Over 30% of prostate cancer patients are reported to develop recurrent disease following primary radiotherapy (Zietman et al, 2010). For some patients with radiation-recurrent prostate cancer, salvage (second-line) prostate cryotherapy can be a potential curative option. As a result, these minimally invasive treatments have gained popularity as alternatives to androgen deprivation therapy (ADT), which in the past was the only option for the majority of patients with this type of prostate cancer. ADT does not have a curative intent and it can potentially have adverse effects, such as cardiovascular toxicity and metabolic syndrome related to the loss of androgens (Pivonello et al, 2019). For a minority of patients, salvage prostatectomy may be considered, but it is highly challenging and performed only in a handful of centres worldwide (Peters et al, 2013). It also has a very high intrinsic risk of complications resulting from radiation-induced vasculitis, fibrosis and tissue plane obliteration, leading to significant risk of rectal injuries, anastomotic strictures and urinary incontinence (Sivaraman et al, 2018).
The national Scottish prostate cryotherapy service aims to deliver a high level of care to eligible patients and their families. For these patients, it offers the chance of second-line treatment with intent to cure. All patients across Scotland, regardless of geographic location and treatment history, are eligible for consideration. The service accepts patients who have been previously treated with both external beam radiotherapy and brachytherapy. Patients who have had a short, or defined, period of ADT are eligible as long as there is no evidence of biochemical progression signified by persistent rise in the serum levels of prostate specific antigen (PSA) because patients who develop castrate resistent prostate cancer will not benefit from cryotherapy.
Setting up the service
The service's mission is to deliver salvage prostate cryotherapy to eligible patients with equity across Scotland. To achieve this, early referral from the local teams is critical. Since the service was designated in 2008 (and launched in 2009), opportunities to work with colleagues (urology, medical and clinical oncology teams) have been sought to provide equal access across the country. The service also supports colleagues across Scotland to educate the medical community about salvage prostate cryotherapy via an intranet and internet websites. To achieve user-friendly websites that contained the relevant clinical information for both clinicians and potential patients guidance and education were required for the website design—the clinical nurse specialist was instrumental in undertaking this and designing both sites. The websites provide information on the possible side effects of the treatment as well as offer a means to download a referral form. The websites also document current audit projects as well as links to other useful sources of information. In order to support clinical visits the service is required to produce patient information leaflets; one for patients considering prostate cryotherapy, another for patients who have undergone treatment with prostate cryotherapy and a third leaflet for the GPs of the patients who had been treated. In developing these leaflets, the intention was to provide both patients, families and GPs with information on possible complications, as well as ensuring a seamless transition from secondary to primary care. To develop the written literature, the clinical nurse specialist collaborated with another cryotherapy clinical nurse specialist in the UK, used information from prostate cryotherapy equipment manufacturer and carried out a systematic literature review on prostate cryotherapy. The information leaflets were subject to a rigorous quality assurance process with the local health board to ensure they met the required standards.
The target patient group for the Scottish prostate cryotherapy service includes individuals with a known diagnosis of prostate cancer who have developed cancer recurrence following previous radiation-based therapy (either with external beam radiotherapy or permanent insertion of radio-isotope implants, ie brachytherapy). Some of these patients may have a period of ADT, including neoadjuvant and/or adjuvant treatment in combination with radiotherapy. For neoadjuvant treatment, ADT is typically used for 3-6 months, while adjuvant ADT is often given for 2-3 years. Both are acceptable to enable patients to be considered for salvage prostate cryotherapy.
Referral criteria for second-line prostate cryotherapy has not changed since the inception of the national prostate cryotherapy service, and remain in total agreement with international consensus for second-line prostate cryotherapy:
The cryotherapy clinical nurse specialist
Clinical activities
The benefit of the clinical nurse specialist role in prostate cancer care as well as wider cancer care has been well-documented. Studies show clinical nurse specialists to be associated with reductions in length of hospital stay, readmission rates, emergency visits, as well as improvements in staff nurse knowledge, functional performance, mood state, quality of life, and patient satisfaction (Newhouse et al, 2011). However, their benefit in terms of cost-effectiveness remains mixed according to a recent systematic review (Salamanca-Balen et al, 2018). In 2014, the National Cancer Patient Experience Survey demonstrated that patients with cancer who have access to a clinical nurse specialist report better experiences and understanding of the disease (NHS England, 2014). The National Institute for Health and Care Excellence (NICE) advocates that men with prostate cancer should be supplied with information tailored to their own needs, supported by written material (NICE, 2014).
The clinical nurse specialist embedded in the cryotherapy service plays a crucial role in counselling and educating patients and is the named patient advocate throughout the patient journey from pre-treatment to follow-up. O'Shaughnessy (2015) concluded that the clinical nurse specialist was most valued by prostate cancer patients during treatment decision-making. Clinical nurse specialists also play a vital role in ongoing and long-term care. Before the first consultation, the clinical nurse specialist liaises with the referring clinicians to ensure that all required clinical information is supplied prior to patients attending clinic. At this stage, patients who are deemed unsuitable can be referred back, and so will not have wasted a journey. All referrals are logged onto a dedicated prostate cryotherapy database. This is used as an audit tool.
The clinical nurse specialist offers a further consultation directly after the consultation with the consultant in charge. The purpose of this is to introduce herself and her role to the patient and his family, and to offer further information and clarity about the treatment, side effects and follow-up care. It is recognised that patients speak differently with nurses compared with doctors and may ask different questions. King et al (2015) concluded that there is a need for improved access to clinical nurse specialists in order to improve cancer patient experiences and fully meet each patient's needs.
Each new case being considered for prostate cryotherapy is discussed at the local multidisciplinary team meeting before treatment. It is the responsibility of the clinical nurse specialist to provide a summary of each patient being considered for treatment. In doing so it may be argued that the clinical nurse specialist is encouraging assessment of the holistic needs of patients. Once a patient is accepted for treatment, the clinical nurse specialist collates the clinical information into a concise patient checklist, which easily identifies any missing information or abnormal results. This is supplied to the consultant before the patient's admission. This prevents short-notice cancellations by picking up any anomalies in preoperative blood results, ECG, or highlights any crucial missing clinical information. The clinical nurse specialist is responsible for maintaining and updating both written and virtual information via the websites to ensure accuracy. It is important that patients and clinicians can access up-to-date and accurate information about prostate cryotherapy. Besides printed information, access to online resources assists with informed consent. This is particularly relevant for this service because the patients come from different parts of Scotland. A recent study reported geographical location to be a perceived barrier to patients with prostate cancer accessing care, due to the long distance required to travel (Chambers et al, 2018). One patient made a referral to the service based on the information he had read about prostate cryotherapy online.
Following discharge from hospital after successful treatment, the cryotherapy clinical nurse specialist maintains a close contact with patients, and conducts telephone follow-up in the interval between treatment and catheter removal (around 7 days). The clinical nurse specialist is also responsible for conducting patient follow-up after treatment. These consultations are carried out either face to face in a clinic setting or via the telephone, depending on geographical location. During the post-treatment consultation, the clinical nurse specialist discusses the treatment response based on the patient's most recent PSA levels and assesses for evidence of any possible side effects. All records of consultations and results are uploaded to the cryotherapy database.
The clinical nurse specialist also functions as a clinical expert in the field of prostate cryotherapy. Patients are often signposted to the clinical nurse specialist with questions around the procedure, side effects or follow-up care. Such direct contact allows the early detection of any problems and limits visits to GPs, out-of-hour clinics, and unplanned hospital readmission. The direct point of contact via the clinical nurse specialist is useful in addressing any immediate concerns and averting possible complications. In the early days of the service one patient had a significant complication, which was caused by repeated failed catheterisation after he had been discharged from his initial treatment. To minimise future risk of the same complication the clinical nurse specialist developed a small warning card, indicating that the patient had been treated with prostate cryotherapy; urinary catheterisation, if required, following cryotherapy treatment could be technically difficult. Therefore, the recommendation on the ‘warning’ card is for healthcare personnel to attempt urethral catheterisation only once and, if unsuccessful, to undertake suprapubic catheterisation. Patients are issued with the warning card on discharge.
Providing psychological support to patients and families and assisting with their treatment choice is a fundamental role of the clinical nurse specialist. The cryotherapy service maintains active contact with patients to ensure attendance at all appointments, minimising ‘do not attend’ rates and maximising use of all resources, as well as allowing patients to feel valued and cared for following treatment. The clinical nurse specialist plays a key role in the follow-up care of patients, thus freeing valuable consultant time. Although nurse led, the follow-up care is regularly discussed and agreed with the consultant based on serum PSA levels and any underlying issues that patients may have.
Educational activities
During the setting up stage, the theatre team was closely involved in establishing the necessary standard of procedures for performing cryotherapy (Figure 1). A formal training session was organised for both the lead surgeon and the designated theatre team, and involved the demonstration of the cryotherapy system as well as the theory behind the principle of cryoablation, generation of freezing effect with the use of ‘cryo’ needles (or rods).
The cryotherapy clinical nurse specialist has conducted staff education sessions on salvage prostate cryotherapy to promote awareness of the treatment. These have been well received by ward and theatre staff. On average, one or two training sessions are organised every 12-18 months, and approximately 5-6 nursing staff attended each event. The events were considered to be very helpful by all those who attended.
Theatre staff continue to be trained and updated in the processes for delivering cryotherapy. The skills and experience gained have been used to facilitate the local renal cryotherapy service run by a radiologist and urologist within NHS Greater Glasgow and Clyde. This knowledge transfer has allowed optimal use of local expertise and the development of complementary services. The service has been successful in engaging with theatre nurses, as well as supporting assisting staff in theatre, and continues to seek opportunities to expand the pool of theatre nursing team members being trained in performing the cryotherapy procedure. However, the service continues to be limited by the number of referrals. The clinical nurse specialist and lead consultant aim to engage regularly with referring clinicians, and so have consequently visited outlying regions of Scotland to carry out education about the treatment, efficacy and side effects. The service has also provided education on cryotherapy to a patient support group, thus providing an opportunity to engage directly with potential service users.
Audit and research activities
The cryotherapy service continues to audit patient outcome through the use of validated questionnaires. These include the International Prostate Symptom Score (IPSS) (Sarma and Wei, 2012), quality of life, and erectile function. Patients complete these before treatment to obtain a benchmark and then again at subsequent follow-up consultations. The service also audits the role of the clinical nurse specialist through a questionnaire supplied to patients at their first post-treatment consultation. The limitations of this are acknowledged, given that this is an unvalidated tool and issued by the clinical nurse specialist. Patients acknowledge the support given by the clinical nurse specialist.
The Scottish prostate cryotherapy service has been instrumental in working with centres across the UK to set up standard procedures for carrying out cryotherapy as well as approaches to harmonise the investigations of patients with biochemical relapse following previous primary radiation therapy for prostate cancer. It initiated data sharing with two of the largest centres for salvage prostate cryotherapy in the UK, namely the Royal Surrey County Hospital and Sunderland General Hospital, and the findings were published in 2013 (Ahmad et al, 2013). The report confirmed the efficacy of prostate cryotherapy for cancer management in patient cohorts, with a highly acceptable side-effect profile. In addition, the service was able to pioneer a potential way to predict the relative risks of patients undergoing prostate cryotherapy developing urinary symptoms following treatment.
A collaboration with Health Economics colleagues has also been published (Boyd et al, 2015). This study carried out a head-to-head comparison between cryotherapy and androgen deprivation therapy in a formal health economics analysis. It found that delaying hormone treatment by just over 3 years lead to improvements in quality of life that were cost neutral. The delay of hormone treatment by more than 3.2 years would begin to save money following cryotherapy. This is an important report and has implication on cost-to-efficacy analysis on delaying androgen ablation therapy by a second-line therapy, which is not restricted to total prostate cryotherapy. It may well be that, for patients with focal recurrence of prostate cancer, limited prostate cryotherapy directed to the tumour recurrence may be adequate to manage this.
As the service evolved, the database increased in size and it became less easy to ‘probe’ the data for specific information or answer a specific audit question. Therefore, the clinical nurse specialist liaised with the clinical audit facilitator from the clinical audit department (NHS Greater Glasgow and Clyde Health Board) to refine the patient database within the hospital intranet system so that data can be extracted with ease for reporting purposes, as well as for supporting specific audit projects. The clinical nurse specialist is responsible, along with the wider clinical team, for documenting regular service reports to NHS National Services Scotland.
Treatment efficacy of prostate cryotherapy is typically guided by the assessment of serial serum levels of PSA. This is in keeping with other treatment modalities for prostate cancer, including surgery and radiation-based therapy options. In the cohort of treated patients, the median lowest PSA levels following treatment with cryotherapy were 0.7 ng/ml, compared with a pre-treatment median PSA level of 5.6 ng/ml. Using a two-tailed Mann-Whitney t-test, the difference between pre-treatment and nadir PSA levels was highly significant with P<0.0001. It is worth noting that a nadir PSA of below 1 ng/ml has been reported previously to be a good indicator of prolonged disease-free survival. In addition, the assessment of urinary function was carried out using validated IPSS questionnaire, with the scores indicating the ‘bothersome’ nature of individuals' urinary symptoms. The median values of the pre- and post-treatment IPSS scores were 7 and 11. Although statistically significant, IPSS scores of around 11 do not represent clinically significant symptom scores that warrant intervention. Most patients are in fact quite happy with their micturition status.
Limitations of the role
Currently, the role of the clinical nurse specialist is the only one of its kind within the UK and, as such, it is a highly specialised role. Due to the limitations created by low number of referrals and the highly specialised nature of the treatment, input from the clinical nurse specialist can sometimes be on an ‘as required’ basis. Importantly, the clinical nurse specialist works as part of the wider uro-oncology clinical nurse specialist team, thus enriching the learning opportunities across the team. There are, however, challenges around succession planning due to the specialised nature of the role and the possibility of competing clinical priorities as part of the team.
Conclusion
The role of nursing continues to evolve in different clinical specialties. The service's cryotherapy clinical nurse specialist was instrumental in setting up the foundations of the service, and provided patient support information as well as information for clinical colleagues. The clinical nurse specialist serves a critical role in the designated Scottish prostate cryotherapy service, acting as an expert clinical resource, an advocate for patients and an educator for colleagues, in addition to having responsibility for auditing outcomes on a regular basis. The clinical nurse specialist provides an invaluable service to patients, clinicians and colleagues in wards and theatres within the domains of clinical expertise, audit, research and education.
Since the service began, the role of the cryotherapy clinical nurse specialist has developed to enable autonomous working with clinical freedom for decision making, being supported by a strong educational background and clear agreed clinical boundaries. This serves to meet the needs of a population of recurrent prostate cancer patients spread across a wide geographical area. The clinical nurse specialist is pivotal in not only the patient decision-making process in relation to treatment decision, but also in undertaking flexible, supportive follow-up care in a manner that meets individual patient requirements. For continued success, there requires to be some progress in relation to succession planning as well as protected time for learning.