A study looking at helping women stay on hormone therapy after breast cancer (SWEET)
Cancer type:
Status:
Phase:
This study is looking at a support package to help women to continue taking their 
after having breast surgery. The team hope that use of the support package will help women to keep taking their hormone therapy as recommended by their doctors, and improve their wellbeing ).
It is open to women who have (ER positive) breast cancer and have been prescribed:
- tamoxifen
- letrozole
- anastrozole
- exemestane
- any other
aromatase inhibitor
More about this trial
Following their initial treatment, doctors recommend that women with ER positive breast cancer have hormone therapy. Women are recommended to continue to take hormone therapy for at least 5 years or more. This is to reduce the risk of the cancer coming back.
We know that some women do not take their hormone therapy every day and others stop taking it before they should. This can increase the risk of the cancer coming back. In this study, the team have developed a support package which includes:
- 2 in person or online appointments with a trained study nurse
- a short animation video about hormone therapy
- access to an interactive website to encourage women to take their hormone therapy as prescribed
- regular email or text messages
The support package is called HT&Me.
The main aim of the study is to see whether the HT&Me support package can help women to take, and continue taking, their hormone therapy, and whether it improves their quality of life.
Who can enter
The following bullet points are a summary of the entry conditions for this study. Talk to your doctor at the hospital 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 study if all of the following apply. You:
- are female
- have breast cancer that is oestrogen positive (ER positive) that is an early cancer (stage 1 or stage 2) or has spread only to the nearby
lymph nodes , skin on the breast or chest wall (stage 3) - have had treatment with the aim to cure
- have completed your surgery. If you had chemotherapy after your surgery this should be completed.
- have been prescribed your first treatment of hormone therapy after your main treatment. And have been prescribed this hormone therapy within the past 14 weeks.
- have access to the internet and an email address
- are willing to use the support package on the internet
- are able to read and understand English
- are at least 18 years old
If all the above apply, you may also be able to take part if you:
- are having, or are due to have, radiotherapy
- are having, or are due to have, a treatment that targets
HER2 receptors such as trastuzumab - are having, or due to have, another
targeted treatment such as abemaciclib - are having medication to stop your ovaries working
- had hormone treatment before your surgery
- had a previous
primary breast cancer and did not have hormone treatment after your treatment
Who can’t take part
You cannot join this study if any of these apply. You:
- have cancer spread to another part of the body (stage 4)
- have had hormone therapy after your main treatment for a previous breast cancer
- have a problem with thinking, learning, remembering and making decisions that could affect you taking part
Trial design
The team need 1,460 women to take part. This is a randomised study. A computer puts you into a group. You cannot choose which group you are in. There are 2 groups in this study:
- 730 women will have the HT&Me support package as well NHS routine care
- 730 women will have NHS routine care
HT&Me support package
The HT&Me support package includes a website that you can interact with. It also involves the following. You will have a meeting with one of the study nurses. This will take about 30 minutes. The meeting can be either:
- in person at your local hospital
- a video call or
- phone call if needed
The study nurse will:
- discuss your hormone therapy
- answer any questions you have
- introduce you to the HT&Me website
On the website you have access to:
- short videos about hormone therapy
- information about hormone therapy
- hints and tips to help support you taking your hormone therapy
- interactive tools such as setting reminders to take your hormone therapy or to order a repeat prescription, and diary to record side effects
- tips about managing side effects based on scientific evidence and experiences of other women like you
- where more information and support is available if you need it
After 12 weeks the study nurse will contact you again. This is to see how you are getting on with your hormone therapy and also how you are getting on using the website.
They might ask if they can audio record these two appointments. This is so the team can check what information you have had and to make sure these appointments are going as planned. You don’t have to agree to this.
During the study, once a month, the team will send you an email or text message to remind you:
- about the importance of taking your hormone therapy
- that the website may be a useful resource for you
You also receive the routine NHS care. This includes your follow up appointments at the breast clinic.
NHS routine care
Your doctor or nurse will tell you how and when to take your hormone therapy. You will continue to have follow up appointments in the breast clinic.
Both groups
The team will contact you at:
- 6 months
- 12 months
- 18 months
They will ask:
- how you are getting on with your hormone therapy
- how often you are taking your hormone therapy
- about your wellbeing (quality of life)
- about your use of other health services such as your GP
Interview – both groups
The team might ask if you are willing to take part in an interview. This will be either on the phone or as a video call. They want to find out your views on taking part in the study. You don’t have to agree to the interview if you don’t want. You can still take part in the main study.
Hospital visits
There are no extra visits to clinics at the hospital if you take part in the study. If you are allocated to having HT&Me, you might be asked to come back to the hospital for the first appointment with the study nurse.
Side effects
The study team do not expect there to be any risk from taking part in the study. But they understand that talking about your cancer could be upsetting. If you want to talk to someone about your cancer, they can give you information about organisations that can help you.
We have more information about:
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 Linda Sharp
Professor Eila Watson
Supported by
NIHR Programme Grants for Applied Research (PGfAR)
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle University
Warwick Clinical Trials Unit
Breast Cancer Now
University College London
Other information
The study team have a public website at https://www.sweetstudy.co.uk/.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
