that can access the internet* *Source data for these items will be either partially or completely patient self-report. |
| Key exclusion criteria | 1. Stopped taking AET if it is clinically contraindicated according to clinical recommendation 2. Involved in a similar research trial where medication adherence is a primary outcome*,** 3. Currently attending psychotherapy/psycho-oncology/psychology/counselling services, for any clinical reason* 4. Need for treatment for a severe mental health disorder or crisis, which is likely to interfere with participation (e.g., active psychosis, bipolar disorder, significant issues with addiction or self-harm or expressing active suicidal ideation with active plans and intent*) 5. Auditory problems that would prevent the patient from participating in a telephone or video call, or hearing audio clips* 6. Taken part in the ROSETA Pilot trial. *Source data for these items will be either partially or completely patient self-report. **Consented to and the trial is still being delivered. Participation in another trial will not necessarily exclude a patient from participation. CTRU should be notified of any potential conflicting trials to facilitate a review of the feasibility of co-enrolment by the CI and Trial Management Group (TMG). The review will consider the methodological impact and participant burden. |
| Date of first enrolment | 30/04/2024 |
| Date of final enrolment | 31/03/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Leeds Teaching Hospitals NHS Trust - Lead centre
St. James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom
Beckett Street
Leeds
LS9 7TF
United Kingdom
Pinderfields Hospital
Aberford Road
Wakefield
WF1 4DG
United Kingdom
Wakefield
WF1 4DG
United Kingdom
Manchester University NHS Foundation Trust
Cobbett House
Oxford Road
Manchester
M13 9WL
United Kingdom
Oxford Road
Manchester
M13 9WL
United Kingdom
Northwick Park Hospital
Watford Road
Harrow
HA1 3UJ
United Kingdom
Harrow
HA1 3UJ
United Kingdom
Croydon University Hospital
London Road
Croydon
CR7 7YE
United Kingdom
Croydon
CR7 7YE
United Kingdom
Chesterfield Royal Hospital NHS Foundation Trust
Chesterfield Road
Calow
Chesterfield
S44 5BL
United Kingdom
Calow
Chesterfield
S44 5BL
United Kingdom
Mid and South Essex NHS Foundation Trust
Prittlewell Chase
Westcliff-on-sea
SS0 0RY
United Kingdom
Westcliff-on-sea
SS0 0RY
United Kingdom
Watford General Hospital
60 Vicarage Road
Watford
WD18 0HB
United Kingdom
Watford
WD18 0HB
United Kingdom
University Hospital Lewisham
Lewisham High Street
London
SE13 6LH
United Kingdom
London
SE13 6LH
United Kingdom
Whiston Hospital
Warrington Road
Prescot
L35 5DR
United Kingdom
Prescot
L35 5DR
United Kingdom
East Surrey Hospital
Canada Avenue
Redhill
RH1 5RH
United Kingdom
Redhill
RH1 5RH
United Kingdom
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
Bradford
BD9 6RJ
United Kingdom
Bolton Royal Hospital
Minerva Road
Farnworth
Bolton
BL4 0JR
United Kingdom
Farnworth
Bolton
BL4 0JR
United Kingdom
Hull Royal Infirmary
Anlaby Road
Hull
HU3 2JZ
United Kingdom
Hull
HU3 2JZ
United Kingdom
St Marys Hospital
Floyd Drive
Warrington
WA2 8DB
United Kingdom
Warrington
WA2 8DB
United Kingdom
York Hospital
Wigginton Road
York
YO31 8HE
United Kingdom
York
YO31 8HE
United Kingdom
The Princess Alexandra Hospital NHS Trust
Hamstel Road
Harlow
CM20 1QX
United Kingdom
Harlow
CM20 1QX
United Kingdom
Queen Elizabeth Hospital
Edgbaston
Birmingham
B15 2TH
United Kingdom
Birmingham
B15 2TH
United Kingdom
Sponsor information
University of Leeds
Hospital/treatment centre
Hospital/treatment centre
Woodhouse Lane
Leeds, West Yorkshire
LS2 9JT
England
United Kingdom
| Phone | +44 (0)113 343 7587 |
|---|---|
| governance-ethics@leeds.ac.uk | |
| Website | https://www.leeds.ac.uk/ |
"ROR" |
https://ror.org/024mrxd33 |
Funders
Funder type
Government
National Institute for Health and Care Research
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/11/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | De-identified individual participant data datasets generated and/or analysed during the current study will be available upon request from the Clinical Trials Research Unit, University of Leeds (contact CTRU-DataAccess@leeds.ac.uk in the first instance). Data will be made available at the end of the trial, i.e. usually when all primary and secondary endpoints have been met and all key analyses are complete. Data will remain available from then on for as long as CTRU retains the data. CTRU makes data available by a 'controlled access' approach. Data will only be released for legitimate secondary research purposes, where the Chief Investigator, Sponsor and CTRU agree that the proposed use has scientific value and will be carried out to a high standard (in terms of scientific rigour and information governance and security) and that there are resources available to satisfy the request. Data will only be released in line with participants' consent, all applicable laws relating to data protection and confidentiality, and any contractual obligations to which the CTRU is subject. No individual participant data will be released before an appropriate agreement is in place setting out the conditions of release. The agreement will govern data retention, usually stipulating that data recipients must delete their copy of the released data at the end of the planned project. The CTRU encourages a collaborative approach to data sharing and believes it is best practice for researchers who generated datasets to be involved in subsequent uses of those datasets. Recipients of trial data for secondary research will also receive data dictionaries, copies of key trial documents and any other information required to understand and reuse the released datasets. The conditions of release for aggregate data may differ from those applying to individual participant data. Requests for aggregate data should also be sent to the above email address to discuss and agree on suitable requirements for release. |
Editorial Notes
02/09/2025: The date of final enrolment was changed from 30/09/2025 to 31/03/2026.
06/03/2025: The following changes were made:
1. The recruitment end date was changed from 31/03/2025 to 30/09/2025.
2. The study website was added.
13/06/2024: Cancer Research UK link added to plain English summary field.
30/04/2024: The recruitment start date was changed from 31/03/2024 to 30/04/2024.
05/03/2024: The recruitment start date was changed from 29/02/2024 to 31/03/2024.
07/02/2024: Ethics approval details added.
29/01/2024: Study's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
