Annals of Oncology

Annals of Oncology Advance Access published online on May 24, 2007
Annals of Oncology, doi:10.1093/annonc/mdm193

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© 2007 European Society for Medical Oncology

Questioning specialists' attitudes to breast cancer follow-up in primary care

P Donnelly^1,*, L Hiller², S Bathers³, S Bowden³ and R Coleman⁴

¹ Breast Care Directorate, South Devon Healthcare NHS Foundation Trust, Torquay
² Warwick Clinical Trials Unit, Health Sciences Research Institute, Warwick Medical School, Coventry
³ Division of Cancer Studies, UK Clinical Trials Unit, University of Birmingham, Birmingham
⁴ Academic Unit of Clinical Oncology, Weston Park Hospital, Sheffield, UK

^* Correspondence to: Dr P. Donnelly, Breast Care Directorate, South Devon Healthcare NHS Foundation Trust, Lawes Bridge, Torquay TQ2 7AA, UK. Tel: +44-1803-655039; Fax: +44-1803-655068; E-mail: peter.donnelly{at}nhs.net

	Abstract

Top Abstract introduction methods statistical methods results discussion Appendix 1. Questionnaire Acknowledgements References

 
Background: National Institute for Clinical Excellence (NICE) guidelines recommend discharging asymptomatic breast care patients 3 years after diagnosis. A role for General Practitioners (GPs) and breast care nurses is proposed, together with skills training, but it remains unclear for how long breast cancer patients should be followed up, what tests should be done, and who should be conducting the follow-up. We therefore surveyed Breast Cancer Specialists.

Design: A 20-point questionnaire was sent to 562 Specialists registered in the Cancer Research Clinical Trials Unit database, with questions on case-load, perceptions of follow-up, local policy and opinions on greater primary care involvement.

Results: The most commonly acknowledged purpose of follow-up was detection of treatment-related morbidity. Eighty four percent of respondents adhered to a locally developed protocol with only 9% conforming to NICE guidelines. The median follow-up was 5 years. Significant factors predicting delayed discharge were younger age (P 0.0001); poorer Nottingham Prognostic Index (P = 0.003); treatment factors (P = 0.002); and patient risk factors (P = 0.003). Centres with higher case-loads (>200/year) were more likely to discharge earlier. Reduced workload was perceived as the main benefit of discharge, while lack of GP oncological experience and loss of outcome data were concerns.

Conclusions: Specialists favour a risk adjusted discharge strategy and increased oncology infrastructure in primary care.

breast, cancer, follow-up, primary care, questionnaire, specialists

	introduction

Top Abstract introduction methods statistical methods results discussion Appendix 1. Questionnaire Acknowledgements References

 
The value of clinical follow-up for breast cancer in hospitals (secondary care) has been questioned in several studies [1–3] on the basis that clinics are already heavily overbooked so that follow-up is cursory and recurrence, if it occurs, is most commonly outside of a review visit. Current National Institute for Clinical Excellence (NICE) guidelines [4] (paraphrased following) reflect this view.

• Networks should agree:

  the period of time after which patients will be released from routine follow-up, this should not be normally >3 years except for women in clinical trials.
  

  evidence-based policy on the frequency of mammography for women who have been treated for breast cancer.
  

  General practitioners (GPs) should:
  

  take responsibility for looking after women on long-term treatment with tamoxifen or other hormone-modifying drugs and for stopping such treatment after 5 years. They will need information on new arrangements and may need to access training in relevant aspects of breast cancer.
  

  utilise an open access policy to enable them or other health care professionals to refer patients back to the breast care team without delay.
  

  At the end of primary treatment, the patient and specialist should agree on a written care plan.
  

  
  

This devolution is set against a background concerning optimum long-term management of hormone therapy and new opportunities for GPs to extend their role under a new contract [5, 6]. It remains unclear for how long breast cancer patients should be followed up after initial treatment, what tests should be done and who should be conducting the follow-up. We therefore surveyed breast cancer specialists.

	methods

Top Abstract introduction methods statistical methods results discussion Appendix 1. Questionnaire Acknowledgements References

 
A structured questionnaire (Appendix 1) was proposed and developed >12 months at the request of the National Cancer Research Institute Breast Clinical Studies Group (BCSG) to establish current clinical practice in secondary care with regard to breast cancer follow-up and compliance with NICE guidelines [4]. The four themes of the questionnaire (i) specialist demographics and case-load, (ii) current practice, (iii) current philosophies and (iv) future directions were agreed with the membership. The initial questionnaire, which was substantially longer than the final draft and included several illustrative scenarios, was reviewed by members of the BCSG and the Primary Care Clinical Studies Development Group including lay membership. The revised and condensed final draft was reviewed by the attending membership of BCSG and a circulation strategy and support costs were agreed at an annual meeting. The strategy aimed to encourage a strong response to a detailed survey from those active specialists motivated to working within the Breast National Cancer Plan. The distribution was anonymous and supported by the Cancer Research UK Clinical Trials Unit (CRCTU) in Birmingham.

A 20-point questionnaire was sent to 562 specialists registered in the CRCTU database comprising 239 surgeons (42%), 205 clinical oncologists (36%), 77 medical oncologists (14%), 31 oncologists of unknown specialty (6%) and 10 general medical consultants (2%). The questions related to six areas are as follows: (i) details of respondents with respect to speciality case-load and location (metropolitan or district); (ii) specialists' perceptions of the purpose of follow-up; (iii) local organisation of follow-up with respect to leadership compliance with NICE guidelines and routine imaging protocols; (iv) local policy for tailoring discharge protocols in relation to potential risk factors. Assuming current local levels of support in primary care, specialists were asked to indicate their preferred duration of hospital-based follow-up in years for asymptomatic patients treated for invasive cancers in which surgery was optimal—i.e. all margins clear and lymph node staging adequate for the Nottingham Prognostic Index (NPI). Mammography was provided every 1–2 years with postal results from secondary care. All patients who became symptomatic were assumed to have access to a secondary care assessment clinic within 2 weeks of request; (v) free text comments were sought regarding potential benefits and disadvantages from greater primary care involvement together with preferences for the best model of care and (vi) opinions were sought regarding trial participation and the opportunities for delegating cancer clinical research from secondary to primary care.

	statistical methods

Top Abstract introduction methods statistical methods results discussion Appendix 1. Questionnaire Acknowledgements References

 
Frequencies and percentages were used to display responses to individual questions. Friedman's Two-Way analysis of variance by ranks tests were used to assess differences in preferred hospital-based follow-up duration between known patient risk factors. Medians, inter-quartile ranges and 90% confidence intervals of the follow-up durations for each risk factor were graphically displayed.

	results

Top Abstract introduction methods statistical methods results discussion Appendix 1. Questionnaire Acknowledgements References

 
respondents
Two hundred and fifty-six replies (46%) were received from a single mailing of the questionnaire. Respondents comprised 128 surgeons (50%), 93 clinical oncologists (36%), 32 medical oncologists (13%) and three radiologists (1%). The majority of responders were District Hospital based (54%) with a further 42% from Metropolitan Teaching Hospitals. With regard to activity, 38% of responders worked at units treating <200 new breast cancer cases per year, 48% 201–500 new cases and 13% >500 cases (1% non-response).

purpose of follow-up
Ten factors relating to breast cancer follow-up were listed and respondents were asked to indicate their level of agreement regarding their relative importance to follow-up. Ranked in order of the most frequent response for ‘strongly agree’ and ‘agree’, Figure 1 shows detection of treatment-related sequelae as being considered the major reason for specialist follow-up, with recognition of new ipsi- or contralateral abnormalities, psychological morbidity and recurrence as strong priorities. Organisation of surveillance imaging was considered less important.

View larger version (23K): [in this window] [in a new window] [Download PowerPoint slide]   Figure 1. What is the purpose of follow-up?

 
organisation of follow-up
When asked which lead clinician took charge of follow-up, 60% of respondents indicated the surgeon, while for 31% the role varied according to disease stage or circumstance (Table 1). Asked if there was a protocol for managing follow-up of women with early breast cancer, 84% confirmed that there was, but only 9% conformed to NICE guidelines. The remainder had a locally developed protocol. Forty-five respondents (18%) stated that they offered patients a choice in follow-up protocol of whom only 9% routinely gave patients a written plan.

View this table: [in this window] [in a new window]   Table 1. Organisation of follow-up

 
With regard to follow-up investigations in asymptomatic patients, >80% of respondents continued history and examination up to 5 years after diagnosis. However, 90% of respondents related never routinely undertaking chest X-rays, liver ultrasounds, bone scans, blood biochemistries or tumour markers.

Asked about imaging protocol for invasive disease, 67% arranged mammography annually, 9% every 18 months, 18% two yearly and 3% three yearly. For non-invasive disease, the figures were comparable, 62% annually, 10% at 18 months, 19% two yearly and 2% three yearly. Results of imaging were forwarded to the patients either by the surgeons in 73% of cases, by the radiologists in 11% of cases, or by oncologists in 6% of cases.

tailored discharge protocols
The preferred median follow-up overall was 5 years, also being 5 years for each and every patient, tumour and treatment factor, although some respondents recorded discharging as early as 1 year after diagnosis (5% less than 1 year in certain situations), while some retained patients beyond 10 years. Figure 2 shows the average recorded follow-up durations split by patient, tumour and treatment factors. Discharge at 3 years was more frequently arranged for those patients considered at low risk. Significant factors predicting delayed discharge were younger age (P < 0·0001), poorer NPI (P = 0·0003), treatment factors (P = 0·002) and patient risk factors (P = 0·003). Another factor contributing to delayed discharge which did not achieve significance overall was breast conservation surgery. The results were further analysed in relation to the type of contributing hospital. Metropolitan Teaching Hospital specialists appeared to regularly provide longer follow-up than District Hospital staff for patients with high treatment risk factors and specifically for patients with breast cancer family history, breast conservation surgery and patients with high social deprivation or oestrogen receptor (ER) negative and/or lobular tumours. The differences in practice were more striking when hospitals serving >200 breast cancer patients were compared with those treating fewer patients (Figure 3A and B).

View larger version (19K): [in this window] [in a new window] [Download PowerPoint slide]   Figure 2. Inter-quartile-range and 90% confidence intervals of preferred hospital follow-up duration.

 

View larger version (20K): [in this window] [in a new window] [Download PowerPoint slide]   Figure 3. (A) Inter-quartile-range and 90% confidence intervals of preferred hospital follow-up duration, by number of breast cancers treated a year by the unit (200 cases per year). (B)Inter-quartile-range and 90% confidence intervals of preferred hospital follow-up duration, by number of breast cancers treated a year by the unit (>200 cases per year).

 
primary care contribution to follow-up
Respondents were asked to comment on their perception of the benefits of discharge to primary care. The overwhelming response (n = 133, 70%) was ‘reduced clinic workload’. Asked what the main disadvantages were, the two most frequent responses were ‘lack of GP experience or training in oncology’ (n = 79) and ‘loss of patient outcome data’ (n = 42). With regard to changes in primary care infrastructure, specialists felt it would make them more likely to adopt earlier discharge. Responses were more variable with the three most frequent comments being ‘increased GP education and training’ (n = 57), ‘development of shared protocols’ (n = 22) and ‘recruitment of Primary Care Trust-based oncology nurses’ (n = 20).

Asked if GPs were aware that their patients were being discussed at multidisciplinary meetings, 84% responded positively although only 2% of these encouraged GPs to attend the meetings or participate through tele- or videoconferencing.

With regard to the options available for arranging monitoring after secondary discharge, the preferred options were patient-driven telephone calls to hospital breast care nurses (43%) and patients seen annually by GPs, plus additional as required access (43%). Less favoured options were patients seen annually by community nurses and additional as required access (13%) or patients telephoned annually by community nurses and as required (6%). Twenty-eight per cent of respondents considered all of the above would be appropriate and should be determined by patient choice.

Asked who was best placed to determine the balance between frequency of surveillance tests to determine recurrence and the patient's anxiety generated by the uncertainty of outcome, the responses were as follows—all in partnership 56%, hospital specialist 28%, patient 7% and GP 2%.

trial participation in secondary and primary care
Ninety-six per cent of respondents actively recruited patients to clinical trials. The majority of specialists referred 20% or more of their eligible patients to trials, with a quarter of all responders referring >50%. Asked what aspects of trial participation precluded early discharge to primary care, key factors were seen as knowledge, skills, access to examination and agreement from trial sponsors (Figure 4).

View larger version (20K): [in this window] [in a new window] [Download PowerPoint slide]   Figure 4. What aspects are lacking in trial participation that preclude early discharge to primary care.

 
Sixty-three per cent of respondents agreed in principle to support a training programme for GPs with special interest or community nursing staff to enable trials to be supervised in primary care. Fifty-nine per cent recorded that they would support greater involvement of primary care staff in trial development and 75% supported primary care recruitment to trials of patients previously discharged from secondary care. Two-thirds of respondents agreed that there should be a national standard and funding for the training of nursing staff to arrange clinical trials in the community.

	discussion

Top Abstract introduction methods statistical methods results discussion Appendix 1. Questionnaire Acknowledgements References

 
While there is a considerable body of research testing the views of patients and GPs regarding the feasibility of discharge to primary care [1–3], there has been relatively little evaluation of specialist opinion regarding the rationale and selection criteria for follow-up in a population where conservation surgery is predominant [7–12]. The most recent survey of surgeons, radiation oncologists and medical oncologists serving the Ottawa Regional Cancer Centre [13] obtained a 44% response rate and demonstrated no clear consensus on the purpose of follow-up with the potential to save costs through adoption of less interventionalist programmes. The present study of 256 respondents from the CRCTU trial database had a comparable 46% response rate from a single mail shot, with equal representation from surgeons and oncologists known to have a special interest in breast care. This balance of respondents has not been previously achieved and closely reflects the specialist disciplines of the target population. Accepting limitations posed by the response, most clinicians were involved in the care of >100 new breast cancers per year and therefore the views expressed in the survey would be regarded as being that of mainstream clinical practice. The preliminary results of the survey were sought by the Secretary of the Association of Breast Surgery @ British Association of Surgical Oncology. The Committee found the survey so comprehensive that they abandoned plans for their own survey and have used the findings to help formulate their new guidelines [14].

This is the first comprehensive assessment of specialist views on the purpose of follow-up and demonstrates that the most important consideration was treatment-related morbidity. This is not surprising, given the increased concern regarding the long-term adverse events (e.g. fracture) associated with aromatase inhibitor treatment. It is perhaps better recognised that other aspects of care currently carried out in hospital (e.g. organisation of imaging, psychological support) can be provided equally as well in a primary care setting.

While NICE guidance has strongly recommended follow-up for no longer than 3 years after treatment [4], the evidence that this time course is safe or acceptable to specialists is not established. The present study shows that the majority of clinics are in breach of guidelines, choosing to discharge at five or more years after treatment. There appears to be a widespread concern regarding the level of oncology knowledge among GPs and their ability to develop and use follow-up protocols pertinent to higher risk patients. Many published series on discharge to primary care relate to an era when mastectomy was more common and adjuvant treatment exclusively used tamoxifen [1–3, 7–13]. In the last decade, rising levels of conservation surgery (for which recurrence occurs at a rate of 1% per annum) and increased use of aromatase inhibitors mean that patients are less suitable for a deregulated model of community care.

Breast cancer was one of the first disciplines to demonstrate the redundancy of complex staging investigations [15] and the present survey confirms that over the last decade there has been a widespread acceptance that specialist follow-up focuses primarily on clinical and mammographic examination. Although disputed [16], the imaging protocol was consistent for both invasive and non-invasive disease with annual examination being utilised by almost two-thirds of surgeons and oncologists. Recent reports have identified a survival advantage from more frequent surveillance mammography [17]. If this protocol of radiological examination was linked to a concurrent enquiry of patient well-being, it could provide a simple and consistent method of tracking patient outcomes. A recent randomised study from Canada [18] showed the practicality of discharge to primary care 1 year after diagnosis. The GPs were working in a private system with high uptake of detailed clinical guidance including annual mammography, which may be difficult to replicate in the National Health Service.

In the present study, <5% of specialists would be prepared to discharge before 1 year regardless of their patients being asymptomatic with early access to secondary care. The majority preferred to risk stratify their patients for early or delayed discharge. While disease stage or severity, as represented by NPI, is understandable and is acknowledged in previous surveys, the present study for the first time identified younger age (<50 years), family history, treatment-related morbidity and ongoing hormone therapy as factors necessitating review for 10 or more years after diagnosis. Previous conservation rather than mastectomy was considered by many as an independent factor for which prolonged hospital follow-up was necessary. While this did not reach significance, overall this factor was (among other variables) considered important for long-term follow-up for those hospitals serving a population of 200 or less cases per year. The skills necessary to recognise a recurrent nodule on a flat mastectomy scar cannot realistically be equated to those needed to evaluate a progressively thickened operative scar area in a conserved breast wound. For specialists serving smaller populations, almost every variable from social deprivation to ER negativity was sufficient to recommend hospital follow-up beyond 5 years.

The majority of specialists indicated that GPs were aware that their patients were being discussed at Multidisciplinary Teams at which decisions regarding follow-up were being made, but there was little evidence of collaboration in shaping a discharge plan. While international multicentre studies have demonstrated the value of tele- or videoconferencing as a means of encouraging GP involvement in cancer care [19, 20], only 2% of respondents in the UK utilised this modality as a means of overcoming problems of distance or access. Patient initiated follow-up has been shown to be feasible [21], but the preferred point of contact for clinical review was the breast care nurse or the GP, with strong acknowledgement that a flexible scheme driven by patient choice and adjusted for social and geographic variables [22] was most appropriate.

It is a concern that breast cancer follow-up is becoming so devalued and deregulated that it puts the National Cancer Plan under threat by providing neither the psychological support that patients need nor the reliable data on which to base treatment plans which ensure low mortality and prolonged disease-free survival. A flexible programme that both encourages patient choice and develops primary care cancer infrastructure is urgently needed. This may take the form of an education package with opportunity for MDT participation for those GPs prepared to develop a special interest within their group practice [6, 23, 24] or to develop and resource community-based research nurses capable of supervising adjuvant drug trials, while ensuring that compliance with imaging protocols [25] including the monitoring of bone health for the maintenance of existing databases. A ‘National follow-up audit’ could provide a means of ensuring that the wide variety of ‘locally agreed models’ of community-based care actually deliver consistent high quality care as envisaged by NICE, while allowing the savings from reduced hospital visits to be passed on to patients through greater access to novel adjuvant cancer drugs [26, 27].

	Appendix 1. Questionnaire

Top Abstract introduction methods statistical methods results discussion Appendix 1. Questionnaire Acknowledgements References

 

1. What is your discipline?

   Surgeon Medical Oncologist Clinical Oncologist Other please specify
   

   
   
2. Is your unit?

   Metropolitan Teaching District General Rural Community Other please specify
   

   
   
3. How many breast cancers does your unit treat per year?

   0–50 51–100 101–200 201–500 500+
   

   
   
4. How many breast cancers do you treat personally each year?

   Less than 25 25–50 51–100 101–200 201–300 300+
   

   
   
5. Do you recruit patients to clinical trials?

   Yes No
   

   
   
6. Percentage of eligible women referred to trials?
   
7. Is there a protocol for managing follow-up of women with early breast cancer?

   Yes a locally developed protocol (Please attach copy if possible)
   

   Yes follow NICE guidelines No
   

   
   
8. Who is the lead clinician who takes primary charge of follow-up?

   a Breast Surgeon
   

   b Medical Oncologist
   

   c Clinical Oncologist
   

   d General Practitioner
   

   e Varies according to an agreed protocol between care specialists
   

   f Varies according to disease stage
   

   g Varies no agreed protocol
   

   h All care specialists independently follow-up patients
   

   
   
9. Are your General Practitioners made aware that their patients are being discussed at MDT?

   a Yes No
   

   or b encouraged to attend MDTs when their patients are being discussed?
   

   No Yes, in person via teleconference or video conference Other please specify
   

   
   
10. Are your patients offered a choice in follow-up protocol

    a Yes No Other specify
    

    b Are your patients given a written plan?
    

    Always Mostly Rarely
    

    
    
11. Which of the following best describes your imaging policy?
    

    a In situ Cancer Mammography annually (DCIS) every 18 months every 2 years every 3 years after—yrs post diagnosis b Invasive Cancer Mammography annually every 18 months every 2 years every 3 years after—yrs post post diagnosis c The results of surveillance imaging are forwarded to the patient by the Radiologist Surgeon Oncologist Other specify

    
    

12. How often are the following additional examinations routinely undertaken during follow up post-invasive breast cancer surgery in asymptomatic patients?
    

    Examination Time post surgery follow-up duration in (years) Never Circle choice of follow-up a History and Exam <1 1 2 3 4 5 6 7 8 9 10 11 or > b Liver ultra sound <1 1 2 3 4 5 6 7 8 9 10 11 or > c Chest X-ray <1 1 2 3 4 5 6 7 8 9 10 11 or > d Bone Scan <1 1 2 3 4 5 6 7 8 9 10 11 or > e Blood Count & Biochemistry <1 1 2 3 4 5 6 7 8 9 10 11 or > f Tumour Markers <1 1 2 3 4 5 6 7 8 9 10 11 or > g Other please specify <1 1 2 3 4 5 6 7 8 9 10 11 or >

    
    

13. What is the Purpose of Follow-Up?
    

    Please circle Strongly Agree Agree Neither Agree or Disagree Disagree Strongly disagree a Detect Recurrence or Metastasis and Treat (Clinical, Imaging) 1 2 3 4 5 b Detect Treatment Sequelae and Treat (e.g. Lymphoedema, Prostheses, Arm Pain) 1 2 3 4 5 c Detect Psychological Morbidity and Treat (Anxiety, Depression) 1 2 3 4 5 d Provide Access to Aesthetic Surgery (e.g. Reconstructive) 1 2 3 4 5 e Organise Surveillance Mammography 1 2 3 4 5 f Detect new Abnormality in Ipsi- or Contra Lateral Breast 1 2 3 4 5 g Assess Suitability of Secondary Adjuvant Therapy 1 2 3 4 5 h Assess Family History Risk and Organise Preventative Strategies 1 2 3 4 5 i Assess Quality of Life and Social Integration 1 2 3 4 5 j Ensure current status (i.e. alive, well and symptom free) is reliably known for actuarial survival plots 1 2 3 4 5 k Other please specify 1 2 3 4 5

    
    

14. What do you see as the benefits of discharge to primary care?

    Specify
    

    
    
15. What do you see as the main disadvantages of discharge to primary care?

    Specify
    

    
    
16. What changes in primary Care infrastructure would make you more likely to adopt earlier discharge?

    Specify
    

    
    
17. How would you tailor your discharge protocol (assuming current local levels of support in primary care) for asymptomatic patients treated for invasive cancers in which surgery was optimal—i.e. all margins clear and lymph node staging adequate for NPI. Mamography every 1–2 years and postal results from secondary care. All patients who become symptomatic are assumed to have access to secondary care assessment clinic within two weeks of request.

    Preferred Hospital Based Follow-up Duration in (years)
    

    
    

    Circle choice of follow-up a) Age <50 <1 1 2 3 4 5 6 7 8 9 10 11 or > 50–70 <1 1 2 3 4 5 6 7 8 9 10 11 or > >70 <1 1 2 3 4 5 6 7 8 9 10 11 or > b) Type of Surgery Conservation + Axilla <1 1 2 3 4 5 6 7 8 9 10 11 or > Mastectomy (MST) + Axilla <1 1 2 3 4 5 6 7 8 9 10 11 or > MST + Axillia + Reconstructed <1 1 2 3 4 5 6 7 8 9 10 11 or > c) Type of Pathology Ductal <1 1 2 3 4 5 6 7 8 9 10 11 or > Lobular <1 1 2 3 4 5 6 7 8 9 10 11 or > NPI Good <1 1 2 3 4 5 6 7 8 9 10 11 or > Mod <1 1 2 3 4 5 6 7 8 9 10 11 or > Poor <1 1 2 3 4 5 6 7 8 9 10 11 or > ER Positive <1 1 2 3 4 5 6 7 8 9 10 11 or > Negative <1 1 2 3 4 5 6 7 8 9 10 11 or > d) Environmental Risk Factors High social deprivation <1 1 2 3 4 5 6 7 8 9 10 11 or > Low social deprivation <1 1 2 3 4 5 6 7 8 9 10 11 or > Urban <1 1 2 3 4 5 6 7 8 9 10 11 or > Rural <1 1 2 3 4 5 6 7 8 9 10 11 or > e) Patient Risk Factors Thrombosis <1 1 2 3 4 5 6 7 8 9 10 11 or > Endometrial Cancer <1 1 2 3 4 5 6 7 8 9 10 11 or > Breast Cancer family history <1 1 2 3 4 5 6 7 8 9 10 11 or > HRT for > 5 yr post menopause <1 1 2 3 4 5 6 7 8 9 10 11 or > Osteoporosis <1 1 2 3 4 5 6 7 8 9 10 11 or > f) Treatment Factors Completed Chemotherapy <1 1 2 3 4 5 6 7 8 9 10 11 or > Completed Radiotherapy <1 1 2 3 4 5 6 7 8 9 10 11 or > Ongoing Hormone Therapy <1 1 2 3 4 5 6 7 8 9 10 11 or > Failure to complete any aspect of recommended therapy <1 1 2 3 4 5 6 7 8 9 10 11 or > Treatment-related morbidity (e.g. lymphoedema, poor cosmesis, shoulder stiffness or paraesthesia) <1 1 2 3 4 5 6 7 8 9 10 11 or >

    
    

    
    
18. *How should patients discharged from regular clinic review in secondary care be monitored?
    

    Yes No a) Patient driven telephone call to hospital BCN b) Patient seen annually by GP and PRN c) Patients seen annually by community nurse and PRN d) Patients telephoned annually by community nurse and PRN e) All of the above and determined by patient choice

    * (assuming 1–2 yearly mammography).
    

    
    
19. What aspect of trial participation precludes early discharge to primary care?

    a. Lack of agreement from trial sponsors
    

    b. Lack of access to required examinations
    

    c. Lack of primary care involvement at initial follow-up protocol
    

    d. Lack of community infrastructure
    

    e. Lack of knowledge and skills to complete protocols
    

    f. Lack of satisfactory supervision of ethical issues
    

    g. Lack of community pharmacy support
    

    h. Lack of community psychological support
    

    Other specify
    

    
    
20. What could be done to facilitate trial participation in Primary Care?

    a. Would you support a training programme to enable GPs and community nursing staff to supervise trials in primary care? Yes No
    

    b. Would you support greater involvement of suitably trained primary care staff in the development of Clinical Trial Projects? Yes No
    

    c. Would you support primary care staff initiating and recruiting to clinical trials breast cancer patients previously discharged from secondary care? Yes No
    

    d. There is a balance between the frequency of surveillance tests to determine recurrence (i.e. clinical exam, tumour marker tests, imaging) and the patient anxiety generated by the uncertainty of outcome. Who is best placed to determine the balance?
    

    The hospital specialist The GP The patient All in partnership
    

    e. Should there be a national standard and funding for the training of nursing staff to manage clinical trials in the community? Yes No
    

    
    

Thank you for completing this questionnaire

Please return in the enclosed envelope to:

Follow-up Questionnaire CRUK Clinical Trial Unit Institute for Cancer Studies University of Birmingham B15 2TT

	Acknowledgements

Top Abstract introduction methods statistical methods results discussion Appendix 1. Questionnaire Acknowledgements References

 
The authors are most grateful to members of the National Cancer Research Institute Breast and Primary Care Clinical Studies Groups, including consumer representatives who provided critical feedback on the questionnaire and its analysis. Many thanks for interest and support from Surgeons and Oncologists who responded to the questionnaire. This work was sponsored by support from South Devon Healthcare Charitable Trust Funds and the National Cancer Research Network.

Received for publication March 1, 2007. Revision received April 2, 2007. Accepted for publication April 11, 2007.

	References

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