
“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is for women with primary breast cancer who have completed surgery and either radiotherapy or chemotherapy or both. They must have 7 or more hot flushes (flashes) or night sweats a week and rate these as problematic.
7 out of 10 women (70%) who have had treatment for breast cancer have hot flushes and night sweats. And these can have a negative impact on daily life and ability to sleep.
There are drug treatments that can help but these can have unpleasant side effects.
A number of research studies have shown that a talking therapy called can help reduce the impact of hot flushes and night sweats. It also improved people’s mood and quality of life. In the research the therapy was done by clinical
with groups of women. Only some of the women had breast cancer.
In this trial, breast care nurses are trained in CBT. The researchers want to find out if the nurses can deliver a similar reduction in the impact of hot flushes and night sweats for women who have had treatment for breast cancer.
The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
You may be able to join this trial if all of the following apply. You
You cannot join this trial if any of these apply. You
This is a randomised trial. The researchers would like between 120 to 160 women to take part.
Firstly the researchers will ask some questions about how often you have hot flushes and night sweats and how much they affect your daily life. This is to make sure you are able to take part in the trial.
If you are suitable, the researchers take your details. They will get in touch with you when they have enough women to form a therapy group at, or near, your local hospital.
Everyone taking is put into 1 of 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
CBT group
You have 6 therapy sessions, once a week at your local hospital or somewhere nearby. The session lasts about 90 minutes and is led by a breast care nurse following a CBT manual.
To check the quality of the sessions they are recorded by the trial team.
Some people in the CBT group will be asked to have a face to face interview with one of the trial team. They want to ask some questions about the CBT and whether there was anything not covered in the questionnaires used in the trial.
Usual NHS care
You don’t attend the therapy sessions. But at the end of the trial you are offered a booklet and CD that includes the same information people in the CBT group had. You can have a one to one meeting with a breast care nurse to go through the main parts of the booklet. The team also phone you on 2 occasions to see how you are getting on and ask about any problems you might be having with the CBT.
Questionnaires
Everyone taking part is asked to complete some questionnaires at:
These ask questions about your:
You are also be asked to keep a diary record of how many hot flushes you have over a number of days and how much these bother you.
If you are in the group having CBT you need to attend your therapy session once a week for 6 weeks.
If you are having usual NHS care and you accept the booklet and CD at the end of the trial, if you want, you can have one visit with a breast care nurse.
You are not expected to have any negative side effects from taking part in this trial.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Deborah Fenlon
Breast Cancer Now
Southampton Clinical Trials Unit
University of Southampton
Freephone 0808 800 4040
“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”