Menopausal symptoms—hot flushes and night sweats—experienced by women with breast cancer can be reduced through group cognitive behavioral therapy (CBT) delivered by breast care nurses, a new clinical trial involving the Southampton Clinical Trials Unit has revealed.
Up to 85% of women with breast cancer suffer from hot flushes and night sweats due to chemotherapy and hormone therapy treatments. These side effects are often more extreme and can last longer for women with breast cancer than for women who experience them due to natural menopause. Hormone replacement therapy (HRT) may be offered to relieve menopausal symptoms, but is not usually recommended for women with breast cancer because it may increase their risk of the disease returning, therefore safe and effective alternatives to reduce side effects and ensure quality of life are urgently needed.
Researchers funded by Breast Cancer Now have found that women with breast cancer, who received six weeks of group CBT from a breast care nurse, reported that their menopausal symptoms became significantly less distressing and less problematic. Their frequency also reduced by over a quarter (28%). This more than doubles the reduction of symptoms reported by women receiving standard care, and often ad hoc advice (11%). Furthermore, for the women who received CBT from a nurse, these life-changing benefits lasted several months.
For many women with breast cancer, menopausal side effects can have a devastating impact on both their quality of life and mental health; consequently, some women stop treatment that could help prevent their breast cancer returning. However, in the study women reported that after receiving CBT from a nurse their night sweats and hot flushes were almost twice as easy to cope with. They also experienced significantly improved quality of sleep and reduced levels of depression and anxiety.
Led by Professor Deborah Fenlon from the University of Swansea, in collaboration with the Southampton Clinical Trials Unit at the University of Southampton, the trial involved 127 women from six UK hospitals. All participants had primary breast cancer or DCIS (ductal carcinoma in situ), an early type of the disease, and were experiencing severe and frequent hot flushes or night sweats.
The participants attended six 90-minute sessions, delivered by 11 different breast care nurses who had been specially trained, by a clinical psychologist, to deliver CBT. The sessions covered topics including stress management, paced breathing, improved wellbeing and strategies for managing the specific side effects of hot flushes, night sweats and disrupted sleep.
The Southampton Clinical Trials Unit (STCU) was responsible for the design, running and analysis of the phase 3 randomized controlled trial, run at six UK hospitals.
The trial team were able to support the hospitals involved in how to deliver the trial procedures and developed working practices to ensure the trial was conducted to a high standard. The team also used questionnaires and conducted interviews with patients to collect feedback and data from the women involved on how successful the therapy had been.
Jacqueline Nuttall, Head of Trial Management for the SCTU, said:
"The Southampton Clinical Trials Unit has vast experience in running not only trials of new drug therapies and treatments, but also in behavioral and non-medical interventions that can improve quality of life for more people living with diseases such as breast cancer."
"We are delighted to have been able to run this trial in collaboration with the University of Swansea and with the support of Breast Cancer Now, which has shown that CBT can be delivered successfully by breast care nurses and can help to significantly reduce the symptoms of menopause for women with breast cancer. We are now looking at whether CBT can be used in prostate cancer patients to help reduce the burden of hot flushes that can have a detrimental impact on their lives."
Once the pressures on the NHS start to ease, and capacity and resource has been considered, Breast Cancer Now would like to see Trusts and Health Boards across the UK support breast care nurses to deliver group CBT to patients suffering with these menopausal side effects of treatment. Where this intervention is possible it will improve quality of life, and critically, help women to continue treatment that helps reduce the chances of their cancer coming back.
Professor Myra Hunter from the Institute of Psychiatry, Psychology and Neuroscience at King's College London, who developed the group CBT and trained the nurses in the trial, said:
"In previous trials we have found that group CBT delivered by clinical psychologist, is an effective way to alleviate menopausal symptoms for women who have undergone breast cancer treatment. There are clear advantages for women to access this support from nurses who they may already know, so it is a considerable step forward to demonstrate that this therapy is just as effective when delivered by trained breast care nurses. We have a published treatment manual and a training course with the British Menopause Society so that this therapy can reach more women who might benefit from it."
Dr. Simon Vincent, Director of Research, Support and Influencing at Breast Cancer Now, said:
"Menopausal symptoms, such as hot flushes and night sweats, can profoundly impact quality of life for women with breast cancer. It's hugely exciting to see that cognitive behavioral therapy delivered by a breast care nurse can help to spare these women, who've already had the difficult experience of a breast cancer diagnosis, this further anguish.
"The COVID-19 pandemic has thrown us into unprecedented times. But one thing that remains the same is the critical need for us to strive, through research, to find ways to prevent breast cancer and save lives, and equally to make discoveries that mean the 600,000 people living with the disease right now live as well as possible.
"We appreciate that the NHS is working tirelessly under immense strain right now, but hope that when pressures on breast care nurses begin to ease the findings of this innovative study lead to CBT being made available to help women affected by breast cancer to enjoy a better quality of life.
"Our world-class research is only possible thanks to public support. Due to the impact of COVID-19 our fundraising income is projected to drop by 43% in this financial year, meaning we are less able to fund new research that could transform the lives of people affected by breast cancer. We need your support now more than ever."
Natalie Richards, 39, mum-of-two, from London, who was diagnosed with triple negative breast cancer in April 2019 and experienced intense hot flushes and night sweats during chemotherapy. She said:
"I was shocked to be told I had breast cancer. Treatment began pretty quickly and as soon as I started chemotherapy my periods stopped. I hadn't been aware of the side effects I'd experience.
"I had hot flushes all through the day and night. It felt like every half an hour. I was breaking out into full sweats no matter the time or weather, on top of all the other side effects of my chemotherapy, yet this side effect had never been mentioned or discussed with me. When I explained I was struggling with hot flushes I felt this was dismissed, without any advice around how I could try to ease this distressing side effect.
"I became very down and anxious with my hot flushes and night sweats being all consuming and overwhelming. I was so embarrassed when it happened in public. I don't know how I managed, but I just tried to take one day at a time and focusing on my daughters helped me push through. It was the best part of a year before these symptoms eased off.
"I knew less about these menopausal symptom side effects and they seemed overlooked; yet for me they were just as distressing as hair loss, perhaps more so because they were so unexpected. I had such a wonderful breast care nurse, and I think if she'd been able to provide me with some support specifically for my menopausal symptoms that could've made a huge difference."
Provided by University of Southampton