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A randomized study of telephone contact following completion of radiotherapy
Clinical Oncology(1994) 6:242-244 © 1994The Royal Collegeof Radiologists
Clinical Oncology
Original Article A Randomized Study of Telephone Contact Following Completion of Radiotherapy A. J. Munro, T. Shaw, L. Clarke, L. Becker and S. Greenwood Department of Radiotherapy, St Bartholomew's Hospital, London, UK
Abstract. The hypothesis tested was that routine contact by telephone might significantly improve the adequacy of support for patients during the potentially stressful period between completing radiotherapy and the first follow-up visit. The study was a randomized controlled trial in which 100 patients were allocated either to telephone contact (intervention arm) or usual care (control arm). Adequacy of support was assessed by a questionnaire administered at the first follow-up visit. There were no significant differences in the perceived adequacy of support between the two arms. Of the 72 patients who completed questionnaires, 76% of those in the intervention arm versus 61% in the control arm rated their support after radiotherapy as 'extremely adequate'. The 95% confidence interval (CI) for this 15% rate difference was - 6 +36. Analysis by intention to treat showed a rate difference of only 4% (95% CI - 1 7 - + 2 5 ) in favour of intervention. We conclude that, given the limited resources currently available, it is not possible to justify a policy of routine contact by telephone for all patients completing radiotherapy. Keywords: Patient support; Psychosocial oncology; Radiotherapy; Telephone contact
INTRODUCTION There is anecdotal evidence to suggest that patients with cancer find the period immediately after the completion of intensive treatment to be particularly stressful [1]. The problem may arise, in part, from the withdrawal of routine daily contact with the hospital. Patients sometimes feel, between completing treatment and the first follow-up, as if they are in limbo. Irrational fears may arise, such as, 'They are not seeing me at the hospital any more because treatment has failed and there is nothing more they can do.' It is possible that adverse reactions to the withCorrespondence and offprint requests to: A. J. Munro, Consultant Radiotherapist, Department of Radiotherapy, St Bartholomew's Hospital, West Smithfield, London EC1A 7BE, UK.
drawal of daily contact with the hospital might be mitigated by routine telephone calls to patients during the interval between the end of treatment and first follow-up visit. We performed a randomized controlled study to investigate this hypothesis.
PATIENTS AND METHODS Consecutive unselected outpatients attending for radiotherapy under the care of one consultant were considered for entry into the study. The following groups of patients were ineligible: patients who did not understand English; those who did not have a telephone; patients with HIV related malignancies; those treated with less than five fractions of radiotherapy; and hospital inpatients. Eligible patients were randomized between usual care during and after treatment, and usual care plus telephone contact. Telephone contact comprised telephone calls to the patient on days 4, 8, 14 and 18 after completing radiotherapy. The telephone calls were made by a member of staff, radiographer, nurse, or doctor who was known to the patient. The calls were semistructured, the questions to be asked being: 'How are you feeling?' 'Are you having any problems?' 'Have you any further side effects from treatment?' 'Do you need to make an appointment to be seen in the Radiotherapy department before your outpatient appointment?' Patients were asked if they had any additional worries or concerns. Wherever possible, the appropriate action was taken. A simple log form was completed for each telephone call, recording the responses to the set questions and any other relevant information. All patients were seen once a week in the clinic by a doctor during treatment. Additional advice and support was given, where necessary, by radiographers and nurses. In the group given usual care, no attempt was made to contact the patients between completing treatment and the first follow-up visit. If patients telephoned the department for advice and support this was, of course, provided. The assessment of the intervention was made at the first follow-up visit, 4 weeks after completing treatment. Two simple questionnaires were used,
Telephone Contact FollowingCompletion of Radiotherapy one for the control group and one for the group who had been contacted by telephone (Appendix). All patients were asked question 1; only patients in the intervention group were asked question 2. The statistical analysis of the results was performed in two ways: according to intention to treat, to evaluate the effectiveness of a policy of intervention; and according to the results obtained from the completed questionnaires, to evaluate the effectiveness of the intervention itself. Fisher's exact test and Z2 tests were used for testing significance. The required sample size was calculated as follows. We wished to be 90% certain (/3 = 0.1) that we had excluded, at o: = 0.05, the possibility that intervention produced an improvement in the proportion of patients describing support as extremely adequate, from 0.2 in controls to 0.5 in the intervention arm. Based on standard tables for one-sided significance testing we required 48 patients randomized to each arm [2]. Our planned study size was therefore 100 patients.
RESULTS
The demographic data on the 100 patients randomized (49 intervention, 51 controls) and the sites of primary turnout are shown in Table 1. Five of the 49 patients randomized to the intervention group were not telephoned because of deterioration in their clinical condition or admission to hospital. Of the remaining 44 patients, 33 (75%) completed questionnaires. Questionnaires were completed by 39/51 (79.6%) of patients in the control group. When analysed by intention to treat, the rate difference was 4% (95% CI - 1 7 - + 2 5 ) in favour of the intervention; 24/51 (47%) of controls, versus 24/ 49 (51%) of the intervention group, described support after treatment as extremely adequate. The analysis of the 72 completed questionnaires showed a rate difference of 15% (95% CI -6--+36) favouring intervention; 24/39 (61%) of controls versus 25/33 (76%) of the experimental group described support after treatment as extremely adequate (P=0.150 by Fisher's exact test). The responses to the first part of Table 1. Demographic data and sites of primary tumours for the 100 randomized patients
Females Males Total Median age (years) Range Site Breast Lung Head and neck Rectum Lymphoma Skin
Controls
Intervention
30 21 51 65 37-88
28 21 49 63 30-87
22 16 4 4 1 4
21 15 5 1
5 2
243 Table 2. Responsesto first part of the questionnaire (commonto
both groups) Response
Controls
Intervention
Extremely adequate Adequate Less than adequate Totally adequate
24 14 0 1
25 7 1 0
the questionnaire common to both groups are shown in Table 2. The ~ value (overall) was 3.88 (P = 0.275, 3 df) and )7 for trend is 1.39 (P=0.24, 1 df) The patients in the telephone contact group found the calls either extremely helpful (88%) or moderately helpful (12%). No patient considered that the calls had been an invasion of privacy. Of the 127 phone calls made, 23 (18%) elicited problems which would otherwise have been unidentified. Only one patient needed to have their routine follow-up appointment advanced; 39% of problems concerned radiation reactions, 26% were because patients had not yet received their follow-up appointment, and 30% involved worries and uncertainties related to the primary diagnosis. The average duration of each telephone call was approximately 5 minutes; this included repeated calls made to patients who did not initially answer the telephone. A policy of four phone calls made routinely after treatment requires an average of 20 minutes of staff time per patient. The hourly rate of pay of an intermediate-grade radiographer is £10. In a department seeing 3000 new patients per year the cost of routine telephone support after treatment would be approximately £10 000 or 0.75 whole time equivalent (WTE).
DISCUSSION
This study confirms the result of a smaller previous study [3], that it is not possible to demonstrate objectively any benefit from routine telephone contact for patients who have completed radiotherapy. Detsky and Sackett have provided a method of assessing, after a trial has been completed, whether or not an apparently negative study is falsely negative [4]. In our original sample size calculation an absolute rate difference of 30% was regarded as clinically significant. This corresponds (given that the proportion of patients in the control arm who regarded their support as extremely adequate was 51%), to a relative rate difference of 60% (30/51 × 100). Our trial was certainly large enough to exclude the possibility that a true difference of this magnitude was missed. Only 15 patients are required in each arm to exclude a 50% relative rate difference when the observed rates in the control and experimental arms are 47% and 51% respectively. In patients actually completing questionnaires, 76% of the intervention
244
group versus 61% of controls defined their support as extremely adequate. Given these event rates, we would have needed only 24 patients randomized to exclude a relative rate difference between arms of 50% (equivalent to an absolute rate difference of, 30%). We can be confident therefore that our study was large enough to exclude the possibility that intervention produces an effect we regard as worthwhile. The telephone calls were undoubtedly appreciated by patients; comments such as 'it was nice to know someone still cared after I had finished at the hospital' were added to several of the questionnaires. The surprising finding, perhaps, comes from the control group: 60% of patients given our routine support during treatment, but no specific support after treatment, found their support 'extremely adequate'. The apparent paradox, that telephone contact was appreciated, but that the lack of such contact did not influence the perceived adequacy of support, can be resolved fairly simply: what you have never had you do not miss. This study indicates clearly that well-meaning interventions applied routinely can be expensive and that they cannot be justified simply because they are appreciated by patients. Neither this study, nor the previous similar study [3], has shown any clear benefit from telephoning patients after the completion of radiotherapy. A routine policy of such intervention for all patients cannot, given the present limitations on resources, be justified. Certain patients, for example those who are anxious or feel socially isolated, might benefit from telephone contact after treatment. Our next study will assess the effectiveness of targeted intervention.
Acknowledgements.We would like to thank
all those radiographers, nurses and doctors who made and documented the telephone calls.
A . J . Munro et al.
References 1. Eardley A. Patients and radiotherapy: 3. Patients' experiences after discharge. Radiography 1986;52:17-9. 2. George SL. The required size and length of a Phase III clinical trial. Buyse ME, Staquet MJ, Sylvester RJ, editors. Cancer clinical trials: Methods and practice. Oxford: Oxford Medical Publications, 1988:287-310. 3. Hagopian GA, Rubenstein JH. Effects of telephone call interventions on patients' well-being in a radiotherapy department. Cancer Nurs 1990;13:33%44. 4. Detsky AS, Sackett DL. When was a 'negative' clinical trial big enough? How many patients you needed depends upon what you found. Arch Intern Med 1985;145:709-12.
APPENDIX Questionnaire: After Radiotherapy We are currently trying to find out whether we provide sufficient support for patients after they finish radiotherapy. We would be very grateful if you could fill in the following short questionnaire. Your answers are strictly confidential and none of the doctors or nurses looking after you will know what you have said. Please put a ring around the answer that most closely applies to you. 1. Was the support and information given to you after completion of your treatment: Extremely adequate Adequate Less than adequate Totally inadequate 2. Were the telephone calls you received from our department after you finished your treatment: Extremely helpful and supportive Moderately helpful and supportive Of no real use An invasion of privacy Received for publication November 1993 Accepted following revision April 1994
Clinical Oncology
Original Article A Randomized Study of Telephone Contact Following Completion of Radiotherapy A. J. Munro, T. Shaw, L. Clarke, L. Becker and S. Greenwood Department of Radiotherapy, St Bartholomew's Hospital, London, UK
Abstract. The hypothesis tested was that routine contact by telephone might significantly improve the adequacy of support for patients during the potentially stressful period between completing radiotherapy and the first follow-up visit. The study was a randomized controlled trial in which 100 patients were allocated either to telephone contact (intervention arm) or usual care (control arm). Adequacy of support was assessed by a questionnaire administered at the first follow-up visit. There were no significant differences in the perceived adequacy of support between the two arms. Of the 72 patients who completed questionnaires, 76% of those in the intervention arm versus 61% in the control arm rated their support after radiotherapy as 'extremely adequate'. The 95% confidence interval (CI) for this 15% rate difference was - 6 +36. Analysis by intention to treat showed a rate difference of only 4% (95% CI - 1 7 - + 2 5 ) in favour of intervention. We conclude that, given the limited resources currently available, it is not possible to justify a policy of routine contact by telephone for all patients completing radiotherapy. Keywords: Patient support; Psychosocial oncology; Radiotherapy; Telephone contact
INTRODUCTION There is anecdotal evidence to suggest that patients with cancer find the period immediately after the completion of intensive treatment to be particularly stressful [1]. The problem may arise, in part, from the withdrawal of routine daily contact with the hospital. Patients sometimes feel, between completing treatment and the first follow-up, as if they are in limbo. Irrational fears may arise, such as, 'They are not seeing me at the hospital any more because treatment has failed and there is nothing more they can do.' It is possible that adverse reactions to the withCorrespondence and offprint requests to: A. J. Munro, Consultant Radiotherapist, Department of Radiotherapy, St Bartholomew's Hospital, West Smithfield, London EC1A 7BE, UK.
drawal of daily contact with the hospital might be mitigated by routine telephone calls to patients during the interval between the end of treatment and first follow-up visit. We performed a randomized controlled study to investigate this hypothesis.
PATIENTS AND METHODS Consecutive unselected outpatients attending for radiotherapy under the care of one consultant were considered for entry into the study. The following groups of patients were ineligible: patients who did not understand English; those who did not have a telephone; patients with HIV related malignancies; those treated with less than five fractions of radiotherapy; and hospital inpatients. Eligible patients were randomized between usual care during and after treatment, and usual care plus telephone contact. Telephone contact comprised telephone calls to the patient on days 4, 8, 14 and 18 after completing radiotherapy. The telephone calls were made by a member of staff, radiographer, nurse, or doctor who was known to the patient. The calls were semistructured, the questions to be asked being: 'How are you feeling?' 'Are you having any problems?' 'Have you any further side effects from treatment?' 'Do you need to make an appointment to be seen in the Radiotherapy department before your outpatient appointment?' Patients were asked if they had any additional worries or concerns. Wherever possible, the appropriate action was taken. A simple log form was completed for each telephone call, recording the responses to the set questions and any other relevant information. All patients were seen once a week in the clinic by a doctor during treatment. Additional advice and support was given, where necessary, by radiographers and nurses. In the group given usual care, no attempt was made to contact the patients between completing treatment and the first follow-up visit. If patients telephoned the department for advice and support this was, of course, provided. The assessment of the intervention was made at the first follow-up visit, 4 weeks after completing treatment. Two simple questionnaires were used,
Telephone Contact FollowingCompletion of Radiotherapy one for the control group and one for the group who had been contacted by telephone (Appendix). All patients were asked question 1; only patients in the intervention group were asked question 2. The statistical analysis of the results was performed in two ways: according to intention to treat, to evaluate the effectiveness of a policy of intervention; and according to the results obtained from the completed questionnaires, to evaluate the effectiveness of the intervention itself. Fisher's exact test and Z2 tests were used for testing significance. The required sample size was calculated as follows. We wished to be 90% certain (/3 = 0.1) that we had excluded, at o: = 0.05, the possibility that intervention produced an improvement in the proportion of patients describing support as extremely adequate, from 0.2 in controls to 0.5 in the intervention arm. Based on standard tables for one-sided significance testing we required 48 patients randomized to each arm [2]. Our planned study size was therefore 100 patients.
RESULTS
The demographic data on the 100 patients randomized (49 intervention, 51 controls) and the sites of primary turnout are shown in Table 1. Five of the 49 patients randomized to the intervention group were not telephoned because of deterioration in their clinical condition or admission to hospital. Of the remaining 44 patients, 33 (75%) completed questionnaires. Questionnaires were completed by 39/51 (79.6%) of patients in the control group. When analysed by intention to treat, the rate difference was 4% (95% CI - 1 7 - + 2 5 ) in favour of the intervention; 24/51 (47%) of controls, versus 24/ 49 (51%) of the intervention group, described support after treatment as extremely adequate. The analysis of the 72 completed questionnaires showed a rate difference of 15% (95% CI -6--+36) favouring intervention; 24/39 (61%) of controls versus 25/33 (76%) of the experimental group described support after treatment as extremely adequate (P=0.150 by Fisher's exact test). The responses to the first part of Table 1. Demographic data and sites of primary tumours for the 100 randomized patients
Females Males Total Median age (years) Range Site Breast Lung Head and neck Rectum Lymphoma Skin
Controls
Intervention
30 21 51 65 37-88
28 21 49 63 30-87
22 16 4 4 1 4
21 15 5 1
5 2
243 Table 2. Responsesto first part of the questionnaire (commonto
both groups) Response
Controls
Intervention
Extremely adequate Adequate Less than adequate Totally adequate
24 14 0 1
25 7 1 0
the questionnaire common to both groups are shown in Table 2. The ~ value (overall) was 3.88 (P = 0.275, 3 df) and )7 for trend is 1.39 (P=0.24, 1 df) The patients in the telephone contact group found the calls either extremely helpful (88%) or moderately helpful (12%). No patient considered that the calls had been an invasion of privacy. Of the 127 phone calls made, 23 (18%) elicited problems which would otherwise have been unidentified. Only one patient needed to have their routine follow-up appointment advanced; 39% of problems concerned radiation reactions, 26% were because patients had not yet received their follow-up appointment, and 30% involved worries and uncertainties related to the primary diagnosis. The average duration of each telephone call was approximately 5 minutes; this included repeated calls made to patients who did not initially answer the telephone. A policy of four phone calls made routinely after treatment requires an average of 20 minutes of staff time per patient. The hourly rate of pay of an intermediate-grade radiographer is £10. In a department seeing 3000 new patients per year the cost of routine telephone support after treatment would be approximately £10 000 or 0.75 whole time equivalent (WTE).
DISCUSSION
This study confirms the result of a smaller previous study [3], that it is not possible to demonstrate objectively any benefit from routine telephone contact for patients who have completed radiotherapy. Detsky and Sackett have provided a method of assessing, after a trial has been completed, whether or not an apparently negative study is falsely negative [4]. In our original sample size calculation an absolute rate difference of 30% was regarded as clinically significant. This corresponds (given that the proportion of patients in the control arm who regarded their support as extremely adequate was 51%), to a relative rate difference of 60% (30/51 × 100). Our trial was certainly large enough to exclude the possibility that a true difference of this magnitude was missed. Only 15 patients are required in each arm to exclude a 50% relative rate difference when the observed rates in the control and experimental arms are 47% and 51% respectively. In patients actually completing questionnaires, 76% of the intervention
244
group versus 61% of controls defined their support as extremely adequate. Given these event rates, we would have needed only 24 patients randomized to exclude a relative rate difference between arms of 50% (equivalent to an absolute rate difference of, 30%). We can be confident therefore that our study was large enough to exclude the possibility that intervention produces an effect we regard as worthwhile. The telephone calls were undoubtedly appreciated by patients; comments such as 'it was nice to know someone still cared after I had finished at the hospital' were added to several of the questionnaires. The surprising finding, perhaps, comes from the control group: 60% of patients given our routine support during treatment, but no specific support after treatment, found their support 'extremely adequate'. The apparent paradox, that telephone contact was appreciated, but that the lack of such contact did not influence the perceived adequacy of support, can be resolved fairly simply: what you have never had you do not miss. This study indicates clearly that well-meaning interventions applied routinely can be expensive and that they cannot be justified simply because they are appreciated by patients. Neither this study, nor the previous similar study [3], has shown any clear benefit from telephoning patients after the completion of radiotherapy. A routine policy of such intervention for all patients cannot, given the present limitations on resources, be justified. Certain patients, for example those who are anxious or feel socially isolated, might benefit from telephone contact after treatment. Our next study will assess the effectiveness of targeted intervention.
Acknowledgements.We would like to thank
all those radiographers, nurses and doctors who made and documented the telephone calls.
A . J . Munro et al.
References 1. Eardley A. Patients and radiotherapy: 3. Patients' experiences after discharge. Radiography 1986;52:17-9. 2. George SL. The required size and length of a Phase III clinical trial. Buyse ME, Staquet MJ, Sylvester RJ, editors. Cancer clinical trials: Methods and practice. Oxford: Oxford Medical Publications, 1988:287-310. 3. Hagopian GA, Rubenstein JH. Effects of telephone call interventions on patients' well-being in a radiotherapy department. Cancer Nurs 1990;13:33%44. 4. Detsky AS, Sackett DL. When was a 'negative' clinical trial big enough? How many patients you needed depends upon what you found. Arch Intern Med 1985;145:709-12.
APPENDIX Questionnaire: After Radiotherapy We are currently trying to find out whether we provide sufficient support for patients after they finish radiotherapy. We would be very grateful if you could fill in the following short questionnaire. Your answers are strictly confidential and none of the doctors or nurses looking after you will know what you have said. Please put a ring around the answer that most closely applies to you. 1. Was the support and information given to you after completion of your treatment: Extremely adequate Adequate Less than adequate Totally inadequate 2. Were the telephone calls you received from our department after you finished your treatment: Extremely helpful and supportive Moderately helpful and supportive Of no real use An invasion of privacy Received for publication November 1993 Accepted following revision April 1994