Prostate cancer is the most common cancer among men in the UK and the incidence rate has increased in the last 30 years, mainly due to improvements in the detection of the disease. While the five-year survival rate in the UK is good, prostate cancer survivors often face unwanted treatment side-effects, which are particularly troublesome following androgen deprivation therapy (ADT) [1
]. Hot flushes and night sweats (HF/NS) are one of the main side-effects of ADT [2
]. They are transitory sudden periods of heat and sweating lasting between two and ten minutes, generally on the neck, face and torso [4
] The causal mechanism of HF/NS in men remains poorly understood, however, as for women, they are associated with changing hormone levels. A sudden change in levels of androgens is believed to alter the function of brain neurotransmitters (serotonin, noradrenalin and beta-endorphins), which in turn may lead to instability of the set point of the thermoregulatory centre in the hypothalamus. Intermittently, or in response to internal or external stimuli, the hypothalamus may down regulate body temperature by sweating and vasodilation [5
HF/NS in men are under-researched compared to those experienced by menopausal women or women following breast cancer treatments. Up to 80% of men having ADT report HF/NS and these tend to be more frequent and severe than those experienced by women [6
]. They can also be persistent; in one study over 40% of patients experienced HF/NS eight years post-treatment [7
]. HF/NS are associated with distress and reduced quality of life – particularly affecting sleep and physical well-being [8
]. The management of these symptoms presents a challenge to patients and clinicians alike. A recent systematic review of treatments for HF/NS in prostate cancer patients concluded that only a few treatments are available that are both effective and well tolerated, that more randomised controlled trials are needed, and that a priority should be the development of acceptable and effective treatments that are free from side-effects [5
We have developed non-medical interventions for HF/NS [9
] and a theoretical model of HF/NS [11
]. This work identifies a range of factors that can moderate the intensity and experience of HF/NS, such as certain triggers (e.g., hot foods and drinks), stress, and cognitive/behavioural responses. There is evidence from laboratory studies with women that stressors increase the general level of HF reporting [12
] and anxiety [13
]. Also, unhelpful cognitions - that is negative thoughts associated with embarrassment, social anxiety, feeling out of control and unable to cope - are associated with more problematic HF/NS and sleep problems [14
]. A psychological intervention, based on cognitive behaviour therapy (CBT) has been developed in the UK for women who have problematic HF/NS during the menopause transition [9
] and for women following breast cancer treatment [10
]. This has been found to be effective in reducing hot flush problem-rating (the extent to which they are problematic) in two recently published RCTs with breast cancer patients (MENOS1) [15
] and well women (MENOS2) [16
]. In MENOS2 both group CBT and guided self-help CBT were significantly more effective than no treatment, suggesting that a self-help format may be acceptable and beneficial. There is evidence that prostate cancer patients might prefer individualised informational support [17
]; furthermore telephone support services are well received by men and guided self-help can be accessed by men living at a distance or who are housebound.
This study aims to evaluate the effectiveness of guided self-help to alleviate HF/NS in men following treatment for prostate cancer. Guided self-help is compared to usual care (access to nurses and/or telephone support service) in a randomized controlled trial, using both physiological (sternal skin conductance [SSC]) and subjective measures of HF/NS and a 6 month follow-up. We hypothesise that guided self-help is more effective than usual care in reducing HF/NS problem-rating. Secondary analyses will also examine the effects of the treatment on HF/NS frequency, mood and quality of life (QOL). Mediating variables, including physiological HF/NS, beliefs and behaviours, are examined. A one year follow-up will be carried out by telephone off trial to estimate longer term outcomes. If effective, the treatment can be promoted by publication of the treatment manual and by training and supervising clinical nurse specialists in the application of the treatment.
The trial is funded by the Prostate Cancer Charity, and registered with the UK Clinical Research Network (UKCRN; Trial ID: 10904). NHS REC approval has been granted (South East London 2 REC, ref: 11/LO/1114) and local ethics and R&D approval has been obtained for recruitment of prostate cancer patients from all hospitals in the South East London Cancer Research Network (SELCRN).