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)

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.