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, head of the unit a, A Sanchez-Hernandez, medical oncologist b, M
Navarro, medical oncologist b, M Martinez, research nurse a, E Mendez,
research fellow a, J L L Ponton, head of department c, J A Espinas, research
fellow a, J R Germa, head of department b.
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]
<mailto:[log in to unmask]>



  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.




What is already known on this topic
Home chemotherapy programmes have been proposed as an alternative to
hospital treatment
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 was not associated with an increased use of health
services such as primary care or emergency departments
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





  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
<http://bmj.com/cgi/content/full/322/7290/#B1>  However, evidence for cost
savings from home care has been limited to specific pathologies such as
chronic obstructive pulmonary disease. 2
<http://bmj.com/cgi/content/full/322/7290/#B2>  The feasibility and cost
effectiveness of home care depends on the setting studied, the type of
treatment given, and the analytical methods used, 3
<http://bmj.com/cgi/content/full/322/7290/#B3>  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 <http://bmj.com/cgi/content/full/322/7290/#B4>  5
<http://bmj.com/cgi/content/full/322/7290/#B5>  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
<http://bmj.com/cgi/content/full/322/7290/#B6>  while one other trial has
compared the effectiveness of administering chemotherapy in inpatient and
outpatient settings. 7 <http://bmj.com/cgi/content/full/322/7290/#B7>  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
<http://bmj.com/cgi/content/full/322/7290/#B8>  9
<http://bmj.com/cgi/content/full/322/7290/#B9>
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
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, alpha =0.05, 1-b=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
<http://bmj.com/cgi/content/full/322/7290/#B10>  Grade 3 or 4 toxicity
resulted in withdrawal from the trial.
Withdrawal from trial---We 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 resources---We 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 life---We measured patients' quality of life with the EORTC
QOL-C30 questionnaire. 11 <http://bmj.com/cgi/content/full/322/7290/#B11>
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 <http://bmj.com/cgi/content/full/322/7290/#B12>
Satisfaction with health care---We assessed patients' satisfaction using a
questionnaire translated into Spanish for this study (available from JMB).
13 <http://bmj.com/cgi/content/full/322/7290/#B13>  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 alpha , 14 <http://bmj.com/cgi/content/full/322/7290/#B14>  with
coefficients over 0.7 being considered sufficient for group comparisons. 15
<http://bmj.com/cgi/content/full/322/7290/#B15>  The alpha  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.


 <http://bmj.com/cgi/content/full/322/7290/826/Fu2>
View larger version (27K):
[in this window] <http://bmj.com/cgi/content/full/322/7290/826/Fu2>
[in a new window] <http://bmj.com/cgi/content-nw/full/322/7290/826/Fu2>

Progress of participants through trial






  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
<http://bmj.com/cgi/content/full/322/7290/#T1> ), and there were no
differences in toxicity.



View this table:
[in this window] <http://bmj.com/cgi/content/full/322/7290/826/T1>
[in a new window] <http://bmj.com/cgi/content-nw/full/322/7290/826/T1>

Table 1. Baseline characteristics of 87 patients with colorectal cancer
assigned to chemotherapy at hospital outpatient clinic or at home. Values
are numbers (percentages) unless stated otherwise
Withdrawals and treatment toxicity---Voluntary 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 <http://bmj.com/cgi/content/full/322/7290/#T2> ).



View this table:
[in this window] <http://bmj.com/cgi/content/full/322/7290/826/T2>
[in a new window] <http://bmj.com/cgi/content-nw/full/322/7290/826/T2>

Table 2. Compliance with treatment by 87 patients with colorectal cancer
assigned to chemotherapy at hospital outpatient clinic or at home. Values
are numbers (percentages) unless stated otherwise
Use of healthcare resources---The groups showed no significant differences
in use of healthcare resource for unplanned visits (table 3
<http://bmj.com/cgi/content/full/322/7290/#T3> ).



View this table:
[in this window] <http://bmj.com/cgi/content/full/322/7290/826/T3>
[in a new window] <http://bmj.com/cgi/content-nw/full/322/7290/826/T3>

Table 3. Non-programmed use of healthcare resources by 56 patients with
colorectal cancer assigned to chemotherapy at hospital outpatient clinic or
at home. Values are mean (SD) number of visits during treatment unless
stated otherwise
Quality of life---There 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
<http://bmj.com/cgi/content/full/322/7290/#T4> ). 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.



View this table:
[in this window] <http://bmj.com/cgi/content/full/322/7290/826/T4>
[in a new window] <http://bmj.com/cgi/content-nw/full/322/7290/826/T4>

Table 4. Quality of life reported by 87 patients with colorectal cancer
assigned to chemotherapy at hospital outpatient clinic or at home. Values
are means (SD) unless stated otherwise
Satisfaction with health care---There 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 <http://bmj.com/cgi/content/full/322/7290/#T5> ). 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.



View this table:
[in this window] <http://bmj.com/cgi/content/full/322/7290/826/T5>
[in a new window] <http://bmj.com/cgi/content-nw/full/322/7290/826/T5>

Table 5. Satisfaction* with medical care reported by 56 patients with
colorectal cancer after chemotherapy at hospital outpatient clinic or at
home. Values are means (SD) unless stated otherwise





  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
<http://bmj.com/cgi/content/full/322/7290/#B9>  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
<http://bmj.com/cgi/content/full/322/7290/#B16>  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
<http://bmj.com/cgi/content/full/322/7290/#B17>  18
<http://bmj.com/cgi/content/full/322/7290/#B18>  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
<http://bmj.com/cgi/content/full/322/7290/#B19>  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 <http://bmj.com/cgi/content/full/322/7290/#B20>  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 <http://bmj.com/cgi/content/full/322/7290/#B21>
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 <http://bmj.com/cgi/content/full/322/7290/#B22>
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.



  References
Top <http://bmj.com/cgi/content/full/322/7290/#Top>
Abstract <http://bmj.com/cgi/content/full/322/7290/#Abstract>
Introduction <http://bmj.com/cgi/content/full/322/7290/#SEC1>
Participants and methods <http://bmj.com/cgi/content/full/322/7290/#SEC2>
Results <http://bmj.com/cgi/content/full/322/7290/#SEC3>
Discussion <http://bmj.com/cgi/content/full/322/7290/#SEC4>
References


1.
Benjamin AE. An historical perspective on home care policy. Milbank Q 1993;
71: 129-166 [Medline]
<http://bmj.com/cgi/external_ref?access_num=8450819&link_type=MED> .
2.
Sodestrom L, Tonsignant P, Kaufman T. The health and costs effects of
substituting home care for inpatient acute care: a review of the evidence.
Can Med Assoc J 1999; 160: 1151-1155.
3.
Shepperd S, Illife S. Effectiveness of hospital at home compared with
intrahospital care. In: Cochrane Collaboration,ed. Cochrane Library. Issue
3. Oxford: Update Software, 1998.
4.
Pfister DG. Oncology and high-tech home care. In: Arras J, ed. Bringing
hospital to home. Baltimore: Johns Hopkins University Press, 1996:65-78.
5.
Marks L. Home and hospital care: redrawing the boundaries. London: King's
Fund, 1992.
6.
Close P, Burkey E, Kazak A, Danz P, Lange B. A prospective controlled
evaluation of home chemotherapy for children with cancer. Pediatrics 1995;
95: 896-900 [Abstract]
<http://bmj.com/cgi/ijlink?linkType=ABST&journalCode=pediatrics&resid=95/6/8
96> .
7.
Mor V, Stalker MZ, Gralla R, Scher HI, Cimma C, Park D, et al. Day hospital
as an alternative to inpatient care for cancer patients: a random assignment
trial. J Clin Epidemiol 1988; 41: 771-785 [Medline]
<http://bmj.com/cgi/external_ref?access_num=3418366&link_type=MED> .
8.
Rischin D, White MA, Matthews JP, Toner GC, Watty K, Sulkowski AJ, et al. A
randomised crossover trial of chemotherapy in the home: patient preferences
and cost analysis. Med J Aust 2000; 173: 125-127 [Medline]
<http://bmj.com/cgi/external_ref?access_num=10979376&link_type=MED> .
9.
King MT, Hall J, Caleo S, Gurney HP, Harnet PR. Home or hospital? An
evaluation of the costs, preferences and outcomes of domiciliary
chemotherapy. Int J Health Serv 2000; 30: 557-579 [Medline]
<http://bmj.com/cgi/external_ref?access_num=11109181&link_type=MED> .
10.
WHO handbook for reporting results of cancer treatment. Neoplasma 1980; 20:
37-46.
11.
Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, et al. The
EORTC QOL-C30: a quality of life instrument for use in international
clinical trials in oncology. J Natl Cancer Inst 1993; 85: 365-376 [Abstract]
<http://bmj.com/cgi/ijlink?linkType=ABST&journalCode=jnci&resid=85/5/365> .
12.
Karnofsky DA, Buchenal JH. The clinical evaluation of chemotherapeutic
agents in cancer. In: Mackad CM, ed. Evaluation of chemotherapeutic agents.
New York: Columbia University Press, 1949.
13.
McCusker J. Development of scales to measure satisfaction and preferences
regarding long-term and terminal care. Med Care 1984; 22: 476-493 [Medline]
<http://bmj.com/cgi/external_ref?access_num=6425580&link_type=MED> .
14.
Cronbach LJ. Coefficient alpha and the internal structure of the tests.
Psychometrika 1951; 16: 297-334.
15.
Nunally JC, Bernstein IH. Psychometric theory. 3rd ed. New York:
McGraw-Hill, 1994.
16.
Payne SA. A study of quality of life in cancer patients receiving palliative
chemotherapy. Soc Sci Med 1992; 35: 1505-1509 [Medline]
<http://bmj.com/cgi/external_ref?access_num=1283035&link_type=MED> .
17.
Lewis C, Linet MS, Abeloff MD. Compliance with cancer therapy by patients
and physicians. Am J Med 1983; 74: 673-678 [Medline]
<http://bmj.com/cgi/external_ref?access_num=6837593&link_type=MED> .
18.
Green JA. Compliance and cancer chemotherapy. BMJ 1983; 287: 778-779
[Medline] <http://bmj.com/cgi/external_ref?access_num=6412825&link_type=MED>
.
19.
Barofsky I. Therapeutic compliance and the cancer patient. Health Educ Q
1984; 10(suppl): 43-56.
20.
Richardson JL, Martis G, Levine A. The influence of symptoms of disease and
side effects of treatment on compliance with cancer therapy. J Clin Oncol
1988; 6: 1746-1752 [Medline]
<http://bmj.com/cgi/external_ref?access_num=3183704&link_type=MED> .
21.
Lowenthal RM, Piaszczyk A, Arthur GE, O'Malley S. Home chemotherapy for
cancer patients: a cost analysis and safety. BMJ 1999; 319: 1547-1550
[Abstract/Full Text]
<http://bmj.com/cgi/ijlink?linkType=ABST&journalCode=bmj&resid=319/7224/1547
> .
22.
Smeenk F, van Haastregt J, de Witte LP, Crebolder H. Effectiveness of home
care programmes for patients with incurable cancer on their quality of life
and time spent in hospital: systematic review. BMJ 1998; 316: 1939-1944
[Abstract/Full Text]
<http://bmj.com/cgi/ijlink?linkType=ABST&journalCode=bmj&resid=316/7149/1939
> .
(Accepted 5 January 2001)


Edward E. Rylander, M.D.
D.A.B.F.P and D.A.B.P.M.