Introduction

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There is increasing interest in home care as an alternative to hospitalisation, particularly because of its potential for achieving cost savings by reducing levels of inpatient care.¹ However, evidence for cost savings from home care has been limited to specific pathologies such as chronic obstructive pulmonary disease.² The feasibility and cost effectiveness of home care depends on the setting studied, the type of treatment given, and the analytical methods used,³ and few trials have assessed the impact of home care on outcomes that would be relevant in the context of a given organisational change.

Most oncology centres give chemotherapy in an outpatient setting. However, chemotherapy is often cited as a procedure that may be suitable for home administration. ^{4 5} The aim of the present study was to analyse safety, compliance, satisfaction with treatment, quality of life, and use of health services for adult cancer patients receiving chemotherapy for colorectal cancer in an outpatient clinic compared with a home setting.

	Participants and methods

Top Abstract Introduction Participants and methods Results Discussion References

Patients
Between October 1997 and October 1998 we selected patients referred to the medical oncology department of the Catalan Institute of Oncology with a diagnosis of colorectal cancer for whom treatment with adjuvant or palliative chemotherapy was indicated. To be eligible for our study, patients had to be between 18 and 75 years old, have a diagnosis of colorectal cancer, and be suitable for treatment with bolus fluorouracil based chemotherapy as adjuvant treatment or as treatment for disseminated disease according to the institutional protocol. The patients gave their written informed consent, and the hospital ethics and research committee approved the study protocol.

Randomisation
We randomly assigned the patients to receive chemotherapy either at the outpatient clinic (standard care) or at home, stratified according to the type of tumour (colon, rectum, or advanced disease). We calculated sample size to detect a difference of 8 (SD 3) between groups for self rated general health status.

Treatment
Adjuvant chemotherapy consisted of bolus fluorouracil with levamisole for five consecutive days during the first cycle and once a week thereafter until completion of 12 months' treatment, or bolus fluorouracil with folinic acid for five days a week (or three days in the case of combined chemoradiotherapy) every four weeks until completion of six cycles of treatment. Palliative chemotherapy consisted of bolus fluorouracil with folinic acid for five days a week every four weeks until completion of six to eight cycles if disease was stable or until disease progression was observed. Patients in the home chemotherapy group were required to visit the hospital every four weeks. A trained nurse delivered the home chemotherapy.

Outcome measures
Treatment toxicity We measured and recorded treatment toxicity every four weeks using the ECOG classification.⁶

Quality of life

Statistical analysis
We calculated point estimates and 95% confidence intervals for the differences between groups in percentages, means, and change between the initial and final questionnaire scores. We used analysis of variance for repeated measures to compare patients' quality of life and satisfaction scores, both before and after treatment and between the groups.

	Results

Top Abstract Introduction Participants and methods Results Discussion References

We recruited 87 patients to the trial (figure). The groups were comparable at baseline (table 1).

View larger version (27K): [in this window] [in a new window]   Progress of participants through trial

Withdrawals and treatment toxicityVoluntary withdrawals from chemotherapy were significantly higher in the outpatient treatment group (difference 12% (95% confidence interval 1% to 24%)). Overall, one in three patients did not complete chemotherapy (table 2).

Use of healthcare resourcesThe groups showed no significant differences in use of healthcare resource for unplanned visits.

Quality of lifeThere were no differences between groups in quality of life, neither at the initial assessment or once treatment was completed nor in terms of changes in scores during the trial. Insomnia was the symptom with the highest impact on the quality of life (final score of 32 in outpatient treatment group v 23 in home treatment group), followed by fatigue (30 v 29), and pain (19 v 20). For more detail, see the full version of this paper on bmj.com.

Satisfaction with health careThere were no differences between groups in scores on the initial satisfaction questionnaire. However, when we assessed patients' satisfaction after completion of treatment we found a significant difference between groups in the perception of nursing availability, with the hospital outpatients considering that they had to wait longer to receive chemotherapy than the patients treated at home (table 3). Communication with nurses and the personal qualities of the nurses were also rated more highly by the home group. Global satisfaction with health care was higher in the home group, but the difference was not significant.

	Discussion

Top Abstract Introduction Participants and methods Results Discussion References

The results of this study indicate that home chemotherapy for patients with colorectal cancer is a safe and acceptable alternative to outpatient hospital treatment. No major complications occurred, showing that this type of chemotherapy can be safely administered outside hospital. From the point of view of implementation and impact on healthcare systems, it is worth noting that we found no differences between groups in use of non-programmed health resources, suggesting that home chemotherapy did not increase the use of other health services such as primary care or emergency departments.

Study limitations
Our study was limited to a specific treatment for colorectal cancer. This treatment was common at the time our study was planned, but the results may not apply to newer or more complicated chemotherapy regimens. However, our results would probably be applicable to other tumours and some chemotherapy programmes.

Conclusions
This study is one of the first trials in chemotherapy to evaluate the impact of organisational change on a variety of outcomes. It is surprising that, while considerable effort is devoted to assessing the benefits and risks of drugs, much less attention is paid to understanding how the mode of administration affects important outcomes such as use of health services or satisfaction with care. A recent review of the effect of home care programmes on the quality of life of patients with incurable cancer and on use of hospital resources concluded that the effectiveness of such programmes remains unclear and that research is needed before such programmes are expanded.¹⁰ Our study contributes to the assessment of home care for cancer patients and has shown that home chemotherapy could be advantageous for patients by increasing satisfaction and compliance with treatment.

	Acknowledgments

We thank the EORTC for permission given to use the EORTC QOL-C30 quality of life questionnaire. We thank C Fernandez, M Garcia, X Puig, and V Moreno for helping to make this study possible, and M Herdman for his revision of the English version of this manuscript. Preliminary results of this study were presented at the seventh meeting of the Spanish Society of Medical Oncology and at the sixth annual meeting of the International Society for Quality of Life Research.

Contributors: JMB and JRG had the idea for the study, obtained the grant, and managed the project. EM and AS-H supervised the study and contributed to the study design and data collection. EM was the monitor of the trial. JAE conducted the analysis and helped in interpreting the data. MN, JLLP, and MM supervised the medical, pharmaceutical, and nursing processes and helped in interpreting the data. JMB and AS-H wrote the first version of the paper, all authors reviewed the paper and contributed to the final version. JMB and JRG are guarantors for the study.

	Footnotes

Funding: Research grant from the Catalan Agency for Technology Assessment in Health Care (contract 1996/273).

Competing interests: None declared.

The full version of this paper is available on the BMJ's website

	References

Top Abstract Introduction Participants and methods Results Discussion References

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(Accepted 5 January 2001)