Papers

Popularity of less frequent follow up for breast cancer in randomised study: initial findings from the hotline study

^a Cancer Research Campaign Department of Medical Oncology, Charing Cross Hospital, London W6 8RF, ^b Department of Radiotherapy, Charing Cross Hospital, London W6 8RF

Correspondence to: Dr Epstein

	Abstract

Top Abstract Introduction Patients and methods Results Discussion References

Objective: To compare the experiences of patients with breast cancer who were conventionally monitored with those in whom routine follow up was restricted to the time of mammography.
Design: Randomisation to conventional schedule of clinic visits or to visits only after mammography. Both cohorts received identical mammography and were invited to telephone for immediate appointments if they detected symptoms.
Setting: Combined breast clinic, Chelsea and Westminster Hospital.
Subjects: 211 eligible outpatients with a history of breast cancer.
Main outcome measures: Acceptability of randomisation, interim use of telephone and general practitioner, satisfaction with allocation to follow up.
Results: Of 211 eligible patients, 196 (93%) opted for randomisation in the study. Of these, 55 were under 50 years, 78 were diagnosed fewer than five years before, 90 had stage T2-4 tumours, and 71 had involved axillary nodes. Patients who did not participate were more likely to be under 50 years, to be two to five years after diagnosis, and to have had aggressive primary disease. Twice as many patients in both groups expressed a preference for reducing rather than increasing follow up. No increased use of local practitioner services or telephone triage was apparent in the cohort randomised to less frequent follow up by specialists.
Conclusions: Reducing the frequency of routine follow up has so far proved popular among patients with breast cancer at standard risk in this cohort. A multicentre study is needed to determine the effectiveness and cost-effectiveness of routine follow up with respect to disease outcomes.

	Introduction

Top Abstract Introduction Patients and methods Results Discussion References

Most patients who relapse after treatment for primary breast cancer do so within the first five years of follow up.¹ As curable intramammary relapses are more sensitively detected by mammography than by clinical examination,² regular mammography after lumpectomy has now become accepted practice in most centres. Asymptomatic detection of disseminated disease is also achievable by using routine radiological or serologic testing, or both, but objective benefit from this approach has not been shown. Indeed, the only undisputed effect of intensive monitoring is that of diminished relapse free survival.³ It is therefore not surprising that many retrospective studies have cast doubts on the effectiveness of routine non-mammographic investigations or clinical follow up, or both, for breast cancer.^{4 5 6 7} Despite these doubts routine follow up continues to be the norm, with many physicians assuming that patients are reassured by frequent contact with their oncologist.⁸ This view is not universal, however, as evidenced by wide disparities in follow up practice on both sides of the Atlantic^{9 10 11}; disparities that have been attributed to defensive perceptions by physicians unsure as to the efficacy of treatment and monitoring.^{12 13} For these reasons many authorities have lately acknowledged the need for a prospective randomised study to determine the benefits of the tradition of routine follow up.^{14 15 16 17}

In this pilot study we compared the experience of a cohort who received conventional follow up with that of a similar cohort in whom review, in the absence of symptoms, was restricted to the time of mammography.

	Patients and methods

Top Abstract Introduction Patients and methods Results Discussion References

Participants–All eligible patients seen at the Chelsea and Westminster combined breast clinic over a 24 month period were offered randomisation. Eligibility criteria were a history of breast cancer proved by biopsy; lack of known recurrence of cancer; current lack of symptoms consistent with recurrence; no active management apart from adjuvant tamoxifen; home telephone; fluency in English; and informed consent. Details of disease stage for patients who declined participation were recorded anonymously to provide an internal control for recruitment bias. Primary treatment and staging details were obtained from information in medical records, the Charing Cross CTS computer system, correspondence with patients, and archives. Median follow up for the present analysis was 16 months.

Follow up and mammography scheduling–Table 1 presents the schedule for visits. No restrictions were placed on attendance at other hospital or local clinics. Patients older than 70 years and for whom over five years had passed since diagnosis were not routinely scheduled for mammography but continued outpatient review according to the same schedule shown in table 1. All patients were advised to examine their breasts each month and to request an immediate appointment if they felt a lump or developed any other symptom.

Telephone access and questionnaires–All patients were instructed to telephone immediately if they developed symptoms or had other concerns; in these circumstances an appointment to be seen within five working days was made. Records were kept concerning the content of all telephone calls from patients in the study. Questionnaires based on the Medical Research Council quality of life questionnaire were used and included additional questions relating to frequency of follow up in hospital and general practice, satisfaction with clinic visits, and the time and expense entailed in clinic attendance; these were sent to patients annually, beginning six months after study entry.

Protocol violation and termination–Documentation of progression of disease or second malignancy automatically terminated participation in the study (10 patients) as did any decision after randomisation by any patient to pursue an alternative schedule of appointments or mammograms to that specified in the protocol (three patients).

	Results

Top Abstract Introduction Patients and methods Results Discussion References

Patterns of patient recruitment–Age distribution, duration since diagnosis, and primary disease stage did not differ substantially between the cohorts (table 2). Fifteen eligible patients (7%) declined participation; this group was distinguished by a trend towards a higher stage of primary disease, younger age, and more recent diagnosis; other parameters were not appreciably different (table 3). We consider that the minor degree of selection bias suggested here does not confound the broad conclusions of this study.

Interval events
Telephone calls and visits to general practitioners–Twenty one telephone calls from patients without symptoms were received during this phase of the study: 11 in the conventional arm and eight in the mammogram only arm. Of note, eight of the 11 calls in the conventional arm related to queries about clinic appointments compared with only one such query in the mammogram only arm (table 4). Hence, the potential problems of a heavy workload of telephone counselling in the mammogram only cohort have so far failed to materialise, consistent with the experience of other clinical groups who have successfully used telephone advice lines.¹⁸ Forty six visits to general practitioners were recorded in the conventional cohort compared with 53 in the mammogram only group. Seven (15%) visits in the former group, however, were related to cancer problems compared with only four (7.5%) in the latter (table 4). Although these numbers are small, this finding suggests that less frequent specialist follow up of patients without symptoms may not necessarily translate into a heavier burden of care for local practitioners.

Response to clinic visits–A similar majority of respondents in both cohorts thought that their clinic visit was reassuring, perhaps more so than similar follow up with their general practitioner alone (table 5). This is consistent with the findings of similar studies,^{19 20} though some have suggested community follow up to be equally popular.²¹ Similar proportions of patients in both arms admitted a preference for either more or less frequent follow up visits, though in absolute terms more than twice as many favoured the latter (table 5).

Time and expense entailed in clinic visits–With respect to the inconvenience of attending the clinic as assessed by questionnaire, no substantial differences were apparent between the two groups. A minimum of four hours from door to door was required for clinic attendance in 73 patients (median three hours); 37 needed to take time off work and 80 were accompanied by another person (a quarter of whom needed to take time off work). No personal costs in attending clinics were incurred by 67, while 49 of the remainder incurred costs in excess of £10 and eight more than £50.

	Discussion

Top Abstract Introduction Patients and methods Results Discussion References

The present study is limited by its size and duration and does not justify publication of immature data concerning recurrence and quality of life. A study of survival outcomes would require several thousand patients and many years of follow up to establish the relative incidence of uncontrolled local recurrence, particularly late stage recurrence within the breast. The early phase of such a study would also need to focus on the possibility of more local or distant recurrences, or both, being detected in the "conventional" group, thus implying a shorter lead time (and, perhaps, more effective local treatment). Interim analysis of the present results indicates that no such trend has yet emerged; indeed, of the recurrences documented to date, all have been detected at interval (as opposed to scheduled) visits. We acknowledge, however, that these unpublished observations fall short of establishing the safety of less frequent follow up.

What does seem clear from the present study is that this cohort of patients with breast cancer was highly supportive of the option to pursue less frequent follow up and seemed willing to assume responsibility for seeking medical attention in the event of symptoms. These findings are consistent with those of other groups.²² Moreover, the data reveal surprisingly little hesitancy from subgroups one might have expected to be reluctant–that is, the young, the recently diagnosed, and those with more aggressive primary disease–notwithstanding that this profile was somewhat over-represented among the patients who did not participate.

The potential benefits of less intensive monitoring are clear. Clinicians are able to rationalise their practices and thus improve the efficiency of patient care; anxiety and inconvenience for patients without symptoms is minimised; outpatient clinic waiting time is reduced, increasing evaluation time for sick patients; nursing and reception staff are able to provide higher quality outpatient service by having fewer arrivals and room changes to deal with; the efficiency of general practitioner referral to hospital specialists improves; and healthcare purchasers reap the rewards of greater cost-effectiveness. Given this potentially attractive harvest, financial support for this pilot study was been surprisingly hard to find (table 6). None the less, we submit that these preliminary findings establish both the feasibility and desirability of a larger and more comprehensive national initiative to establish the value of routine follow up for cancer and other diseases.

	Acknowledgements

We thank E Woods for assistance with randomisation, C Coombes for support, and our patients for their kind and spirited cooperation.

Funding: TG is supported by the Medical Research Council and RE by the Cancer Research Campaign.

Conflict of interest: None.

	References

Top Abstract Introduction Patients and methods Results Discussion References

1. Early Breast Cancer Trialists' Collaborative Group. Systemic treatment of early breast cancer by hormonal, cytotoxic, or immune therapy. Lancet 1992;339:1-15, 71-85. [Medline]
2. Mellink W, Holland R, Hendriks J, Peeters P, Rutgers E, Van Daal W. The contribution of routine follow-up mammography to an early detection of asynchronous contralateral breast cancer. Cancer 1991;67:1844-8.
3. Coombes C, Powles TJ, Gazet J, Nash AG, Ford HT, McKinna A, et al. Assessment of biochemical tests to screen for metastases in patients with breast cancer. Lancet 1980;i:296-8.
4. Winchester DP, Sener SF, Khandekar JD, Oviedo MA, Cunningham MP, Caprini JA, et al. Symptomatology as an indicator of recurrent or metastatic breast cancer. Cancer 1979;43:956-60. [Medline]
5. Tomin R, Donegan WL. Screening for recurrent breast cancer–its effectiveness and prognostic value. J Clin Oncol 1987;5:62-7.
6. Stierer M, Rosen HR. Influence of early diagnosis on prognosis of recurrent breast cancer. Cancer 1989;64:1128-31.
7. Del Turco MR, Palli D, Cariddi A, Ciatto S, Pacini P, Distante V. Intensive diagnostic follow-up after treatment of primary breast cancer: a randomized trial. JAMA 1994;271:1593-7.
8. Wertheimer MD. Against minimalism in breast cancer follow-up. JAMA 1991;265:396-7.
9. Waghorn A, Thompson J, McKee M. Routine surgical follow up: do surgeons agree? BMJ 1995;311:1344-5.
10. Richert-Boe KE. Heterogeneity of cancer surveillance practices among medical oncologists in Washington and Oregon. Cancer 1995;75:2605-12. [Medline]
11. Maher EJ. Non-surgical management of early breast cancer in the United Kingdom: follow-up. Clin Oncol 1995;7:227-31.
12. Spratt JS, Spratt SW. Medical and legal implications of screening and follow-up procedures for breast cancer. Cancer 1990;66:1351-62. [Medline]
13. Simon MS, Stano M, Hussein M, Hoff M, Smith D. An analysis of the cost of clinical surveillance after primary therapy for women with early stage invasive breast cancer. Breast Cancer Res Treat 1996;37:39-47.
14. Dewar J. Follow up in breast cancer. BMJ 1995;310:685-6. [Free Full Text]
15. Loprinzi CL. It is now the age to define the appropriate follow-up of primary breast cancer patients. J Clin Oncol 1994;12:881-3.
16. Brada M. Is there a need to follow up cancer patients? Eur J Cancer 1995;31A:655-7.
17. Liberati A. Follow-up in breast cancer: a model case for controlled evaluation of complex interventions. Ann Oncol 1995;6:747-50.
18. Nagle JP, McMahon K, Barbour M, Allen D. Evaluation of the use and usefulness of telephone consultations in one general practice. Br J Gen Pract 1992;42:190-3. [Medline]
19. Glynn-Jones R, Chait I, Thomas S, Trotman I. Patients prefer hospital follow up for cancer (letter). BMJ 1995;311:1574-5.
20. Maher J, Bradburn J, Adewuyi-Dalton R. Follow up in breast cancer: patients prefer specialist follow up (letter). BMJ 1995;311:54. [Free Full Text]
21. Grunfeld E, Yudkin P, Adewuyl-Dalton R, Vessey MP, Mant D. Follow up in breast cancer: quality of life unaffected by general practice follow up (letter). BMJ 1995;311:54.
22. Emberton M. Outpatient follow up. Who benefits: doctors or patients? BMJ 1995;311:1315-6. [Free Full Text]

CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    StumbleUpon    Technorati    What's this?

This article has been cited by other articles:

• Grunfeld, E. (2006). Looking Beyond Survival: How Are We Looking at Survivorship?. JCO 24: 5166-5169 [Abstract] [Full text]  
• Khatcheressian, J. L., Wolff, A. C., Smith, T. J., Grunfeld, E., Muss, H. B., Vogel, V. G., Halberg, F., Somerfield, M. R., Davidson, N. E. (2006). American Society of Clinical Oncology 2006 Update of the Breast Cancer Follow-Up and Management Guidelines in the Adjuvant Setting. JCO 24: 5091-5097 [Abstract] [Full text]  
• Grunfeld, E., Levine, M. N., Julian, J. A., Coyle, D., Szechtman, B., Mirsky, D., Verma, S., Dent, S., Sawka, C., Pritchard, K. I., Ginsburg, D., Wood, M., Whelan, T. (2006). Randomized Trial of Long-Term Follow-Up for Early-Stage Breast Cancer: A Comparison of Family Physician Versus Specialist Care. JCO 24: 848-855 [Abstract] [Full text]  
• Khatcheressian, J. L., Smith, T. J. (2006). Randomized Trial of Long-Term Follow-Up for Early-Stage Breast Cancer: A Comparison of Family Physician Versus Specialist Care. JCO 24: 835-837 [Full text]  
• Mandelblatt, J., Armetta, C., Yabroff, K. R., Liang, W., Lawrence, W. (2004). Descriptive Review of the Literature on Breast Cancer Outcomes: 1990 Through 2000. J Natl Cancer Inst Monogr 2004: 8-44 [Abstract] [Full text]  
• Pascoe, S. W, Neal, R. D, Allgar, V. L, Selby, P. J, Wright, E P. (2004). Psychosocial care for cancer patients in primary care? Recognition of opportunities for cancer care. Fam Pract 21: 437-442 [Abstract] [Full text]  
• Kattlove, H., Winn, R. J. (2003). Ongoing Care of Patients After Primary Treatment for Their Cancer. CA Cancer J Clin 53: 172-196 [Abstract] [Full text]  
• Loprinzi, C. L., Hayes, D., Smith, T. (2003). Doc, Shouldn't We Be Getting Some Tests?. JCO 21: 108s-111 [Full text]  
• Bernhardt, B., Hayes, D., Loprinzi, C. L., Smith, T. J. (2000). Correspondence Re: ""Doc, Shouldn't We Be Getting Some Tests?"". JCO 18: 3739-3741 [Full text]  
• Loprinzi, C. L., Hayes, D., Smith, T. (2000). Doc, Shouldn't We Be Getting Some Tests?. JCO 18: 2345-2348 [Full text]  
• Temple, L. K.F., Wang, E. E.L., McLeod, R. S. (1999). Preventive health care, 1999 update: 3. Follow-up after breast cancer. CMAJ 161: 1001-1008 [Abstract] [Full text]  
• (1997). LESS FREQUENT FOLLOW-UP IN BREAST CANCER: OK WITH PATIENTS. JWatch General 1997: 4-4 [Full text]