Service Colorectal Cancer Services Commissioner Lead Name Provider Lead Name Integrated Cancer System Period 2012/2013 Date of Review Annually 1. Purpose of Service 1.1 Aims and objectives of service The overall aim of the service is “to improve cancer outcomes through seamlessly delivered pathways, providing high quality care to patients with colorectal cancer throughout their journey”. The service will have the following objectives: Enhance the management of patients within the system, and actively manage the demand for secondary care and follow-up services ensuring patients have speedy access to appropriate treatment. Reduce variation in access to and experience of care through consistent application of best practice. Improve the patient experience. Provide clinical assessment and treatment within an Integrated Cancer System. Monitor and review agreed models of care and pathways for colorectal cancer patients across the Integrated Cancer Systems. 1.2 Whole pathway commissioning Improving cancer outcomes through seamlessly delivered pathways that run from prevention through to end of life care remains an important vision for commissioning cancer. It is important, therefore, that cancer site-specific pathways are collaboratively commissioned and delivered by providers working in partnership in an integrated system. This requirement is covered in Schedule 20 of the NHS Contract. The nature of the disease and its treatment means that there will be a plurality of providers. This approach ensures that all parties, commissioners, service users and providers recognise the whole patient pathway, the duty for partnership working and the need for seamless care across organisational boundaries. The ICS pathway groups will be responsible for managing the whole pathway, agreeing the approach to delivering clinical best practice pathways, and providing clinical leadership to coordinate delivery across the Integrated Cancer Systems. 2. Scope The service specification covers both early and locally advanced disease and advanced disease and covers the patient pathway from point of referral to follow – up / end of life care. 1 of 16 Providers will have in place co-morbidity assessment pathways to all relevant specialities that demonstrate minimised pathway delay. Co-morbidity pathways are not covered in the service description. 3. Service description – early colon cancer 3.1 Service model - general The required service model is outlined in the clinically effective pathway on map of medicine. In addition to this specification, there are a number of other criteria set out in NICE guidance that must be met by any provider offering services for colorectal cancer patients. Different elements of the cancer treatment might be delivered on different provider sites. Ref. Appendix 1 Commissioning best practice pathway for early colon cancer Ref. 1-3 Presentation People with bowel cancer may present either through screening or symptomatic routes. The existing screening programme involves offering Faecal Occult Blood Testing to people between 60 and 75 on a three-yearly basis. If the test is positive, the patient is seen and offered a colonoscopy. In addition a new one-off screening test is being rolled out between 2012 and 2015 to offer everyone a flexible sigmoidoscopy at age 55. The common symptoms of bowel cancer are rectal bleeding and change in bowel habit, which overlap with common benign conditions such as piles (which cause rectal bleeding) and irritable bowel syndrome and diverticular disease (which cause change in bowel habit). In order to diagnose bowel cancer earlier, the threshold for investigating these two symptoms in patients over age 40 should be lowered and GPs should have direct access to appropriate diagnostic tests for such patients that do not meet Two Week Wait criteria. Colonoscopy is the gold standard but as a screening tool is expensive, invasive and uncomfortable for the patient, and carries risk, especially in people with significant cardiac or respiratory morbidity. Recent literature shows that flexible sigmoidoscopy is an acceptable alternative as a first diagnostic test for people over 40 who present with rectal bleeding and/or change in bowel habit and who do not have any palpable abdominal mass or anaemia. ICSs should work with primary care to ensure that GPs have direct access to colonoscopy and flexible sigmoidoscopy for appropriate patients, with an in-built risk assessment before colonoscopy. Emergency presentation is the norm in many areas for up to 25% of patients with colorectal cancer. Yet outcomes from emergency presentation are considerably worse than for elective presentation. ICSs should monitor the rate of emergency presentation and work with GPs and other stakeholders to bring this down by improving planned early referral of symptomatic patients. Ref. 2-3 Referral Referral processes for patients with red flag symptoms should follow the current NICE 2 of 16 guidelines for colorectal cancer symptoms, ensuring that all patients are seen within 14 days of the referral. Ideally all patients referred for investigation to exclude colorectal cancer should have their first diagnostic test within 14 days and reported back to their GP within five working days of the test. Diagnosis to first treatment time should occur within 1 month (31 days). Treatment must commence within the 62 day deadline specified in the cancer waiting time targets for patients referred as Two Week Waits. This is calculated from the date of the decision to refer for assessment. The referral to treatment time for all fast track referrals should be delivered within 62 days. Any subsequent treatment should be delivered within 31 days. Ref. 4-5 Diagnostics Patients referred to secondary care for investigation of lower gastro-intestinal symptoms should be triaged so that the majority go straight to test. This requires appropriate patient information to be given so that they can understand what is involved and agree to the test. This is particularly important for invasive tests such as colonoscopy. Diagnostic colonoscopy, flexible sigmoidoscopy or CT colonography may be used for investigating symptomatic patients. Audit should be used routinely to quality assure these diagnostic tests. Results should reach the referring clinician within 7 days, and for tests that show a new cancer, the Colorectal MDT should be informed directly by the clinician reporting the test. A biopsy of any potential cancer should also be undertaken on the same visit (if colonoscopy or flexible sigmoidoscopy). A histopathologist should provide an interpreted biopsy result to the referring clinician within 7 days and also directly notify the Colorectal MDT of any new cancer diagnosis. Following diagnosis, all cancers or suspected cancers should be referred directly into the specialist pathway and all other findings should be referred back to the GP. If the testing suggests cancer, a clinician should inform the patient at the diagnostics appointment and arrange staging tests. Ref. 6 Staging tests Contrast enhanced CT of the chest, abdomen and pelvis should be undertaken to stage the disease. No further routine imaging is needed for patients with colon cancer. Ref.6 MDT ICSs should ensure that all MDTs are given a central role in coordinating patient care. All patients should be assigned to a named colorectal nurse specialist. The issues of patient fitness and co-morbidities should be clearly documented and inform the MDT decision on advice regarding best treatment for an individual patient. Surgeons should carry out a minimum of 20 colorectal cancer resections with curative intent each year. All patients should be offered the option of laparoscopic resection of their colorectal cancer. The MDT should record disease staging based on diagnostic and staging tests before surgery, and correct this if necessary after surgery and pathological analysis of the specimen. The MDT should record the percentage of patients offered then subsequently entered into clinical trials. 3 of 16 Ref. 8 First outpatient The first outpatient appointments pre-surgery is to inform the patient of the outcomes of the investigations and the proposed management. Patients should be invited to bring a relation or friend to this meeting, and should be offered written information as well as oral. Patients may require more psychological support at this stage. A holistic needs assessment should be undertaken whereby the patient should have an agreed, written care plan, recorded by a named healthcare professional (or professionals), with a copy sent to the GP and a personal copy given to the patient. Consideration of any requirement for pre-operative nutritional support or treatment of anaemia should be considered at this stage. A pre-operative assessment should be undertaken, including CPEX if necessary and ECG. All patients requiring stoma, either permanently or those who may require a temporary stoma, should be seen by a specialist stoma nurse and this should be undertaken at the earliest opportunity pre-operatively. Ref. 9a-c Surgery Non-complex colorectal cancer surgery should be available locally to patients. This includes laparoscopic resection. Surgery should be done by surgeons specialising in colorectal surgery, acting within a MDT. Patients should be offered surgery using laparoscopic techniques, where appropriate. All colorectal multidisciplinary teams should include at least one fully trained laparoscopic surgeon. Providers will participate in the Inpatient Management Programme outlined in the Cancer Reform Strategy. This includes implementation of enhanced recovery programmes that lead to improved outcomes and reduced length of stay after colorectal surgery. Enhanced recovery after surgery programmes should be adopted by all surgical and anaesthetic teams treating patients with colorectal cancer. A histopathologist should provide a report in the nationally agreed format within 7 days and examine at least 12 lymph nodes. The patient should be discussed again at the MDT with this information to provide advice about further treatment that may be offered. Specialist surgery service co-dependencies Specialist colorectal cancer surgery should be collocated with specialist bladder and prostate surgery and liver surgery, as set out in the cancer co-dependencies framework. Specialist colorectal cancer surgery must be collocated with the following support services, as set out in the cancer co-dependencies framework: specialist imaging (for CT scan), HDU, CNS support, and dietetics. There are a number of additional desirable service collocation requirements for the specialist surgical service and the ICS will agree service configuration and location with commissioners. Ref. 11 Second outpatient Patients should attend a post-operative clinic to receive results and discuss treatment options. The OPA may be surgically led or joint with oncology. The patient should then be referred to a clinical or medical oncologist for further treatment if needed. 4 of 16 Ref. 12a-12b Adjuvant chemotherapy Where appropriate, chemotherapy should be delivered in a community setting and close to home. Adjuvant chemotherapy or radiotherapy should commence between 4-8 weeks after surgery, and as soon as the patient is well enough to have this treatment. Ref. 13-15 Follow-up, survivorship, End of life care With the emerging national guidance cancer care pathways must include new models of long term follow up and survivorship care. Patients who have had curative treatment have different follow-up needs from those who have only been palliated. The first purpose of follow-up is to ensure recovery from initial treatment. Patients should be followed up to assess recovery from colorectal surgery including wound healing and bowel function. This applies to all patients. The second purpose is to seek early signs of recurrence in those who have had curative treatment and who are fit for further treatment. Whether a patient should be included in this follow-up programme or not should be agreed with them after completion of treatment. For these patients CEA blood testing should have been done once pre-operatively and should be done at 3 monthly intervals for three years then six monthly until five years after surgery. Any new rise in CEA should prompt urgent CT scan of chest, abdomen and pelvis followed by rapid OPD review and discussion at the MDT. If tests are negative and CEA continues to rise then a PET CT should be requested. These patients should also have 2 planned CT scans in the first 2 years after surgery (three years if had neoadjuvant treatment first). If patients have not had a full colonoscopy before curative surgery, they should have one within a year afterwards and then five yearly to age 75. The supportive and palliative care IOG should be implemented in London. All patients should be offered a range of supportive care including psychosocial support and individualised patient information. A discharge holistic assessment should be made to ensure supportive care requirements are considered. Recurrence and metastatic findings require fast-track referral to a colorectal MDT core member and presentation at the colorectal MDT as soon as a diagnosis is known. This is particularly important for patients with colorectal liver metastases, some of whom can expect to have curative liver surgery. Where appropriate, and in line with national guidance, all patients will have access to End of Life Care Services. All pathways and specifications will be assumed to link to the separate pathway and specification for End of Life Care. 4. Service description – late colon cancer Ref. Appendix 2 Commissioning best practice pathway for late colon cancer All service structure elements described for early disease and relevant to the late colon cancer pathway should be followed. In addition: - PET scan may be undertaken to investigate for metastases only if proposing 5 of 16 - - radical surgical treatment and where sequential standard is equivocal. Patients with potentially operable metastatic disease should be discussed at a specialist hepatobiliary MDT. The decision on operability should be made by the hepatobiliary MDT. Patients with inoperable metastasis should be considered for palliative chemotherapy and referred to a palliative care team where necessary. 5. Service description – emergency admissions Ref. Appendix 3 Commissioning best practice pathway for colon cancer presented as an emergency All service structure elements described for early and late disease and relevant to the emergency pathway should be followed. In addition: - patients should be assessed, resuscitated, investigated and have relief of obstruction within 48 hours - patients with suspected perforation in relation to emergency presentation of bowel cancer should have emergency surgery within 6 hours. - Emergency surgery should be performed by, or under the direct supervision of, a designated consultant colorectal surgeon. - The use of a stent is a decision that should be made by a core member of the MDT and should be inserted within 48 hours to relieve intestinal obstruction. - A partial enhanced recovery programme should be implemented as appropriate. 6. Service description – early rectal cancer Ref. Appendix 4 Commissioning best practice pathway for early rectal cancer All service structure elements described for colon cancer pathways and relevant to the early rectal cancer pathway should be followed. In addition: - Offer magnetic resonance imaging (MRI) of the pelvis to assess the risk of local recurrence determined by anticipated resection margin, tumour and lymph node staging, to all patients with rectal cancer. - Offer endorectal ultrasound to patients with rectal cancer if MRI shows disease amenable to local excision or if MRI is contraindicated. - Surgeons performing rectal surgery should be adequately trained in TME (Total mesorectal excision). Patients diagnosed with early rectal (T1) cancer should be assessed for suitability for complete local removal of the tumour via Trans-anal Endoscopic Microsurgery (TEMS) or the Trans-anal rectal (TAR) excision technique. - Where APE is deemed to be the appropriate operation, surgery must include that part of the levator muscles that envelopes the distal mesorectum (Extra-levator abdomino-perineal excision (eLAPE)) plus the anal sphincter complex. 7. Service description – late rectal cancer 6 of 16 Ref. Appendix 5 Commissioning best practice pathway for early rectal cancer All service structure elements described for colon cancer pathways / early rectal cancer pathway and relevant to the late rectal cancer pathway should be followed. In addition: - all patients with late rectal cancer should have access to preoperative downstaging therapy with chemo-radiation followed by a second pre-operative MRI scan. - Surgery after such downstaging therapy may be delayed until 8-10 weeks after completion of that treatment. - Patients with tumours that involve surrounding structure such as the sacral bone or prostate should be discussed in a specialist MDT and if operable, after neoadjuvant therapy, should be referred to a specialist centre for exenterative surgery. 8. Service description – inoperable rectal cancer Ref. Appendix 6 Commissioning best practice pathway for early rectal cancer All service structure elements described for colon cancer pathways / rectal cancer pathways set out in sections 3-7 above, and relevant to the inoperable rectal cancer pathway should be followed. 9. Quality Requirements There are a number of criteria that should be met by any provider offering services for colorectal cancer patients ensuring high quality cost effective care and in accordance with NICE Guidance. 1.1. There should be an established weekly Multidisciplinary Team (MDT) meeting, where all patients have their treatment and care agreed, including any significant change to the treatment plan. MDTs will consider each patient for the potential of entry into clinical trials. 1.2. Providers will formally adopt the agreed best practice clinical pathway and the underlying clinical guidelines within their organisations’ clinical governance process. These pathways will represent the key elements of the service being commissioned and, together with guidelines and protocols, demonstrate the quality required. 1.3. All patients will have a named key worker to provide support at each stage of the pathway. 1.4. Each patient must have their holistic needs assessed at key stages of the pathway including survivorship and/or end of life care with formal care plans developed that are communicated to all teams/professionals involved in the patient’s care and shared with the patient (who will be free to share this with their carers/family). 1.5. The service must meet all current national quality standards (including ACPCBI), the recommendations set out in the cancer model of care, and the relevant NICE Improving Outcome Guidance. The service must be fully compliant with peer review measures. 7 of 16 10. Key Service Outcomes The key service outcome of this service specification is to “deliver high quality clinical services for patients with colorectal cancers, following the agreed best practice colorectal cancer pathway to ensure cancer survival rates in London are equal to or better than the best rates in Europe”. Any patient presenting with colorectal cancer will be placed on an agreed clinical pathway, to receive the most appropriate care for their condition. The implementation of these pathways will not only provide the best possible outcomes for the patients, but also allow NHS London to use resources effectively within the health economy. The key performance and quality indicators are listed below: Pathway Presentation Measure Percentage patients diagnosed with cancer who first present as an emergency Percentage patients seen within 2 weeks for urgent referral Number of patients diagnosed at each stage and proportion of all cancers. Percentage patients treated within 31 days (from diagnosis to treatment) Percentage patients treated within 62 days from urgent referral Number of new cases seen by MDT per annum Percentage patients entered into clinical trials Patient finds it easy to contact their CNS / keyworker Survival 30 days after surgery Percentage re-operation and readmission rates within 30 days Data source HES Reporting Quarterly Benchmark tbc CWT Quarterly tbc TCR Quarterly tbc CWT Quarterly tbc CWT Quarterly tbc Trust data Annual tbc NCRN Annual tbc NCPES Annual tbc HES & ONS HES Quarterly Annual tbc tbc Percentage of patients receiving radiotherapy delivered within 45 minutes of home Percentage of patients receiving IMRT Door to needle for neutropenic sepsis HES Annual tbc HES Quarterly tbc Trust data Quarterly tbc Chemotherapy Door to needle for neutropenic sepsis Trust data Quarterly tbc Follow up Percentage patients undergoing holistic needs assessment 1 year survival by stage Trust data Annual tbc TCR Annual tbc 5 year survival by stage 10 year survival by stage TCR TCR Annual Annual tbc tbc Percentage patients who died registered on the End of Life care CMC Annual tbc → Diagnostics → MDT → Surgery Radiotherapy Chemotherapy Survival Survival Survivorship 8 of 16 End of Life register. Percentage patients who die in their preferred place of death. Percentage patients and carers given clear and understandable written and verbal information at relevant stages of the pathway Proportion of units within the system complying with the requirements of the audit (Lung, Head and neck, OG and Colorectal) System CMC Annual tbc NCPES Annual tbc LUCADA, DAHNO, AUGIS and NBOCAP tbc Annual 11. Service structure – Informatics requirements Recording and collection of high quality data is essential to commissioners and providers. It allows the quality of care to be assessed and determines the improvements required. The providers within the Integrated Cancer Systems will provide agreed performance monitoring data against the metrics below on a quarterly basis. Where any elements of this deviate from the agreed plan, the service will provide a brief explanation accompanying the submission of the report. The provider shall ensure that standards of performance are routinely monitored and that remedial action is promptly taken where these standards are not attained. Providers, and their MDTs, will collect and submit data in line with both national and locally agreed requirements and as per the requirements of Section 29 and Schedule 5 of the NHS Contract. In 2012/13 ICSs will be required to ensure the data collection systems and protocols are in place to provide the following information to commissioners: Informing commissioners for new patients: o the date a patient is diagnosed with colorectal cancer o the stage at diagnosis o their NHS number or an agreed pseudonymised alternative. Informing commissioners for existing patients: o the date the stage of the cancer is diagnosed as having changed o the new stage. Informing commissioners for all patients: o the date an MDT ceases to have overall responsibility for the care of the patient o the reason for this (e.g. death/move away/patient chooses to stop having treatment etc). In addition: Providers within the ICS will complete the Cancer Registration Dataset (CRDS) for all patients. Providers within the ICS will submit the CRDS to the Thames Cancer Registry, commissioners and local cancer network quarterly seven weeks 9 of 16 after the quarter end. MDTs will be responsible for the completeness, quality and timeliness of data. 10 of 16 Appendix 1 Commissioning best practice pathway for early colon cancer 11 of 16 Appendix 2 Commissioning best practice pathway for late colon cancer 12 of 16 Appendix 3 Commissioning best practice pathway for colon cancer presented as an emergency 4. Enhanced recovery programme (partial) Admission to ICU 6. Stenting 1. Emergency via A&E 2. Emergency via GP 3. Resusitation and assessment 5. Partial or total laparoscopic colectomy 3a. CT scan- chest, abdomen, pelvis ± 3b. CEA / standard blood tests 7a. Colostomy (functioning / defunctioning) and ongoing stoma mgmt 8. Colorectal MDT: NS appointed / liver specialist input 9. Post-operative imaging 7b. Second surgery closure temporary stomas 13 of 16 join elective pathways Appendix 4 Commissioning best practice pathway for early rectal cancer 14 of 16 Appendix 5 Commissioning best practice pathway for late rectal cancer 15 of 16 Appendix 6 Commissioning best practice pathway for inoperable rectal cancer 16 of 16