BMJ 2001;322:826 [Full] ( 7 April )
Papers
Compliance, satisfaction, and quality of life of patients
with colorectal cancer receiving home chemotherapy or outpatient treatment: a
randomised controlled trial
J M Borras
a Cancer Prevention and Control Unit,
Catalan Institute of Oncology, Gran Via Km 2,7 s/n, 08907-Hospitalet,
Spain, b Department of Medical Oncology, Catalan Institute of
Oncology, c Department of Pharmacy, Catalan Institute of
Oncology
Correspondence to: J M Borras [log in to unmask]
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Abstract |
Objective: To compare chemotherapy given at home
with outpatient treatment in terms of colorectal cancer patients'
safety, compliance, use of health services, quality of life, and
satisfaction with treatment.
Design: Randomised controlled
trial.
Setting: Large teaching hospital.
Participants: 87 patients
receiving adjuvant or palliative chemotherapy for colorectal cancer.
Interventions: Treatment with
fluorouracil (with or without folinic acid or levamisole) at
outpatient clinic or at home.
Main outcome measures: Treatment
toxicity; patients' compliance with treatment, quality of life,
satisfaction with care, and use of health resources.
Results: 42 patients were treated
at outpatient clinic and 45 at home. The two groups were
balanced in terms of age, sex, site of cancer, and disease stage.
Treatment related toxicity was similar in the two groups (difference
7% (95% confidence interval 
12%
to 26%)), but there were more voluntary withdrawals from treatment
in the outpatient group than in the home group (14% v 2%, difference 12% (1% to 24%)). There
were no differences between groups in terms of quality of life
scores during and after treatment. Levels of patient satisfaction
were higher in the home treatment group, specifically with regard to
information received and nursing care. There were no significant
differences in use of health services.
Conclusions: Home chemotherapy
seemed an acceptable and safe alternative to hospital treatment for
patients with colorectal cancer that may improve compliance and
satisfaction with treatment.
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What is already known on this topic However, they are more costly, and there is
little evidence on their impact on outcomes such as compliance, quality of
life, or use of other health services What this study adds Home chemotherapy had no effect on
patients' quality of life but increased their compliance with treatment and
satisfaction, particularly with regard to nursing care Home chemotherapy seems an acceptable and
safe alternative to outpatient treatment that may improve compliance with
treatment |
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Introduction |
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.
Chemotherapy is often cited as a procedure that may be suitable for
home administration. 4
5
However, only one trial has assessed the effect of administering
chemotherapy at home (on quality of life, satisfaction, costs, and
safety for paediatric cancer patients),6 while
one other trial has compared the effectiveness of administering chemotherapy
in inpatient and outpatient settings.7 The first
of these studies found that administration of selected chemotherapy at
home reduced costs, and the second study found that outpatient care
was significantly less costly than inpatient care. Recently, two
Australian crossover trials produced inconsistent results with
regard to patients' preferences for home chemotherapy but consistently
indicated that it is more costly than outpatient care, although the
benefits to patients (travel time, family costs, etc) were not
assessed. 8
9
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.
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Participants and methods |
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. We excluded patients living outside a
30 km radius of the hospital. All but one of the patients invited to
participate in the study accepted. 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. The patient was
the randomisation unit. Random numbers were selected in block of
eight, stratified according to the type of tumour (colon, rectum, or
advanced disease). We calculated sample size (two sided, 
=0.05, 1b=0.80) to detect a
difference of 8 (SD 3) between groups for self rated general
health status and then increased this calculated sample size
(41 patients for each group) by a total of six patients to
allow for patients withdrawing from the trial.
Treatment
Colon cancer adjuvant chemotherapy consisted of bolus fluorouracil
(450 mg for five consecutive days during the first cycle and
once a week thereafter) with levamisole (50 mg/8 hours, oral,
for three consecutive days every 15 days) until completion of
12 months' treatment. Rectal cancer adjuvant chemotherapy consisted
of bolus fluorouracil (500 mg/m2) for five consecutive days a
week (or three consecutive days in case of combined
chemoradiotherapy) until completion of six cycles of treatment.
Palliative chemotherapy consisted of bolus fluorouracil
(425 mg/m2) with folinic acid (20 mg/m2) for
five consecutive days a week every four weeks until completion of
six to eight cycles if disease was stable or disease progression was
observed.
A trained nurse delivered the home
chemotherapy. Decisions to modify the dose were made by the medical oncologist
at the monthly visit to consider toxicity during the previous cycle.
A protocol, including a telephone call to an oncologist, was
established in order to manage acute adverse effects that could
appear while delivering home chemotherapy.
Outcome measures
Treatment toxicity 
We measured and recorded treatment toxicity every
four weeks using the ECOG classification.10 Grade
3 or 4 toxicity resulted in withdrawal from the trial.
Withdrawal from
trialWe classified
reasons for withdrawing from the trial as unacceptable toxicity of chemotherapy
(grade 3 or greater), disease progression, or voluntary
withdrawal not related to previous causes. Only the last category
was considered as patient non-compliance.
Use of healthcare
resourcesWe asked patients about any unplanned use of primary care or
emergency department or hospitalisation. We categorised any use of
health services not covered in the protocol, including visits to the
emergency department or outpatient clinics and admission to hospital
or to a primary care centre. We considered all primary care visits
to be unscheduled even when they were related to comorbid conditions.
Quality of lifeWe
measured patients' quality of life with the EORTC QOL-C30 questionnaire.11 This
includes five functional scales (physical, role (related to
interference of disease with family life or social activities),
emotional, cognitive, and social), a global health status quality of
life scale, and single measures of symptom severity (fatigue, nausea
and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation,
diarrhoea, and financial difficulties). We also measured quality of
life using the Karnofsky index.12
Satisfaction with
health careWe assessed patients' satisfaction using a questionnaire
translated into Spanish for this study (available from JMB).13 This
included several items that measured general satisfaction with
health care received, availability of doctors, nursing availability
(related to waiting time), continuity of care, personal qualities of
nurses (related to perceived interest in the patient), and
communication with doctors and nurses. We scored the responses on a
scale of 1 (completely disagree) to 5 (completely agree).
Raw scores were linearly transformed to values between 0 and
100. In all domains a higher score indicated greater
satisfaction. We determined the internal consistency (reliability) of
the scales using Cronbach's coefficient ,14
with coefficients over 0.7 being considered sufficient for
group comparisons.15
The coefficient
fell below this threshold in only one domain (nursing availability).
We administered the quality of life and
satisfaction questionnaires at the start of the trial, every three months, and
at the end of treatment.
Statistical analysis
We calculated point estimates and 95% confidence intervals for the
differences in percentages and means between groups. 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. We calculated means and 95%
confidence intervals for the difference in the size of the change
between the initial and final questionnaire scores for the two
groups.
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Results |
We recruited 87 patients to the trial, 42 assigned to
hospital outpatient treatment and 45 to home treatment (figure). The groups
were balanced according to age, sex, and type of treatment received
(table 1), and there
were no differences in toxicity.
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Withdrawals and treatment toxicityVoluntary withdrawals from chemotherapy were significantly higher
in the outpatient treatment group (difference 12% (95% confidence
interval 1% to 24%)), but there were no differences between groups
for withdrawals due to medical reasons (toxicity or disease
progression). Overall, one in three patients did not complete
chemotherapy (table 2).
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Use of healthcare resourcesThe groups showed no significant differences in use of healthcare
resource for unplanned visits (table 3).
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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 (table 4). Insomnia was the
commonest symptom, followed by fatigue, pain, and appetite loss.
Role functioning improved after treatment in both groups, although
changes in scores were not significant. Scores on the Karnofsky
scale and global health status remained stable.
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Satisfaction with health careThere were no differences between groups in scores on the initial
satisfaction questionnaire (results not shown). 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 5). 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.
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Discussion |
The results of this study indicate that home chemotherapy for
patients with colorectal cancer is a safe and acceptable alternative to
outpatient hospital treatment. All but one of the eligible patients
we asked agreed to participate in the trial. 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.
Quality of care
There were no differences in quality of life or toxicity between the
two groups, as was found in a recent study.9 In
patients with advanced disease it has been found that quality of
life could be affected by the psychological and social impact of the
disease and its treatment, which can be more stressful in hospital.16 Patients
receiving chemotherapy at home reported higher levels of
satisfaction with care, which was largely due to higher levels of
satisfaction with the nursing staff. Home care probably allowed the
nurses to establish a better relationship with patients. With home
treatment, nurses are able to devote time exclusively to the
patient, thereby leading to improved perceptions of nurses' personal
qualities and availability.
The issue of compliance has not received much
attention in oncology. 17
18 A
review of non-compliance with drugs administered by a provider, as
in our study, found rates of non-compliance ranging from 16% to 33%.19 In
total, 8% of our patients voluntarily withdrew from treatment.
Obviously, the drug provider may play an important role in reducing
non-compliance, and of our 8% of patients who did not comply with
treatment, the proportion in the home group was only 2%. This
difference might have been because withdrawal from treatment and
reduced appointment keeping are due more to the interference of
adverse effects on daily activities than to the adverse effects
themselves.20
This type of interference is probably easier to manage when
treatment is administered at home.
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.
We did not perform a detailed cost analysis
because the study was planned under a hospital perspective in a context of
increasing demand for cancer treatments, where it was fairly obvious
that a home programme would require additional resources. However,
home chemotherapy could be an economically realistic alternative to
hospital treatment if we consider indirect benefits to patients.21
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.22
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.
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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.
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Footnotes |
Funding: Research grant from the Catalan Agency for Technology
Assessment in Health Care (contract 1996/273).
Competing interests: None declared.
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(Accepted 5 January 2001)
Edward
E. Rylander, M.D.
D.A.B.F.P and
D.A.B.P.M.