A new clinical trial funded by Breast Cancer Now will investigate the best way to deliver cognitive behavioural therapy (CBT) to reduce the impact of two major side-effects for women undergoing breast cancer treatment.

Scientists will now investigate whether CBT – already proven to reduce hot flushes and night sweats – could be delivered effectively by breast cancer nurses, which would significantly improve access to this form of ‘talking therapy’ for breast cancer patients.

Hot flushes and night sweats are common side-effects of current breast cancer treatments such as chemotherapy and anti-hormone drugs. Experienced by up to 70% of women after breast cancer treatment, these menopausal symptoms can have a huge impact on their daily lives, often affecting employment, personal relationships and general quality of life, and sometimes leading to women not completing the full course of their treatment.

Hormone replacement therapy (HRT) – which is normally offered to women experiencing hot flushes as part of the menopause – unfortunately cannot be used by women with breast cancer as it can increase the risk of their disease returning. In addition, these side-effects can often be more extreme and longer-lasting in women who have had breast cancer than those experienced during natural menopause.

It is therefore essential that scientists and clinicians find ways to help women undergoing breast cancer treatment reduce the impact of these side-effects, to give them the best possible quality of life and help them to continue their treatment to reduce the risk of breast cancer returning.

On the effects of hot flushes, one participant of the MENOS 4 trial – a teacher, aged 52 – said:

“I had never expected hot flushes to be quite so awful. Some nights I just do not sleep as the hot sweats keep me awake and then I have to work the next day as though everything’s ok and it’s not. This research offers some hope for women like me who just want to find ways to manage these awful symptoms.”

Researchers have already shown that CBT – a type of ‘talking therapy’ – can help to reduce the impact that hot flushes and night sweats have on women undergoing breast cancer treatment, allowing them to regain a sense of control over these symptoms.

Although CBT is known to be effective, it is not currently offered routinely within the NHS for women with breast cancer. At present CBT can only be given to groups by trained clinical psychologists and there is nothing currently considered a universal gold standard of care in breast cancer treatment, meaning support to help patients manage these difficult symptoms varies across the country.

Professor Deborah Fenlon, currently based at Swansea University, has now been awarded a grant of over £300,000 by Breast Cancer Now to lead a three-year clinical trial (MENOS-4) at the Southampton Clinical Trials Unit, University of Southampton, to investigate whether the same CBT could be delivered effectively by breast cancer nurses. If so, this could significantly improve access to CBT as most women will see a breast cancer nurse during their treatment.

The study will involve up to 160 women undergoing breast cancer treatment who are experiencing severe and frequent hot flushes or night sweats, from six hospitals across England – Queen Alexandra Hospital (Portsmouth), Luton and Dunstable University Hospital, Yeovil District Hospital, York Teaching Hospital, Walsall Manor Hospital and Royal Glamorgan Hospital in Wales

Half of the women will receive group CBT from a breast cancer nurse (who has been specially trained by clinical psychologists to deliver the intervention), involving six weekly sessions lasting 90 minutes each, while the other half will receive whatever support they would normally receive.

The researchers will evaluate the impact of CBT on the women’s hot flushes and night sweats after 26 weeks. In addition, group CBT sessions will be recorded and analysed by independent psychologists, to assess its effectiveness when delivered by breast cancer nurses.

A process evaluation will also be conducted to explore the ways in which breast care nurses were able to implement the group therapy, so that, if it is successful, a blueprint could be created to show how this service might be organised locally.

Professor Deborah Fenlon, Nurse Researcher at Swansea University said:

“Hot flushes and night sweats can have a major impact on women’s lives: affecting their work, social life and disrupting their sleep. There are very few effective measures to help support women with this problem, particularly after breast cancer and proven interventions are not widely available. With this study we hope to show how an effective intervention can be offered more widely.”

Baroness Delyth Morgan, Chief Executive at Breast Cancer Now, said:

“Professor Fenlon’s research could pave the way for much wider access to CBT to help reduce the impact of hot flushes and night sweats on the lives of women with breast cancer.

“We know that CBT is a valuable, cost-effective way to help alleviate two particularly debilitating side-effects of breast cancer treatment, which could significantly improve the quality of life for many women, at this already difficult time.

“We need to continue to move towards more tailored and specialised treatments to better support and meet the needs of women living with and beyond breast cancer. We hope this trial will be an important first step to improving access to CBT for breast cancer patients and we look forward to the results.”

Any women being treated at any of the centres taking part in the trial who are experiencing troublesome hot flushes as a side-effect of treatment are encouraged to ask their breast care nurse about the study, which is currently recruiting participants.

Breast Cancer Now is grateful to Walk the Walk for their generous support of Breast Cancer Now’s Research Innovation Unit, which made this research possible.