MANCAN2
Research type
Research Study
Full title
A multicentre randomised controlled trial of virtual self-help cognitive behavioural therapy to MANage the impact of hot flush and night sweat symptoms in patients with prostate CANcer undergoing androgen deprivation therapy (MANCAN2).
IRAS ID
304500
Contact name
Simon Crabb
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
Duration of Study in the UK
2 years, 3 months, 1 days
Research summary
Hormone therapy medication is widely used to treat prostate cancer. It works by blocking or reducing the amount of testosterone in the body. This stops or slows down the cancer's spread. While effective as a medication, 80% of men suffer from Hot Flushes and Night Sweats as a result of taking it. These side effects can occasionally be so troublesome that some men decide to stop taking the medication allowing the cancer to grow.
Unfortunately, there are few established effective treatments for men with Hot Flushes and Night Sweats. Our previous research has shown that cognitive behavioural therapy (CBT), a type of talking therapy, can help both men and women manage hot flush and night sweats in a positive way by changing how they think and behave.
This study will evaluate how effective a self-help CBT programme is in reducing the impact of hot flushes and night sweats in men taking hormone therapy for prostate cancer. This will be delivered by a trained member of the existing prostate cancer nursing team.
We will recruit 150 men with a diagnosis of prostate cancer currently receiving hormone therapy and experiencing problematic hot flushes and night sweats from seven hospitals around the UK. Half will be randomly assigned to a 4-week self-help CBT programme and the others will receive treatment as usual.
Participants randomised to the self-help programme will be given a cognitive behavioural therapy booklet to work through consisting of information and exercises to help manage symptoms and improve wellbeing. There will also be two virtual group workshops delivered by the cancer nurse specialist team. Men in this arm will also receive a CD/ audio file demonstrating breathing and relaxation exercises.
All participants will complete study questionnaires at baseline, 6 weeks and 6 months.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
21/WM/0259
Date of REC Opinion
16 Dec 2021
REC opinion
Further Information Favourable Opinion