Summary OBC:

Patients with pelvic radiation disease currently outnumber the number of patients who suffer with Crohn’s disease. However, this disease is one not only caused by our interventions but can often be easily corrected or at least improved by following a standard algorithm of care. Hence, this service could be carried out predominantly by a clinical nurse specialist with supervision from a gastroenterologist.

 

Summary of Proposal

The outline Business Case received funding through Rosemere for a 3year pilot to set up and trial an out-patient clinic to manage the late gastrointestinal (GI) effects of pelvic radiotherapy. The service is a symptom management service open to patients within the Lancashire and South Cumbria Cancer Network that are suffering with significant GI toxicity related to radiotherapy treatment for their pelvic cancer. The proposal is to request the provision of funds to allow this, well established service to continue. We believe the pilot has delivered a service that is cost-effective, accessible, and tailored to individual unmet needs.

The service is led by an Advanced Specialist Practitioner (ASP) with some support from a Consultant Gastroenterologist should complex patient management arise. The underlying evidence base for practice is the published guidance, The Practical Management of the Gastrointestinal Symptoms of Pelvic Radiation Disease (Andreyev et al, 2015). The guidance provides a detailed algorithm-based approach to management of GI symptoms to ensure consistent management of each symptom in a systematic way. The use of the algorithm was shown to be just as effective when used in clinical practice by specifically trained nurses as by gastroenterologists (Andreyev et al, 2013). By applying the algorithm, the late effects team investigate, diagnoses and manage complex GI presentations as well as offer support with self-help strategies following dietetic evaluation or specialist physiotherapy input. Providing self-help strategies has proven to be effective throughout the pilot with a significant percentage of our patients that have struggled to manage their chronic bowel symptoms for many years benefitting from these simple interventions alone. The service helps to empower patients by providing accurate information about late effects that will allow them to develop strategies to self-manage ongoing problems. Access to a dedicated dietitian and physiotherapist has shown to be integral to the service, as well as reducing the impact on these other disciplines by avoiding service to service referrals. The late effects core team work collaboratively with specialist clinic teams to ensure a multi-disciplinary approach to support patients. We complement and work closely with other services and pathways that are available to the patient, such as Patient Stratified Follow-up. There is a clear referral pathway accessible to both primary and secondary care providers to ensure that patients that are no longer under oncology follow up have access to this specialist service.

 

Pilot structure:

Band 8a ASP 1.00 WTE

Band 6 Dietitian 0.6 WTE

Band 7 Physiotherapist 0.04 WTE (1 clinic per month)

Band 3 A&C support 0.4 WTE

 

Clinics are held in Oncology outpatients and Dietetics, these are a combination of face to face, telephone or virtual clinics depending on patients’ preference and clinical requirements. This service model is easily replicated and is similar in design to other centres nationally, such as The Beatson, Glasgow and The Royal Marsden, London.

Rationale

Radiotherapy is used as a curative treatment for approximately 40% of pelvic cancers. As treatments are becoming increasingly effective the number of patients surviving cancer is also increasing. The NHS Long Term Plan (NHS England, 2019) reports that cancer survival is at the highest level it has ever been. Patients that undergo radiotherapy as part of their cancer treatment often do not experience side effects straight away. Radiotherapy can cause late effects which are delayed symptoms that patients experience after completion of radiotherapy treatment.

The term pelvic radiation disease (PRD) is used to describe the chronic symptoms that can arise following radiotherapy. Chronic symptoms are those lasting longer than six months or that begin years after treatment has completed. Patients that have pelvic radiation disease can experience a range of physical and psychological symptoms (Pelvic Radiation Disease Association, 2022). Physical symptoms are as a result of a series of pathological changes within the normal tissue which can result in the loss of control to normal bodily functions. The practicalities associated with the changes can mean patients are reluctant to leave their home for fear of needing to use the toilet without prior warning or the devastating fear of faecal incontinence. The psychological symptoms as a result can cause low mood, feelings of anxiety, hopelessness or depression. The burden of symptoms related to PRD can significantly affect the patient’s quality of life. Across the Lancashire and South Cumbria cancer network we are historically guilty of not meeting the needs of patients who have received pelvic radiotherapy and are suffering with debilitating side effects.

 

The Pelvic Radiation Disease Association recommend the highest priority routes to establish for late effects services are those with gastroenterology with a named Dr with an interest in late effects. The initial pilot has developed a service designed around this model. We know that managing patients with PRD requires a different approach to those with other forms of bowel pathology. With the correct diagnosis and treatment of disorders within the GI system resulting from PRD, treatments can be offered to correct the problem.

 

Impact On Patients

 

Prior to the implementation of the service patient’s suffering from late GI complications of pelvic radiotherapy could be referred across different disciplines to health care professional unaware of PRD, these patients may never receive the correct diagnosis or resolve their issues. A report from the Pelvic Radiation Disease Association and Jo’s Cancer Trust (2020) highlights this, stating that access to late effects services is sparce across the country due to a lack of funding, resources, and low awareness of PRD. Health care professionals can be reluctant to discuss late effects if there is no clear pathway for referral which would leave these patients with unmet needs and mismanagement.

 

 

Having a centralised team to manage GI issues of PRD has proven beneficial in our pilot service by reducing the impact on other health care services, particularly gastroenterology and colorectal surgical teams. Patients with severe GI effects of PRD are traditionally managed jointly via gastroenterology and colorectal specialists depending on the patient’s presentation. The Late GI Effects service receives referrals directly from these specialities for investigation and management of the symptoms believed to be as a result of PRD. This has the benefits of reliving some of the burden of long waiting lists within gastroenterology and colorectal surgery and provides the patients with prompt, direct access to services dedicated to manage their specialist symptoms.  

 

The key successes of this service to date have been:

  • Implementing a treatment option for management of radiation proctopathy using Sucralfate enemas. We treat patients that experience severe episodes of daily, rectal bleeding. We have achieved excellent success rates with sucralfate, with patients experiencing no further episodes of bleeding following a course of treatment. The Royal College of Surgeons (2017) recognise that sucralfate enemas may be of some benefit in secondary care for management of rectal bleeding and a suitable first line treatment with the overall aim of avoiding the need for endoscopic intervention, such as argon plasma coagulation (APC) and improving patient’s quality of life. Prior to our interventions some of these patients have required hospital admissions for blood transfusions due to low haemoglobin levels. Sucralfate enemas therefore is a cost-effective treatment that reduces emergency hospital admissions for patients requiring blood transfusions as a result of blood loss from rectal bleeding. It also reduces the need for invasive procedures, such as endoscopy and surgery, which carry an increased risk of serious complications for patients that have received radiotherapy treatment. (See Appendix 1, for case study detailing cost saving projections and treatment response with sucralfate enemas)
  • A business case was approved for SeHCAT scanning to be undertaken at RPH nuclear medicine department, which is used to diagnoses bile acid malabsorption (BAM). BAM is a common, yet underdiagnosed gastroenterology condition known to affect patients that have received oncological treatment (Gee et al, 2021). Patients diagnosed with BAM can be managed entirely within the remits of the Late Effects Team. The ASP can refer for SeHCAT scans, prescribe medications and manage on going monitoring through communications with primary care. The dietitian provides a dietary assessment and recommendations as a low fat diet can improve the management of BAM.
  • Medicines governance applications approved for the use of key medications used within the late effects service and information leaflets developed
  • Established Multi-disciplinary clinics that provide a joined-up approach to care, promoting a positive outlook by management of maintaining own health and wellbeing. 
  • Education to primary and secondary care about PRD, its management, and an awareness of the Late GI Effects service

 

Operational Benefits

 

The NHS Long Term Plan (NHS England, 2019) reports that cancer survival is at the highest level it has ever been. The number of people living beyond 5 years from initial cancer diagnosis is predicted to more than double between 2010 and 2030 (National Cancer Survival Initiative, 2013). However, 1 in 4 people who have been treated for cancer live with ill health or disability because of their cancer or treatment. The National Cancer Survivorship Initiative (NCSI) is a partnership between NHS England and Macmillan Cancer Support. The aim of the NCSI is to ensure that those living with and beyond cancer get the care and support they need to lead as healthy and active a life as possible, for as long as possible. Their NCSI report (2013) suggested that if there was a robust cancer survivorship support system in place there will be a minimum 20% reduction in volume, nationally, in hospital-based outpatient appointments.

Lancashire and South cumbia are one of the accelerator sites for a national NHE England approach, The Core20plus5, to inform action to reduce health inequalities. As an accelerator site we will share good health inequality improvement practices across the integrated care system. The Late GI Effects clinic is in an ideal position to contribute to this agenda as it accepts referrals from some of the most deprived areas in the North West of England. People living in the most deprived areas spend less time living in good health (The Health Foundation, 2019), which ultimately impacts on the local health care services. Our service focuses on improving quality of life; we understand the factors that influence a healthy lifestyle but also the factors that can prevent patients living a healthy lifestyle or making healthier choices. We provide health promotion during our consultations by addressing several public health agendas. We apply this knowledge when formulating personalised care plans for our patients.

 

Measurable Benefits

 

Generated Income………..

 

Modified Inflammatory Bowel Disease Questionnaire (IBDQ) Score- Completed pre- and post late effects interventions is used to evidence a significant reduction in in bowel symptoms on discharge.

  • A score >60= moderate to severe bowel symptoms, 70 = no bowel symptoms
  • A change in score of 6 or more in the IBDQ is a clinically relevant difference from a patient’s perspective (ORBIT, 2013)

 

Global impression of changes- a self-reported measure that reflects a patient’s belief about the effectiveness of the treatment.

 

 

Patient satisfaction results

 

 

Proposed structure:

Band 8a ASP 1.00 WTE

Band 6 Dietitian 0.6 WTE

Band 7 Physiotherapist 0.08 WTE (2 clinic’s per month)

Band 3 A&C support 0.4 WTE

 

Whilst currently the patients accessing the service predominantly require management of GI symptoms, we believe that over time, we will be able to expand the scope of our service to cover all pelvic late effects. Results of our local evaluation undertaken with patients 1year after completing radiotherapy for gynaecological cancers looked at the prevalence of other late effects within this cohort and has provided evidence of the clinical need. There was a high incidence of urinary symptoms, vaginal skin changes and women’s sexual health complaints, all of which can be addressed within our clinics utilising the combined knowledge and skills of the ASP and physiotherapist and with the already established links we have with other services within our network.