“Deborah agreed to take part in a trial as she was keen to help other cancer patients in the future. "If taking part in a trial means others might be helped then I’m very happy with that."
A study to support women to take their hormone therapy following breast cancer (SWEET)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is looking at a support package to encourage women to take their hormone therapy after breast cancer treatment.
Please note, you can’t volunteer to join this study. The team at your local NHS centre will approach you if they are in the study and think you are suitable to join.
More about this trial
It is usual to have hormone therapy after treatment for breast cancer. Hormone therapy helps to reduce the chance of breast cancer coming back. You usually have it for several years. You take it every day as a tablet.
We know that some women don’t take this medication as prescribed. Or sometimes they stop taking it all together.
In this study, the team are developing and testing a support package. It is called HT&Me. It has been designed with help from healthcare professionals and women who have breast cancer. The team hope it will encourage and support women to take their hormone therapy as prescribed. This will reduce the risk of breast cancer coming back.
The support package includes an initial consultation with a study nurse and follow up calls. It also includes an online support tool. This is on the HT&Me website.
The aim of this study is to test the HT&Me support package with women who are taking hormone therapy. The team would like to find out:
- how helpful the support is
- what works well
- what could be improved
- how acceptable it is for women to use the support package
Please note there will be no benefit if you agree to join this study. The information the researchers gain may help people with breast cancer in the future.
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 the study if all of the following apply. You:
- are female
- have invasive breast cancer that is
oestrogen receptor positive
- have stage 1 to stage 3 breast cancer. This is breast cancer that hasn’t spread to other parts of the body.
- have breast cancer that has been treated with the aim to cure
- have had surgery to remove the cancer
- have completed chemotherapy if you had this
- have access to the internet and you have an email address
- are willing to use a support package via a website
- are at least 18 years old
As well as the above the following must also apply:
- to join sub study 1 you must have started tamoxifen or an
aromatase inhibitorwithin 3 months
- to join sub study 2 you must have started tamoxifen or aromatase inhibitor within 9 months to 3 years
Who can’t take part
You cannot join this study if any of these apply. You:
- are male
- have early stage invasive breast cancer that is oestrogen positive. Your doctor will know this.
- have cancer that has spread to other parts of the body
- are taking a
targeted cancer drugcalled abemaciclib or a similar drug. Your doctor will know this.
- have a problem with your memory that the study team think could affect you taking part in the study
- have had hormone treatment in the past. For example you had it to treat another breast cancer.
- can’t read and understand English
There are 2 sub studies. The team need 45 people to join each sub study.
You can’t volunteer to take part. The team will identify who is suitable at an
Sub Study 1
To begin with, you complete some questionnaires. These ask:
- your date of birth
- your ethnicity
- about your lifestyle
- about your experience and beliefs about taking hormone therapy
- about your experience of having breast cancer
You complete these questionnaires in your own time either online or on paper. If you choose to complete them on paper, the team provide you with a freepost envelope.
You then have an appointment with a study nurse. This can be face to face, over the telephone, or a video call. It takes about half an hour. The nurse will ask you about your experiences of hormone therapy so far. They also show you the HT&Me website and how it works. This website can be accessed by smartphone, tablet, or computer.
The team will record some consultations. This is so they can review how they went. The nurse will ask your permission to record them.
Around 3 to 4 weeks later you have a second appointment with the study nurse. It takes about half an hour. At this appointment, the nurse:
- checks how you are getting on with your hormone therapy and
- asks what you think about the HT&Me website
This consultation might be recorded. Every couple of weeks the team send you an email or text message to tell you about what is on the website.
About a month later, they send a couple of follow up questionnaires. You complete these either online or on a paper copy by post depending on your preference.
A member of the research team will ask if you would be happy to take part in an interview. This is to discuss what you think about the support package and your experience of taking part in the study.
Sub study 2
You don’t have to do anything other than agree for the study team to look at your medical records and what hormone treatment you have had. The team check your medical notes to get some details about you and your breast cancer. They send this to an organisation called NHS Digital and your GP. This is so they can add information about the prescriptions you have had since you were diagnosed with breast cancer. NHS Digital and your GP will then pass this information back to the research team for analysis.
You might have a few extra hospital visits if you join sub study 1 and have face to face consultations.
You don’t have any extra hospital visits if you are in sub study 2.
You might find some of the questions about your cancer upsetting. In the consultations and interview, you don’t have to talk about anything that you are not comfortable with. You can also take a break or stop at any point.
You might want to talk to someone after your consultation or interview, or at any time during the study. The team can signpost you to helpful organisations.
We have more information about hormone therapy for breast cancer.
How to join a clinical trial
Professor Linda Sharp
Breast Cancer Now
Independent Cancer Patients Voice
NIHR Programme Grants for Applied Research (PGfAR)
Newcastle upon Tyne Hospitals NHS Foundation Trust