Title: A multicentre randomised controlled trial (RCT) of a self-help cognitive behavioural therapy (CBT) intervention to reduce the impact of hot flush and night sweat (HFNS) symptoms in men with prostate cancer undergoing androgen deprivation therapy (ADT): MANaging symptoms during prostate CANcer treatment (MANCAN2)
Funder: Department of Health and Social Care

Abstract: Research question: Can a self-help cognitive behavioural therapy intervention, delivered through the existing prostate cancer nurse specialist (CNS) team, reduce the impact of hot flushes and night sweats (HFNS) in men with prostate cancer receiving androgen deprivation therapy? Background: Prostate cancer is the commonest male cancer in the UK. Because of a rising incidence (currently ~48,000 pa), and improving survival rates, more men will live with and beyond a prostate cancer diagnosis. Androgen deprivation therapy (ADT) is a common hormonal treatment for prostate cancer which about half of patients receive at some point. However, it may be associated with troublesome side effects that include HFNS. Up to 80% of men undergoing ADT suffer HFNS, which can be frequent and severe and cause a negative impact on quality of life. HFNS can occasionally be so significant that patients stop ADT altogether despite an increased risk of either disease relapse or reduced survival. Unfortunately, there are few established effective treatments for men with HFNS. Our previous research established that cognitive behavioural therapy (CBT) can significantly reduce HFNS in men with prostate cancer when delivered by a clinical psychologist (in a single centre study), and in women with breast cancer when delivered by breast care nurses. Primary aim: To evaluate the effectiveness of a self-guided CBT intervention compared to 'treatment as usual' (TAU), at reducing the impact of HFNS in men with prostate cancer undergoing ADT, when delivered by the patient s existing prostate cancer CNS team in a multi centre study. Objectives: Our primary objective is to determine whether there is a difference in HFNS symptoms between those receiving self-guided CBT compared with TAU using the Hot Flush Rating Scale (HFRS) at 6 months post randomisation. Secondary objectives, measured at 6 weeks and 6 months, include HFNS frequency, HFNS beliefs and behaviours, quality of life, other symptoms including anxiety, depression, mood and sleep, compliance with ADT, and a health economics assessment of this intervention. Methods: 150 prostate cancer patients undergoing ADT and experiencing problematic HFNS will be recruited from seven UK NHS sites. They will be randomly assigned to either a 4-week self-help CBT programme or treatment as usual. The programme consists of an instructional booklet including information and exercises addressing stress management, paced breathing and cognitive/behavioural strategies to improve wellbeing and for managing hot flushes, night sweats and sleep, and a CD demonstrating relaxation exercises. Participants receiving CBT will attend pre- and post-programme group meetings facilitated by trained members of the existing prostate CNS team. Recruited groups of 12-16 men will be block randomised in groups of 6-8 to either CBT or TAU. Timelines for delivery: Set up by month 12, recruitment and follow up by month 27, analysis and dissemination by month 36. Anticipated Impact and Dissemination: We intend to provide evidence to substantiate, or refute, a move towards adoption of this approach by existing NHS prostate cancer CNS teams. Results will be disseminated through the scientific community by peer reviewed publication and conference presentation.

Lay abstract: Background: Prostate cancer is the most common cancer in UK men. 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. Aim: To 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. Methods: We will recruit 150 men suffering from hot flush 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. The men assigned to the self-help programme will be given an instructional booklet consisting of information and exercises to help manage symptoms and improve wellbeing. These exercises will cover stress management, paced breathing and cognitive/behavioural strategies. There will also be a face-to-face meeting before and after the self-help programme to help facilitate the process. Our main objective is to assess the severity of symptoms before the programme and then at 6 months after the programme to see if CBT has a positive and sustainable effect for patients. All 150 men will complete validated self-reported questionnaires measuring other important factors such as quality of life, sleep, mood, beliefs and behaviours before the programme, 6 weeks later and again after 6 months follow up. Patient and public involvement: We have included a member of the Prostate Cancer Support Organisation (PCaSO) within our Trial Management Group. He has helped review, challenge and influence our proposal, including recruitment and trial design. He will remain part of our Trial Management Group as we implement, deliver, analyse and report the trial. Dissemination: We will communicate the results of our trial to the scientific community through conference presentations and publications. We will keep the patient community up to date and involved throughout the entire process through PCaSO and other patient support groups. We also hope to demonstrate that our approach is suitable for routine use within the NHS.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: CANCER AND NEOPLASMS