Follow-up in oncology. Identify objectives, substantiate actions
27 March 2007
Health Council of the Netherlands. Follow-up in oncology. Identify objectives, substantiate actions. The Hague: Health Council of the Netherlands, 2007; publication no. 2007/10
The Minister of Health, Welfare and Sport has asked the Health Council whether it is possible to formulate an assessment framework that could be used to evaluate the practical value of a follow-up programme for patients who have undergone cancer treatment. This advisory report defines follow-up as that form of aftercare provided to patients on a programmatic basis. Further to the terms of reference for this report, the authors have confined themselves to a consideration of solid tumours in adults, as suggested by the minister.
Aftercare – and hence follow-up – has various objectives
Patients who have been treated for cancer with a view to bringing about a complete cure generally spend a long period under the doctor’s supervision in “aftercare”. The number of such patients will increase substantially during the next ten to twenty years. The primary objective of aftercare is concerned with the provision of information and the identification and treatment of the (often significant) effects of the disease itself or the therapy which the patient has undergone. Those effects can be physical, psychological and/or social. They can become manifest immediately, but may also occur many years later. Examples include lymphoedema in the arm, fibrosis in various organs, colostomy, chronic fatigue, sexual dysfunction, depression, problems at work, and the impairment of organ systems, even many years after the treatment itself. Aftercare can also be concerned with the early detection of new manifestations of cancer which are related to the treated cancer: relapse, metastases or new tumours. Here, the premise is that early detection will enable more effective treatment to be given than if patient and doctor were to wait for clinical symptoms to appear. Thirdly, aftercare is also important in terms of the evaluation of medical procedures with a view to improving the quality of medical care for patients, both now and in the future.
The term “aftercare” could suggest that there is always a clearly defined moment at which treatment ends and aftercare begins. It is now common for treatment to comprise various forms of therapy in combination: surgery, radiotherapy, chemotherapy and other pharmacological interventions. Each of these modalities may be subject to subsequent monitoring. It is therefore not uncommon for the aftercare of one therapy to overlap with the active implementation of another. Clearly, this makes it more difficult to substantiate the aftercare provided, but this is the reality of healthcare.
The majority of health complaints and problems which emerge immediately after treatment resolve themselves within a year. However, some persist for much longer. Even years later, it may be appropriate to link some new complaint to the earlier diagnosis of, and treatment for, cancer. In principle, the aftercare that can be provided at the patient’s request is therefore “not time-limited”. A patient should always be able to present his or her health complaints to the most appropriate physician.
Follow-up is programmatically provided aftercare
Aftercare often entails a programmatic set of services provided by healthcare and other staff. Depending on the type of tumour involved, there will be a set timetable of appointments, with the diagnostic procedures to be performed at each one established in advance. This programmatic approach is the main topic of this advisory report. It is referred to throughout as “follow-up”. The fundamental difference between aftercare and follow-up is not to be seen in terms of the objective, but in the organisation and the initiative. Nevertheless, it is clear that one of the objectives of aftercare – the early detection of new manifestations of cancer – can only be accomplished by means of a programmatic approach. Moreover, applying our definition of “follow-up”, it is expressly confined to the cancer-free period following the curative treatment.
The optimum form and duration of follow-up is unclear, and may well change in line with new developments. Moreover, it will vary according to the type of tumour concerned. Current clinical guidelines provide an indication of what is “usual”, based on knowledge and experience. However, they acknowledge that – in the case of the most commonly occurring tumours – hard scientific evidence to support these guidelines is far from complete.
When several specialists are involved in the follow-up process, they should make agreements with regard to which of them is to coordinate the overall programme. We note that such agreements are currently the exception rather than the rule.
The three objectives in closer detail
The identification of general physical and psychological complaints is recognised an extremely important component of current follow-up activities, but it is not undertaken in any uniform, systematic manner. Information, psychosocial support and the relevant interventions should form an integrated part of follow-up. However, the optimum form of psychosocial care in this context remains uncertain. Research in this area should be encouraged and prioritised. Similarly, the effectiveness of revalidation programmes (in the broadest sense of the term) should be more fully established. A small subgroup of patients will require referral to further expert assistance if their complaints seem likely to persist.
Aftercare and follow-up are concerned with providing appropriate care for the immediate adverse effects of the treatment. For the time being, the identification of complaints which develop at a (much) later date should clearly require the active involvement of the patient’s own general practitioner. This is dependent on the GP having the benefit of proper information and instructions from the specialist, and on these individuals reaching appropriate and structural agreements.
Early detection is gradually becoming the most important basis for follow-up. This can only be performed within a programmatic approach, but it should only be undertaken in cases where – according to scientific evidence - it is likely to prolong life to a significant degree or result in an improved quality of life. In the case of some tumours and treatments, we now know that early detection can provide such benefits even many years later. However, it is thought that in other cases early detection – at least in its current form – is not effective and can place unnecessary stress on the patient, while making undue claims on the valuable resources of the healthcare sector.
Follow-up offers an opportunity to evaluate the medical interventions and quality of care. However, explicit indicators are required, together with a systematic approach.
Assessment framework for a general follow-up programme
In practice, the various objectives of follow-up overlap each other. This report presents an assessment framework which will enable the effectiveness of these activities to be more clearly established. A number of questions have been formulated, each addressing the specific objectives separately. The scientific and other arguments which are relevant to answering these questions then become apparent. The answers to the questions produce separate scenarios for each objective. These scenarios vary in terms of content and timeframe. The combination of these scenarios forms a general programme of follow-up for a specific type of cancer. An annex to this report examines the practical usefulness of the assessment framework using two examples: breast cancer and colorectal cancer.
A “moment of systematic reconsideration”
In the vast majority of cases there will be an initial period in which all the various sub-scenarios are relevant. It is possible that the patient will still be undergoing treatment (or part of it) at this time. However, there comes a moment at which the sub-scenarios addressing the effects of the disease and its treatment no longer apply. In the longer term, only the early detection of new manifestations and the identification of late effects will remain (where this is considered useful). At this point, there should be a systematic reconsideration of the necessity, content and form of any further follow-up. The exact timing of this reconsideration will depend in part on the duration, nature and form of the treatment targeting the tumour itself. Based on clinical experience, the “reconsideration moment” is likely to be somewhat earlier when following a single operation (resulting in no disfigurement or loss of function) than when following a prolonged course of chemotherapy. With a view to psychosocial recovery, a period of one year would seem to be a reasonable starting point for the moment, unless there is a prolonged overlap of treatment and follow-up or, conversely, a short period of treatment with a definite result. The reconsideration moment must be decided according to the type of tumour involved.
Individual tailoring of programmes and a responsible conclusion
Needless to say, the follow-up programme must be modified as the patient’s situation demands. The ability to determine an appropriate course of action for each patient is an absolute precondition at the time of reconsideration. Agreements should be made with the patient about the further content of the programme and how it is to be organized. The remainder of the programme must then be brought to a responsible conclusion. This is of major significance to the patient, in more ways than one. Every investigation of new manifestations which could be connected to the previous diagnosis of cancer can cause considerable stress and anxiety, and will sometimes unnecessarily emphasize the role of “patient”. On the other hand, many patients welcome the security of having a “direct line” to expert assistance, and are greatly reassured by favourable test results. The lack of contact with a familiar and trusted health care provider can give rise to anxiety about the future. Due attention must therefore be devoted, both by the physician and the patient, to the psychological aspects of terminating the series of contact moments. When a follow-up programme is concluded (or curtailed to a significant degree), a number of explicit requirements concerning due care must be met. These should be established for each programme by means of a protocol. The main requirement is that proper information and instructions are issued to the patient, and agreements are made to ensure the availability of further assistance should there be any questions, complaints or symptoms having a possible connection with the cancer or its treatment. Full information about any potential late adverse effects of the treatment, and about any signs which should prompt the patient to consult a doctor, must be provided.
The aftercare plan: more than a follow-up programme
This advisory report recommends that all written information should be compiled following treatment to form an “aftercare plan”, copies of which will be issued to the patient, his or her general practitioner and any other relevant parties. This aftercare plan is more than merely the follow-up programme. As a bare minimum, it will contain information about the physical and psychological impact of the disease and its treatment, about the desirability and form of follow-up, about the “reconsideration moment” described above, and about other ongoing points for attention. Once the follow-up programme has been concluded, further information, instructions and agreements will be incorporated into the plan, covering potential late side-effects of the treatment, the signs which should prompt consultation with a doctor, and the agreements regarding coordination between care providers and their respective areas of responsibility. The purpose of this information is to render the patient confident enough to lead as near normal a life as possible following completion of the follow-up programme, while knowing that the best possible care is available if required. When devising an individual aftercare plan of this kind, a useful resource is the Cancer Survivorship Care Plan published by the American Institute of Medicine. Every plan should be discussed and agreed with the patient. It seems logical that the person who coordinates the follow-up should also be responsible for drawing up the aftercare plan.
Conclusions: requirements for a follow-up programme
Based on the foregoing, the Committee suggests that the following requirements should apply to all follow-up programmes:
1 The programme as a whole must be systematically substantiated, whereby the weight of the evidence and arguments other than the purely scientific should be made explicit, and all activities within the programme coupled to one or more of the objectives.
- Where possible, the programme should rely on evidence-based approaches. Where the follow-up programme is based largely or wholly on expert opinions, further research to establish the validity of those opinions should be encouraged.
- Psychological, social and moral motives for programmatic follow-up must be made explicit.
- Where scientific or other motives do not provide clear grounds on which choices can be made, organizational arguments may prove decisive. In such cases, the nature of such arguments must be clearly stated.
- Where follow-up is used solely to evaluate medical procedures or for the purposes of scientific research, the explicit consent of the patient must be obtained and the programme conducted within a systematic framework.
2 The programme will indicate a moment at which the necessity, content and form of further follow-up are to be systematically reviewed: the “reconsideration moment”. In many cases, this will be about one year after the commencement of the follow-up programme.
3 Early detection of new manifestations of cancer should only be included in the follow-up programme where there is sufficient scientific evidence that it can lead to a worthwhile intervention which is more effective when carried out in an early stage (rather than later, when actual health complaints develop).
4 Active surveillance to identify late effects of the treatment should only be undertaken where there is sufficient scientific evidence that this can lead to a worthwhile intervention which is more effective when carried out in an early stage (rather than later, when actual health complaints develop).
5 The provision of information and of psychosocial care must form an integrated part of the follow-up programme.
6 The programme should be imbedded by means of professional guidelines (with reference to the form(s) of cancer involved). The care providers who are to carry out the follow-up activities must be qualified and competent to do so.
7 It must be clear which professional is to coordinate the follow-up activities.
8 Explicit requirements apply to the care and conscientiousness with which the follow-up programme is concluded. These requirements include those covering the inclusion of all required information, instructions and agreements concerning ongoing points for attention in a written aftercare plan.
9 The standard form of all programmes should be subject to regular re-evaluation (at least once in every five years) against the latest scientific insights. It must then be adapted as necessary.
Professional organizations and guideline committees should assume responsibility for formulating follow-up programmes for the various types of tumour. In the interests of the quality and continuity of care, the healthcare providers involved should make agreements regarding communication (including adequate reporting procedures), coordination, continuity and complementarity.
Advisable that visible results be achieved within five years
The Committee considers it desirable that:
a After undergoing treatment for cancer, every patient is to be given an aftercare plan including information about the further physical and psychosocial effects of the disease and its treatment, about the desirability and form of the follow-up programme, and about the “reconsideration moment”. At the conclusion (or curtailment) of the follow-up programme stipulated by the protocol, the patient should receive further instructions. Agreements about ongoing points for attention should be made.
b Follow-up programmes are to be devised for all types of tumour, in keeping with the methodology set out in this advisory report.
The Committee advises the minister to charge the relevant professional organizations with the realization of these concrete results within the coming five years. It also recommends that this process should be encouraged with incentivisation wherever possible.
No progress without research
There is a significant requirement for more research (and for longer-term research) supporting evidence-based follow-up programmes, and into the late effects of the treatments in use. Accordingly, prioritisation and incentivisation of research efforts is required within the context of research programmes, along with better registration facilities and a structure for translating research results into clinical practice. If this is to be achieved, those in the field must place follow-up and the long-term evaluation of treatment high on its agenda.
Health Council of the Netherlands. Follow-up in oncology. Identify objectives, substantiate actions. The Hague: Health Council of the Netherlands, 2007; publication no. 2007/10. ISBN 978-90-5549-641-9