A study looking at supporting people with their hormone therapy for breast cancer (ROSETA)
Cancer type:
Status:
Phase:
This study is looking at ways to support people to take their daily hormone therapy.
It is for people with early stage breast cancer who have finished their treatment to try and get rid of the cancer completely.
More about this trial
Hormone treatment for breast cancer is a 
to try and prevent the cancer coming back.
You take hormone treatment daily, often for a number of years. Some people with breast cancer struggle to take their medicines regularly and may stop.
Researchers are interested in supporting people with taking their medicines. There are several ways of doing this. But they don’t know which is best. Or, if any are better than the usual care people have for breast cancer. They are doing this study to try and find out.
They are looking at 4 different types of support:
- SMS text reminders
- a leaflet with information about the medicine
- a website with resources for managing side effects of medicines
- a skills programme called Acceptance and Commitment Therapy (ACT). You work with a therapist and it involves practicing skills at home.
The study team are looking at these types of support both alone and in combination.
The main aims of the study are to:
- find out the best way of helping people to continue to take their hormone therapy
- learn more about the
quality of life of people taking part
Who can enter
The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this trial if you have:
- early stage breast cancer. This means that the cancer has not spread further than to the lymph nodes close to the breast, the skin of the breast or to the chest wall. This is stage 1,2 or 3 breast cancer, or
- you might be able to take part if you have a second
primary breast cancer or your cancer has come back in the same place or very close to where it started (local recurrence), or - you might be able to take part if you have breast cancer in both breasts, if one of the cancers is
hormone receptor positive
Your doctor will know more.
All of the following must also apply. You:
- have had treatment to try and get rid of the cancer completely
- speak and understand English well enough to take part
- have finished your hospital based cancer treatment, including surgery, radiotherapy or
chemotherapy for your current breast cancer in the last 12 months. You might still be able to take part if you are still taking abemaciclib or you are having treatment with a monoclonal antibody . Your doctor will know this. - have been prescribed hormone therapy
- have access to a mobile phone to get text messages
- have access to a computer, phone or tablet which has the internet
- are aged 18 or over
Who can’t take part
You cannot join this study if any of these apply. You:
- have stopped taking hormone therapy
- are taking part in another study looking at how people take their medicines
- have a severe mental health problem which means it could be difficult for you to take part
- have hearing problems which means you would find it hard to have a phone call, video call or hear audio clips
- have taken part in the ROSETA
pilot study
Trial design
The researchers need around 500 people to take part from the UK.
It is a randomised trial. You are put into a group by a computer. Neither you nor your doctor will be able to decide which group you are in. There are 16 different groups. We haven’t listed them all here.
In summary you have either:
- one or more of the 4 types of study support as well as your usual care or
- your usual care alone
Usual care
Your treatment team can explain exactly what your usual care is. This might include having an end of treatment meeting with a breast care nurse. You might work together to fill in a questionnaire about what’s important to you at that time. And the nurse can give you details about local support and information services.
SMS text message reminders
You get a total of around 40 SMS messages over around 4 months. You choose if you’d like to get them in the morning, afternoon, or evening. They are a reminder to take your medication.
Information leaflet
The researchers send the medication information leaflet by email. You get it around 1 week after joining the study.
Side effects website
You get access to the website around 1 week after joining the study. You have access for around 12 months and can view it anytime. It gives you information about common side effects of your medication.
Acceptance and commitment therapy (ACT)
ACT is a type of specialist one-to-one talking therapy. It involves putting what is most important to you at the centre of your therapy, to try and improve your quality of life.
You have 5 remote support sessions with a therapist over around 4 months. Each session takes around 25 minutes. This is either over the phone or video call.
You have 4 module booklets to fill in at home. And you have an audio file to listen to for each module. The audio files have exercises and examples for each booklet. For example, one audio file helps with mindfulness practice as a way of being more aware of the world around you. Each module should take you no longer than 90 minutes to complete.
You don’t have to fill these in or listen to them to take part in the study. But the researchers think that this will help with getting the most out of your therapy.
The researchers would like to voice record your sessions. It’s optional so you can say no and still have ACT. It is to see if the one-to-one sessions were given by the therapist as agreed. The recording will not be heard by anyone other than the study team.
Questionnaires
You fill in questionnaires online about your health and wellbeing before you start the study. And then after at:
- 4 months
- 8 months
- 12 months
You should be able to complete the questionnaires in 45 minutes or less.
The researchers use the results of the questionnaires to see any changes throughout the study.
Questionnaire reminders
Everyone gets a message to remind them to fill in their questionnaires.
This can be by:
- phone
- text message
You might also get a message saying that your questionnaires are due to be sent to you soon.
There are several possible ways to get your reminder. Not everyone has the same reminder messages. This is decided by a computer. This is because the researchers are interested in finding out how best to remind people to fill in their questionnaires.
Interviews
The researchers would like to interview some people taking part. This is to find out more about their experience of taking part in the study.
The interviews are at around 4 months and 12 months after joining. The researchers can give you more information about this if you’re interested.
This part of the study is optional. You can say no to being interviewed and still take part in the study.
End of study
The researchers look at your NHS records after around a year. This is to see how you are getting on with taking your hormone therapy.
The study ends after a year.
Hospital visits
There are no extra hospital visits as part of this study.
Side effects
Some questionnaires ask about how you are feeling. This may upset some people. The study team gives you details of organisations that you can contact if the research upsets you in any way.
Location
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Professor Samuel Smith
Supported by
National Institute for Health and Care Research
University of Leeds
Clinical Trials Research Unit (CTRU) Leeds
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
