Copyright B 2017 Wolters Kluwer Health, Inc. All rights reserved.

Xiao Bin Lai, PhD

Shirley Siu Yin Ching, PhD
Frances Kam Yuet Wong, PhD
Carenx Wai Yee Leung, MBA
Lai Ha Lee, MN
Jessica Shuk Yin Wong, MN
Yim Fan Lo, MN

A Nurse-Led Care Program for Breast

Cancer Patients in a Chemotherapy Day
Center
A Randomized Controlled Trial

K E Y W O R D S Background: Healthcare providers are facing the challenge of helping cancer

Advanced practice nursing patients cope with the impact of outpatient-based chemotherapy. A nurse-led care
Chemotherapy program was proposed to address this challenge. Objective: The aim of this study
Nurse-led care was to examine the effects of a nurse-led care program for patients receiving
Oncology nursing outpatient-based chemotherapy. Methods: This was a single-center, open-label,
2-arm parallel trial with equal randomization (NCT02228200). Breast cancer
patients in Hong Kong were randomly allocated to the intervention arm or the control
arm. The control arm received routine hospital care. The intervention arm received
the nurse-led care plus the routine hospital care. The quality of life, self-efficacy,
symptom distress levels, and satisfaction with care were evaluated with
questionnaires before randomization (T0), in the middle of chemotherapy (T1), and
1 month after chemotherapy (T2). Individual interviews were conducted with some
participants in the intervention arm at T2. Results: The intervention arm
participants reported significantly lower distress levels from oral problems, fatigue,
peripheral neuropathy, distressful feelings, and higher satisfaction with care.
According to the satisfaction evaluation and the interviews, the participants stated
that the service was helpful in providing information and communication
opportunities, filling the service gap after drug administration, providing

Authors Affiliations: School of Nursing, Fudan University, Shanghai,
China (Dr Lai); and School of Nursing, The Hong Kong Polytechnic
University (Drs Lai, Ching, and Wong); and Department of Clinical
Oncology, Queen Elizabeth Hospital (Mss Leung, Lee, Wong, and Lo),
Hong Kong.
This study was supported by Central Research Grant from the Hong
Kong Polytechnic University (grant RU0Q). The authors that there has been
no significant financial support for this work that could have influenced its
outcome.
The authors have no conflicts of interest to disclose.
Correspondence: Xiao Bin Lai, PhD, School of Nursing, Fudan University,
305 Fenglin Road, Shanghai, China 200032 (xblai@fudan.edu.cn).
Accepted for publication July 14, 2017.
DOI: 10.1097/NCC.0000000000000539

Nurse-Led Care Program in Chemotherapy Day Center Cancer NursingTM, Vol. 00, No. 0, 2017 n 1

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 psychological support, relieving discomfort, and building confidence.
Conclusion: Breast cancer patients received support from the provision of
comprehensive, continuous, and individualized care. Implications for
Practice: The nurse-led care program could be applied to breast cancer patients in
other hospitals in Hong Kong. Exploring its applicability to cancer settings in other
countries is recommended.

C
ancer has become a major health problem in Hong Kong,
with the number of cases increasing at a rate of 2%
annually.1 Outpatient-based chemotherapy has been
used for more than 10 years in Hong Kong to meet the increasing
demand for chemotherapy service.2,3 The adverse effects associated
with chemotherapy can inflict great hardship on cancer patients
and lead to a series of negative consequences,4 causing patients to
feel that this period is difficult to cope with.5 The outpatient-
based chemotherapy may increase the level of difficulty with
coping because there is limited interaction between patients
and healthcare providers. In the face of a burgeoning need for
outpatient-based chemotherapy, healthcare professionals in
Hong Kong need to address the issue of how to improve the
quality of patient care during outpatient-based chemotherapy.
Nurse-led care is highly recommended6 for its effectiveness,
safety, and for the high patient satisfaction that results.7 Although
some reports on nurse-led cancer care exist, insufficient evidence
related to nurse-led care for cancer patients during outpatient-
based chemotherapy is avoidable.8Y12 Further research is required
to rigorously and creatively evaluate this care model among
cancer patients receiving outpatient-based chemotherapy.13
Study Purpose
The main purpose of the study was to evaluate the effects of
a nurse-led care program on the quality of life (QOL), self-
efficacy, distress levels associated with chemotherapy-related
symptoms, and satisfaction with care reports of cancer patients
receiving outpatient-based chemotherapy. Specifically, we hypoth-
esized that there would be no differences between the intervention
and control arms in QOL during chemotherapy. The secondary
objectives were to (i) compare the 2 arms for self-efficacy,
distress levels associated with chemotherapy-related symptoms,
and satisfaction with care and (ii) understand the impact of the
nurse-led care program on coping with chemotherapy from the
perspective of cancer patients.
Theoretical Framework
This study was developed based on Bridges"14 transition theory
and Meleis"15 transition theory (Figure 1). Undergoing chemo-
therapy was regarded as a treatment-related 3-phase transition.
The entry phase of this transition consists of a few days before
chemotherapy and 3 to 4weeks after the first cycle. The passage
phase refers to the period between the second cycle and the
penultimate cycle. The exit phase refers to the last cycle and the
following 3 or 4weeks. The success of the transition is decided
by the involvement of an individual, which can be affected by
personal factors, including awareness, engagement, meaning,
preparation and knowledge,15 and confidence.16 The nurse-led
care program was designed to target the personal factors that
affected the involvement of a patient in the chemotherapy-
related transition. Successful transitions will lead to (1) a subjective
sense of well-being, (2) the mastery of new behaviors, and (3) the
well-being of interpersonal relationships.15 The subjective sense of
well-being in the context of this study can be measured by QOL
and distress levels associated with chemotherapy-related symp-
toms. The mastery of new behaviors can be inferred by self-
efficacy, that is, the confidence of the patients in managing one"s
symptoms to maintain effort and reduce symptom distress during
the process of chemotherapy. These 2 aspects of the transition
were captured by questionnaires. The third aspect, the well-being
of interpersonal relationships in the transition theory, mainly
referred to the well-being of the family relationship. Because this
study was confined to individual well-being, the aspect of the
relationship of the patients with the family was not explored.
However, maintaining a therapeutic relationship between the
nurses and the patients is essential to make the transition passage
smooth. This will be reflected in the satisfaction with care
measured by a structured questionnaire.
n Methods
Design and Settings
This was a single-center, open-label, 2-arm parallel trial with
equal randomization (1:1), conducted in the chemotherapy
day center of an acute care hospital in Hong Kong.
Sample
The inclusion criteria were (a) being at least 18 years old, (b)
having a diagnosis of primary breast cancer, (c) receiving
adjuvant chemotherapy for the first time, (d ) Karnofsky
Performance Scale score of at least 60, (e) being able to
communicate in Cantonese and read Chinese, and (f ) being
available to be contacted by telephone. The exclusion criteria were
(a) having a history of psychiatric or intellectual impairment, (b)
having previously received chemotherapy, or (c) having metas-
tasis or being at the end stage of life. A participant could be
withdrawn from the study if her chemotherapy regimen was
changed because of the disease progress. Breast cancer patients
were chosen for the study because breast cancer is one of the
most common cancers in Hong Kong.17 The majority of

2 n Cancer NursingTM, Vol. 00, No. 0, 2017 Lai et al

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Figure 1 n Theoretical framework of the study.
breast cancer patients received chemotherapy in chemotherapy
day centers.
The sample size was calculated aiming to differentiate the
between-arms effects in the primary outcome (QOL) assessed using
the Functional Assessment of Cancer TherapyYGeneral (FACT-
G). A meaningful difference is defined as a 5-point difference in the
FACT-G total score.18 The SD for the FACT-G total score for
the cancer sample was 17.18 The effect size ( f ) with a 5-point
difference for the study was 0.29 (5/17). Forty-five participants
were needed for each arm to achieve the power (1j ") of .80
with the significance criterion (!) of .05. Assuming an 80%
recruitment rate and a 10% attrition rate, a total of 126 patients
were needed for the 2 arms (63 patients per arm).
Patient recruitment and group assignment were conducted
by one of the researchers (X.B.L.), who screened medical records
to identify eligible patients and invited them to join the study.
Participants were first stratified according to their treatment
plans (Figure 2); that is, those participants who received 4-
cycle chemotherapy were assigned to group A, and those who
received 6-cycle chemotherapy were assigned to group B. Two
random allocation sequences for the 2 groups were generated
using an online randomization generator with a 1:1 allocation
using a block size of 4. The allocation sequence was packaged
in sequentially numbered, sealed, and opaque envelopes. The
generation of random allocation sequences and packaging of
the allocation sequences were conducted before the commence-
ment of the study by a third party. After the patients joined
the study, the researcher opened the envelopes and randomly
assigned each to the intervention or control arm and notified
the participant of the allocation. Next, the researcher notified
the intervention nurses regarding participants assigned to the
intervention arm only. Participants assigned to the control
arm were concealed from the intervention nurses to ensure
that they would provide these individuals with the same care
as that given to the other patients in the chemotherapy day
center.
Before the commencement of study, ethical approval was
obtained from the ethics committees of the university and the
study hospital (KC/KE-12-0002/ER-5). Eligible patients were
invited in person after being given an introduction of the study.
All of the participants signed the consent forms.
Nurse-Led Care Program in Chemotherapy Day Center
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Interventions
Two types of interventions were delivered in the study (ie, the
routine hospital care and the nurse-led care). Participants in the
control arm received the routine hospital care, and participants
in the intervention arm received both the nurse-led care and the
routine hospital care. The routine hospital care included a brief
education session before chemotherapy, care on the days of drug
administration, and access to a patient-initiated hotline service
during chemotherapy.
The nurse-led care has previously been introduced in detail.19
Briefly, it consisted of a prechemotherapy nurse consultation
and nurse-led telephone follow-up during chemotherapy, tar-
geting the personal factors in the theoretical framework. The
prechemotherapy nurse consultation was conducted on the day
of the first cycle and before the drug administration. The nurse-
led telephone follow-up contacts were delivered within 1week
after the first, second, fourth, and sixth cycles (Figure 2), which
were dependent on the participant"s chemotherapy protocol;
that is, those undergoing 4-cycle chemotherapy received the
telephone follow-ups after the first, second, and fourth cycles,
and those undergoing 6-cycle chemotherapy received the
telephone follow-ups after the first, second, fourth, and sixth
cycles.
The nurse-led care was delivered by 3 intervention nurses
according to evidence-based practice protocols following the care
procedure designed for the study.19 The eligibility criteria for the
intervention nurses were (i) having a high diploma degree in
nursing or higher degree and (ii) having more than 5 years of
working experience in oncology settings. The intervention nurses
were 3 nurses who had worked in the oncology department for 10
to 17years.
The intervention fidelity was evaluated with an inter-
vention fidelity checklist, which was modified based on the
checklist used in an interventional study.20 Nearly all of the
intervention sessions (89.7%) were recorded with digital re-
corders. Ten percent of the recorded intervention sessions were
randomly selected to evaluate the intervention fidelity. One
researcher (X.B.L.) listened to the selected records. The nurs-
ing care in each session was compared with the items in the
checklist.
Cancer NursingTM, Vol. 00, No. 0, 2017 n 3
Figure 2 n Flowchart of the study.
Instruments
The effects of the nurse-led care were evaluated using both
quantitative and qualitative methods. Data collection was carried
out at 3 time points: before randomization (T0), before the middle
cycle of chemotherapy (T1), and 1month after the completion of
chemotherapy (T2) (Figure 2).
The study questionnaires were introduced previously.19
Quality of life (T0, T1, T2), as an indicator of the subjective
sense of well-being, was the primary outcome assessed using
FACT-G.21 Twenty-seven items comprise the questionnaire and
are classified into 4 subscales: the physical, emotional, social, and
functional well-being. Each item was rated on a scale of 1 to 4.
Each subscale had a total score; the total score of the entire
4 n Cancer NursingTM, Vol. 00, No. 0, 2017
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questionnaire was the sum of the scores for the 4 subscales. A
higher score represented better QOL. The Cronbach"s ! of the
Chinese version was .85.22
Self-efficacy (T0, T1, T2) was assessed using the 29-item
Strategies Used by People to Promote Health (SUPPH)23 to
reflect changes in participants" confidence. It included 2 factors:
the physiological factor and the performance factor.24 Each
item was rated on a scale of 1 to 5. The total score of the SUPPH
was the sum of the scores for all items. A higher score rep-
resented higher self-efficacy. The Cronbach"s ! of the Chinese
version was .97.25
The distress levels associated with chemotherapy-related symp-
toms (T1, T2) were assessed using the Chemotherapy Symptom
Lai et al
Figure 3 n Flowchart of the participant enrollment and follow-up.
Assessment Scale (CSAS).26 The symptom distress levels were
indicators of the subjective sense of well-being. Twenty-two
chemotherapy-related symptoms were assessed in the CSAS. If a
symptom was present, then the distress level associated with the
symptom would be rated on a scale of 0 to 3 (0=not at all; 3=very
much). The Cronbach"s ! of the English version was .82.27
The satisfaction with care (T2) was evaluated with a self-
designed questionnaire. There were 2 versions for this ques-
tionnaire of satisfaction with care: one for the intervention
arm and the other one for the control arm. Twenty-two items in
the 2 versions were the same, including (i) a scale from 0 to 10
scores to evaluate the overall satisfaction with care (0 = totally
Nurse-Led Care Program in Chemotherapy Day Center
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dissatisfied, 10=totally satisfied); (ii) 13 items to evaluate the 2
types of intervention sessions before chemotherapy, that is,
brief education and prechemotherapy nurse consultation; (iii)
8 items to evaluate the 2 types of intervention sessions during
chemotherapy, that is, hotline service and nurse-led telephone
follow-up. The 21 items in parts 2 and 3 were rated on a scale of
1 to 5 (1=totally disagree; 5=totally agree). Besides the same 22
items, there were 9 items in the version for the intervention arm.
These 9 items were particularly designed to evaluate the nurse-
led telephone follow-up.
Individual interviews with some participants in the interven-
tion arm were conducted at T2 to understand the impact of the
Cancer NursingTM, Vol. 00, No. 0, 2017 n 5
nurse-led care program from their perspective. Purposive
sampling was used so that participants receiving different
chemotherapy schemes were invited. The following questions
were raised in the interviews: (i) What did the nurse tell you in
the prechemotherapy nurse consultation? (ii) Was the conver-
sation helpful? (iii) How did it help you? (iv) What did the nurse
tell you during the telephone follow-ups? (v) Were the
telephone calls helpful? (vi) How did they help you?
Data Collection
All of the questionnaires were self-administered. The T0 ques-
tionnaires were completed at home. The T1 and T2 question-
naires were completed in the waiting room of the oncology
outpatient clinic. The individual interviews were conducted in a
quiet consultation room in the hospital after the participants
had completed the T2 questionnaires.
Data Analysis
The IBM SPSS 19.0 (IBM Corp, Armonk, New York) was
used for managing and analyzing the quantitative data. The
intention-to-treat principle was carried out. The missing data
in the QOL and self-efficacy were handled with the statistical
model Expectation Maximization algorithm. The rationale
for using Expectation Maximization was less bias caused by a
modeling approach than an imputation approach.28 In terms
of the distress levels associated with chemotherapy-related
symptoms, 2 methods were adopted to replace the missing data
in the frequencies of symptoms and the distress levels associated
with the symptoms: (i) using 0 to replace the missing responses
about the presence and distress level of a symptom at T1, which
represented that the participant had not experienced the symptom
and hence the distress caused by it; and (ii) the missing data about
the presence and the distress level of a symptom at T2: the last-
observation-carried-forward method was used.
The data of the QOL, distress levels associated with the
symptoms, self-efficacy, and satisfaction with care were analyzed
quantitatively. All variables were first presented with appropriate
descriptive statistics. The comparisons between the intervention
arm and the control arm with regard to QOL and self-efficacy
over time were performed using the repeated-measures analysis of
variance (ANOVA) and the independent-sample t test. The post
hoc comparison was conducted when the change over time was
statistically significant. Bonferroni correction was used to control
type I error. The pairwise ! for the post hoc comparisons was
.017 (0.05/3). The distress levels associated with the symptoms
and the satisfaction with care were compared using the Mann-
Whitney U test.
The interviews were analyzed qualitatively. All of the in-
terviews were transcribed verbatim in Chinese. The transcripts
were imported into the qualitative analysis software, Nvivo 8.0
(QSR International Pty Ltd, Melbourne, Australia) for data
management. The content analysis method proposed by
Graneheim and Lundman29 was used to analyze the interviews.
It included (i) reading the interview transcribed verbatim several
6 n Cancer NursingTM, Vol. 00, No. 0, 2017
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times to get an overall sense of the content, (ii) dividing the text
into content areas according to the interview guide, (iii) extract-
ing meaning units within each content area and then condensing,
(iv) labeling of codes that were abstracted from the condensed
meaning units, and (v) sorting of codes into subcategories after
comparing the differences and similarities. Two methods were
used to ensure the credibility of the qualitative analysis. The first
method was prolonged engagement. The implementation of the
main study lasted 12 years. The qualitative data were collected
from the middle phase of the study implementation when the
researcher was familiar with the treatment setting and procedure
and the experience of cancer patients receiving chemotherapy.
The second method was that the initial codes were done
independently by 2 of the researchers (X.B.L. and S.S.Y.C.).
X.B.L. and S.S.Y.C. met to compare the codes, and the discrep-
ancy was discussed with the final code arrived at by consensus.
n Results
Participants
Participants were recruited from June 2012 to September 2013.
In total, 399 medical records were reviewed (Figure 3). One
hundred twenty-four eligible patients (31.1%) took part in the
study; 60 were in the intervention arm, and 64 in the control
arm. The overall dropout rate was 6.5% (n=8). Finally, the data
of 120 participants, that is, 62 from the control arm and 58
from the intervention arm, were included in the data analysis.
The demographic and clinical characteristics of the study sample
actually analyzed (n=120) are listed in Table 1.
Summary of the Delivery of Nurse-Led Care
Three intervention nurses delivered 271 intervention sessions in
total. The intervention fidelity was 84% for the prechemotherapy
nurse consultation and 88% for the nurse-led telephone follow-
ups. The mean duration of the prechemotherapy nurse consul-
tations, scheduled telephone follow-ups, and extra telephone
follow-ups was 37.30 (SD, 8.48) minutes, 17.16 (SD, 9.02)
minutes, and 13.20 (SD, 5.83) minutes, respectively.
Quality of Life and Self-efficacy
No significant differences were found between the interven-
tion arm and the control arm in the scores of QOL and self-
efficacy over time (Tables 2 and 3). Similarly, when the scores
of those in the 2 arms at each time point were compared, no
significant differences were found.
Distress Levels Associated With Symptoms
Twenty-two chemotherapy-related symptoms were assessed in
the study. Two symptoms, that is, changes in intimate or
sexual relationship and changes in menopausal periods,
were excluded from the data analysis because of low response
rates. The most common symptoms during chemotherapy were
hair loss (91.7%Y98.3%), fatigue (94.2%Y95.0%), skin/nail
Lai et al
 Table 1 & Demographic and Clinical Data of the Participants
Variables Total (n = 120) Control (n = 62) Intervention (n = 58)
Age, mean (SD), y 51.13 (9.02) 50.58 (9.25) 51.55 (8.82)
n (%) n (%) n (%)
Education background
Primary school 21 (17.5) 8 (12.9) 13 (22.4)
Secondary school 82 (68.3) 43 (69.4) 39 (67.3)
Tertiary school 17 (14.2) 11 (17.7) 6 (10.3)
Marital status
Single/divorced/widowed 28 (23.3) 15 (24.2) 13 (22.4)
Married/cohabiting 92 (76.7) 47 (75.8) 45 (77.6)
Religion
None 62 (51.7) 27 (43.5) 35 (60.3)
Buddhist/Taoist 27 (22.5) 15 (24.2) 12 (20.7)
Catholic/Christian 31 (25.8) 20 (32.3) 11 (19.0)
Living arrangement
Alone 9 (7.5) 4 (6.5) 5 (8.6)
With 1 member 34 (28.3) 18 (29.0) 16 (27.6)
With 2 members 26 (21.7) 15 (24.2) 11 (19.0)
With Q3 members 51 (42.5) 25 (40.3) 26 (44.8)
Primary caregiver
Self 33 (27.5) 17 (27.4) 16 (27.6)
Family member 87 (72.5) 45 (72.6) 42 (72.4)
Prediagnosis employment
Full-time job/part-time job 78 (65.0) 39 (62.9) 39 (67.2)
Staying at home/sick leave 42 (35.0) 23 (37.1) 19 (32.8)
Employment during treatment
Full-time job/part-time job 25 (20.8) 15 (24.2) 10 (17.2)
Staying at home/sick leave 95 (79.2) 47 (75.8) 48 (82.8)
Monthly family income, HK$
G 9999 21 (17.5) 11 (17.7) 10 (17.2)
10 000Y19 999 38 (31.7) 23 (37.1) 15 (25.9)
20,000Y29,999 27 (22.5) 14 (22.6) 13 (22.4)
Q 30,000 25 (20.8) 13 (21.0) 12 (20.7)
Missing 9 (7.5) 1 (1.6) 8 (13.8)
Payment of drug expenses
Government subsidy 35 (29.2) 15 (24.2) 20 (34.5)
Medicare coverage 17 (14.2) 10 (16.1) 7 (12.0)
Self-financed 63 (52.5) 35 (56.5) 28 (48.3)
Missing 5 (4.1) 2 (3.2) 3 (5.2)
Difficulty in making payment
No 54 (45.0) 25 (40.3) 29 (50.0)
Yes 63 (52.5) 37 (59.7) 26 (44.8)
Missing 3 (2.5) 3 (5.2)
Karnofsky Performance Scale score, median (range) 90 (70Y90) 90 (70Y90) 90 (70Y90)
BMI, mean (SD), kg/m2 23.69 (4.19) 23.98 (4.14) 23.38 (4.24)
Disease stage
I 35 (29.2) 18 (29.0) 17 (29.3)
II 65 (54.1) 32 (51.6) 33 (56.9)
III 20 (16.7) 12 (19.4) 8 (13.8)
Health history
None 85 (70.8) 42 (67.8) 43 (74.1)
91 Chronic condition 18 (15.0) 10 (16.1) 8 (13.8)
Q 2 Chronic conditions 17 (14.2) 10 (16.1) 7 (12.1)

changes (83.3%Y91.7%), appetite changes (80.0%Y81.7%), mouth/throat problems at T1, fatigue at T2, numbness on
mouth/throat problems (T1: 78.3%), and pain (T2: 80.8%). hand/feet at T1, and distressful feelings at T2, were significantly
The distress levels associated with the 4 symptoms, including lower in the intervention arm than in the control arm (Table 4).

Nurse-Led Care Program in Chemotherapy Day Center Cancer NursingTM, Vol. 00, No. 0, 2017 n 7

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 Table 2 & Results on Quality of Life
T0 T1 T2 Within Arma Arm Difference at T2
a b a
Item n Mean (SD) Mean (SD) Mean (SD) Between Arms [(T1 vs T0) (T2 vs T1) (T2 vs T0)] Interaction (95% Confidence Interval)

8 n Cancer NursingTM, Vol. 00, No. 0, 2017

Overall quality of life
Control 62 74.07 (12.17) 71.41 (14.10) 71.79 (15.73) (.026) (.872) (4.504) (.014) (.253) (.763) 1.26 (j4.35 to 6.87)
Intervention 58 74.23 (12.34) 71.45 (13.61) 70.53 (15.29) (1.854) (.167)
Between armsc (j.070) (.944) (j.014) (.989) (.445) (.657) (2.808) (.064)
Physical well-being (25.071) (G0.001)
Control 62 21.59 (4.46) 18.29 (5.36) 18.73 (6.22) (.367) (.546) (12.398) (G0.001) [(G0.001) (9.999) (.001)] (.993) (.372) 0.32 (j1.83 to 2.48)
Intervention 58 22.12 (4.09) 19.41 (4.70) 18.41 (5.68) (13.661) (G0.001) [(.001) (.526) (G.001)]
Between armsc (j.674) (.502) (j1.213) (.227) (.297) (.767)
Social well-being (.700) (.484)
Control 62 20.71 (6.00) 20.02 (5.26) 20.16 (5.04) (.712) (.400) (.071) (.916) 0.73 (j1.16 to 2.62)
Intervention 58 19.91 (5.57) 19.58 (4.37) 19.43 (5.43)
Between armsc (.753) (.453) (.497) (.620) (.764) (.447)
Emotional well-being (12.477) (G0.001)
Control 62 16.51 (4.33) 17.92 (4.61) 17.76 (4.48) (.007) (.934) (5.431) (.006) [(.023) (9.999) (.041)] (.360) (.681) j0.28 (j1.78 to 1.23)
Intervention 58 16.21 (4.21) 17.78 (4.31) 18.04 (3.80) (7.156) (.001) [(.026) (9.999) (.004)]
Between armsc (.384) (.702) (.175) (.862) (j.362) (.718)
Functional well-being
Control 62 15.26 (4.68) 15.23 (4.57) 15.07 (5.73) (.001) (.979) (1.725) (.185) (1.162) (.310) 0.37 (j1.57 to 2.31)
Intervention 58 15.99 (4.04) 14.81 (4.98) 14.70 (4.98)
Between armsc (j.907) (.366) (.475) (.636) (.376) (.708)
a
The comparison between the 2 arms over time and the comparison within each arm over time were conducted using ANOVA.
b
A post hoc comparison was conducted when the change over time was statistically significant. Only the P value of the post hoc comparison is listed in the table. The pairwise ! for the post hoc comparisons was .017 (0.05/3).
c
The comparison of the 2 arms at each time point was conducted using an independent-sample t test. The results of the statistical tests are presented as (statistic value) (P).

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Lai et al
 A post hoc comparison was conducted when the change over time was statistically significant. Only the P value of the post hoc comparison is listed in the table. The pairwise ! for the post hoc comparisons was .017 (0.05/3).
Satisfaction With Care

(95% Confidence Interval)

3.38 (j4.91 to 11.67)

Arm Difference at T2

2.38 (j3.93 to 8.70)

0.99 (j1.09 to 3.08)

The overall satisfaction with the care that the participants in the
intervention arm reported (median, 9) was significantly higher
than that reported by control arm participants (median, 7)
(U = 873.000, P G .001). The satisfaction with 2 types of
prechemotherapy sessions was compared: brief education for
the control arm and prechemotherapy nurse consultation for
the intervention arm (Table 5). The proportion of the
agreement of each item included those who chose agree or
(.020) (.967)

(.011) (.982)

(.002) (.996)
totally agree with the item. The proportion of those in
a
Interaction

agreement with the 13 items of the prechemotherapy nurse

The comparison of the 2 arms at each time-point was conducted using an independent-sample t test. The results of the statistical tests are presented as (statistic value) (P).
consultation was significantly higher than the proportion of
those in agreement with the brief education.
The items relating to the prechemotherapy nurse consulta-
(3.838) (.029) [(.091) (9.999) (.086)]
(3.702) (.039) [(.045) (9.999) (.169)]

(3.963) (.021) [(.073) (9.999) (.082)]

(3.491) (.046) [(.043) (9.999) (.214)]

(3.581) (.036) [(.177) (9.999) (.082)]

(3.579) (.039) [(.118) (9.999) (.114)]
b

tion that participants agreed with the most were (6) the nurse
[(T1 vs T0) (T2 vs T1) (T2 vs T0)]

introduced the possible adverse effects and care strategiesI

(98.1%), (2) the timing to meet the nurse was appropriate
(.7.429) (.001)
(7.533) (.001)

(7.153) (.001)
Within Arma

(88.9%), (13) I had the confidence to cope with the chemother-

apy and adverse effectsI (88.9%), (7) the nurse provided
suggestions on lifestyle management to cope with the adverse
effects (87.0%), (8) I had opportunities to raise my concerns
(87.0%), and (9) the nurse listened to my concerns carefully
The comparison between the 2 arms over time and the comparison within each arm over time were conducted using ANOVA.

(87.0%). Compared with the agreement with the brief education,

3 items showed the biggest increases: (10) the nurse provided
suggestions on my discomforts (48.6%), (7) the nurse provided
suggestions on lifestyle management to cope with the adverse
a

(1.362) (.246)
Between Arms

(.901) (.344)

(.718) (.399)

effects (47.9%), and (12) the nurse helped me to resolve

nonYtreatment-related questions and concerns (44.1%).
Two types of telephone service were evaluated: the hotline
service and the nurse-led telephone follow-up. Thirty-two
(50.8%) in the control arm had dialed the hotline; the telephone
90.76 (21.90)
87.39 (23.96)

69.29 (16.71)
66.91 (18.24)

calls from 26 participants (41.3%) were answered. The satisfac-

(.807) (.421)

(.747) (.456)

(.943) (.348)
21.47 (5.55)
20.47 (6.00)
Mean (SD)

tion with the nurse-led telephone follow-up was significantly

T2

higher than that with the hotline service (Table 5).

The items relating to the nurse-led telephone follow-up that
the respondents agreed with the most were (21) I had more
(1.015) (.312)
90.07 (20.58)
87.17 (21.02)

69.02 (15.94)
67.00 (15.96)

confidence to cope withI (94.4%), (17) I had opportunities

(.763) (.447)

(.695) (.488)

21.14 (5.09)
20.17 (5.34)
Mean (SD)

to raise questions and concerns (92.6%), and (16) the nurse

T1

provided suggestions on lifestyle managementI (87.0%).

The items with the biggest increases were (21) I had more
confidenceI (55.9%), (18) my discomforts were relieved
Table 3 & Results on Self-efficacy

(1.053) (.294)

after I tried the suggestions (48.8%), and (20) the nurse helped
85.18 (19.31)
81.67 (21.53)

65.03 (14.79)
62.79 (16.35)
(.940) (.349)

(.790) (.431)

19.90 (5.11)
18.88 (5.51)
Mean (SD)

me to resolve nonYtreatment-related questions (44.8%).

T0

The Qualitative Results

Ten participants in the intervention arm were interviewed to
62
58

62
58

62
58
n

understand the effects of the nurse-led care during their journey

Physiological efficacy

Performance efficacy
Between armsc

Between armsc

Between armsc

of undergoing chemotherapy. Four themes emerged from the

Total self-efficacy

interview data.
Intervention

Intervention

Intervention
Control

Control

Control

PROVIDING USEFUL INFORMATION

Item

The provision of information was the most important effect of

the nurse-led care throughout chemotherapy. Obtaining useful
b
a

Nurse-Led Care Program in Chemotherapy Day Center Cancer NursingTM, Vol. 00, No. 0, 2017 n 9

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 Table 4 & Distress Levels From Symptoms (n [%])
Item n Not at All A Bit Quite a Bit Very Much Between Armsa
Mouth/throat problems (T1)
Control 51 2 (3.9) 22 (43.1) 21 (41.2) 6 (11.8) (802.500) (.012)
Intervention 43 1 (2.3) 32 (74.4) 7 (16.3) 3 (7.0)
Fatigue (T2)
Control 58 2 (3.4) 16 (27.6) 20 (34.5) 20 (34.5) (1218.000) (.022)
Intervention 55 2 (3.6) 26 (47.3) 17 (30.9) 10 (18.2)
Numbness on hands/feet (T1)
Control 42 1 (2.4) 28 (66.6) 12 (28.6) 1 (2.4) (445.500) (.022)
Intervention 28 1 (3.6) 25 (89.3) 2 (7.1) 0 (0)
Distressful feelings (T2)
Control 32 0 (0) 15 (46.9) 9 (28.1) 8 (25.0) (454.500) (.027)
Intervention 29 1 (2.6) 26 (66.6) 9 (23.1) 3 (7.7)
a
The comparison between the 2 arms was conducted using the Mann-Whitney U test. The results of the statistical tests are presented as (statistic value) (P).

information, especially on coping strategies for adverse effects,
from the prechemotherapy nurse consultation was one benefit
frequently mentioned by the participants, which allowed them
to better prepare themselves physically and psychologically to
undergo chemotherapy. One participant commented, I could
know moreI My preparation was better (participant 38).
During the nurse-led telephone follow-up contacts, the partic-
ipants continued getting useful knowledge on how to cope. One
thought that the suggestion on self-monitoring of diarrhea had
helped her: She told me how to observe the condition and
when to see a doctor over the telephone. It was goodI
(participant 115).
FILLING THE SERVICE GAP AFTER THE ADMINISTRATION OF
DRUGS
Filling the service gap was another benefit mentioned by most
participants. They usually had many queries when they were at
home. However, they might have had difficulties getting
answers. The telephone follow-up was able to exactly meet their
needs at that moment. One said, We couldn"t get enough
information from the doctors. They were busy. And we met
different doctors in each consultation. When you suddenly had
a problem at home, you had no way to ask. However, you could
raise questions and get professional replies if the nurse called you
at that time (participant 58).
The nurses" calls could correct their wrong practices as well.
A participant expressed appreciation that the nurse stopped
her from practicing wrong self-care behavior: Once I
mentioned that I was drinking grapefruit juice. The nurse sug-
gested another kind of juice and explained the reason for this
(participant 54).
PROVIDING PSYCHOLOGICAL SUPPORT
The nurse-led care also provided psychological support to
the participants. It made them feel that the healthcare pro-
viders cared about them. One stated, It was like a channel
between me and the hospital. The nurses cared about me and
supported me all the time. They didn"t just give me the drugs
(participant 38).
This service also provided opportunities for participants to
share their experiences. Compared with family members and
friends, the nurses could understand them better. One men-
tioned, The nurses have cared for many patients like me. They
can understand and feel in the same way. That is what my family
and friends can"t do (participant 121).
Another psychological benefit was relieving nervousness and
uncertainty. The information provided by the nurses enabled the
participants to know what would happen during the chemother-
apy, what they could do for the adverse effects, and when and how
they could get medical advice. The information was valuable in
helping them to cope with the chemotherapy. One summarized,
The best thing about the service was that it made me feel
relieved. I knew how to prevent and handle it (the adverse
effects) (participant 50).
RELIEVING DISCOMFORT AND BUILDING UP CONFIDENCE
According to the interviews, the nurses" suggestions also helped
them to relieve discomfort from chemotherapy. One participant
with diarrhea thought that the nurse"s suggestion was useful. I
ate bananas for the diarrhea, as the nurse suggestedI It helped
(participant 115). Another participant thought that the nurse-
led service helped to build up her confidence. The most helpful
thing was helping me to gain confidence. It lets me know what I
can do when I experience adverse effects (participant 50).
n Discussion
According to the Census and Statistics Department of the
Government of the Hong Kong Special Administrative Re-
gion,30 the gross national income per capita was approximately
HK$24071 per month in 2012; the distribution of educa-
tional attainment was 71.9% at or above the secondary school
level. A comparison with these statistics suggests that the study
participants were middle-aged women from the lower socio-
economic class of Hong Kong. Clinically, they were diagnosed
as having stage I to stage III breast cancer and received adjuvant
chemotherapy. The prediagnostic health of most participants
was relatively good.

10 n Cancer NursingTM, Vol. 00, No. 0, 2017 Lai et al

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 Table 5 & Results on the Satisfaction With Care
Totally Disagree/ Not Sure, Agree/Totally
Items Types n Disagree, n (%) n (%) Agree, n (%) Between Armsa
Prechemotherapy Intervention Sessions
1. It was helpful to meet with the nurse Controlb 41 3 (7.3) 14 (34.1) 24 (58.6) (1073.000) (.002)
Interventionc 54 0 (0) 8 (14.8) 46 (85.2)
2. The timing to meet the nurse was Control 41 9 (22.0) 9 (22.0) 23 (56.0) (946.000) (G.001)
appropriate Intervention 54 0 (0) 6 (11.1) 48 (88.9)
3. The duration of the visit was appropriate Control 41 13 (31.7) 13 (31.7) 15 (36.6) (946.000) (G.001)
Intervention 54 2 (3.7) 11 (20.4) 41 (75.9)
4. The nurse knew my condition when Control 41 9 (22.0) 10 (24.4) 22 (53.6) (1135.000) (.006)
we met Intervention 54 2 (3.7) 9 (16.7) 43 (79.6)
5. The nurse explained the reason and Control 41 5 (12.2) 9 (22.0) 27 (65.8) (1215.000) (.022)
arrangements for the chemotherapy Intervention 54 0 (0) 9 (16.7) 45 (83.3)
6. The nurse introduced the possible Control 41 5 (12.2) 9 (22.0) 27 (65.8) (1032.500) (.001)
adverse effects and care strategies of Intervention 54 0 (0) 1 (1.9) 53 (98.1)
the treatment
7. The nurse provided suggestions on Control 41 10 (24.4) 15 (36.6) 16 (39.1) (896.000) (G.001)
lifestyle management to cope with the Intervention 54 0 (0) 7 (13.0) 47 (87.0)
adverse effects
8. I had opportunities to raise questions Control 41 9 (22.0) 11 (26.8) 21 (51.2) (956.500) (G.001)
and concerns Intervention 54 2 (3.7) 5 (9.3) 47 (87.0)
9. The nurse listened to my concerns Control 41 9 (22.0) 14 (34.1) 28 (43.9) (866.500) (G.001)
carefully Intervention 54 2 (3.7) 5 (9.3) 47 (87.0)
10. The nurse provided suggestions on my Control 41 13 (31.7) 13 (31.7) 15 (36.6) (707.000) (G.001)
discomforts (eg, constipation, pain) Intervention 54 0 (0) 8 (14.8) 46 (85.2)
11. Meeting with the nurse relieved the Control 41 7 (17.0) 15 (36.6) 19 (46.4) (969.000) (G.001)
stress of the chemotherapy Intervention 54 0 (0) 10 (18.5) 44 (81.5)
12. The nurse helped me to resolve other Control 41 14 (34.1) 14 (34.1) 13 (31.8) (932.000) (G.001)
nonYtreatment-related questions and Intervention 54 2 (3.7) 11 (20.4) 41 (75.9)
concerns
13. I had the confidence to cope with the Control 41 6 (14.6) 14 (34.1) 21 (51.3) (936.000) (G.001)
chemotherapy and adverse effects after Intervention 54 0 (0) 6 (11.1) 48 (88.9)
meeting with the nurse
Telephone Servicesd
14. The telephone service during the Intervention 54 0 (0) 6 (11.1) 48 (88.9) (473.500) (.011)
chemotherapy was helpful for me Intervention 54 0 (0) 7 (13.0) 47 (87.0)
15. The duration of each telephone call Control 26 3 (11.5) 9 (34.9) 14 (53.9) (351.500) (G.001)
was appropriate Intervention 54 0 (0) 9 (16.7) 45 (83.3)
16. The nurse provided suggestions on life Control 26 9 (34.6) 8 (30.8) 9 (34.6) (200.000) (G.001)
management to cope with the adverse Intervention 54 0 (0) 7 (13.0) 47 (87.0)
effects
17. I had opportunities to raise questions Control 26 5 (19.2) 6 (23.1) 15 (57.7) (297.000) (G.001)
and concerns on the telephone Intervention 54 0 (0) 4 (7.4) 50 (92.6)
18. My discomforts were relieved after I Control 26 9 (34.6) 9 (34.6) 8 (30.8) (263.000) (G.001)
tried the suggestions provided by the Intervention 54 0 (0) 11 (20.4) 43 (79.6)
nurse
19. Talking with the nurse on the Control 26 7 (26.9) 7 (26.9) 12 (46.2) (331.000) (G.001)
telephone relieved my stress from the Intervention 54 0 (0) 8 (14.8) 46 (85.2)
chemotherapy
20. The nurse helped me to resolve other Control 26 10 (38.5) 6 (23.0) 10 (38.5) (299.000) (G.001)
nonYtreatment-related questions and Intervention 54 3 (5.6) 6 (11.1) 45 (83.3)
concerns
21. I had more confidence to cope with Control 26 7 (27.0) 9 (61.5) 10 (38.5) (275.000) (G.001)
the adverse effects and complete the Intervention 54 0 (0) 3 (5.6) 51 (94.4)
treatment
a
The comparison between the 2 arms was conducted using the Mann-Whitney U test. The statistical results are presented as (statistic value) (P).
b
The evaluation from 18 participants in the control arm was not included in the data analysis because of inaccurate evaluations.
c
Four participants in the intervention arm did not complete the satisfaction questionnaire.
d
Only the telephone calls from 26 participants in the control arm were answered by the nurses.

Nurse-Led Care Program in Chemotherapy Day Center Cancer NursingTM, Vol. 00, No. 0, 2017 n 11

Copyright 2017 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
The Effects of the Nurse-Led Care Program
The quantitative and qualitative findings of the study revealed
an interesting picture. In terms of the quantitative evaluation,
nonsignificant differences were found between the 2 arms in
their QOL, self-efficacy, and distress levels of most symp-
toms, whereas participants in the intervention arm reported
significantly lower distress levels associated with oral prob-
lems, fatigue, peripheral neuropathy, and distressful feelings
and significantly higher satisfaction with care. In terms of the
qualitative exploration, the interviews suggested that the nurse-
led care had several effects. Reviewing the findings from the 2
aspects, the nurse-led care program may benefit the patients in
that it provides continuous, comprehensive, and individualized
care, including providing information and opportunities to raise
concerns, providing psychological support, relieving discomfort,
improving confidence, and helping to resolve nonYtreatment-
related issues during the entire course of the chemotherapy.
Comparisons with previous evidence are limited because there
have been only a few multicomponent intervention studies
focusing on patients during outpatient-based chemotherapy. The
finding of a similar QOL between the 2 arms in the study was in
agreement with other multicomponent intervention studies.11,12,31
The value in providing information and psychological support
was echoed by previous studies.11,32,33 Higher satisfaction was
likewise found previously.8Y10 In terms of chemotherapy-related
symptoms, the patients reported less toxicity in more symptoms
in 2 studies,8,12 whereas a similar level of distress was reported in
another study.11 It was difficult to compare the results on self-
efficacy, because studies examining the impact of nurse-led care
on the self-efficacy of cancer patients receiving outpatient-based
chemotherapy are lacking.
In general, most of the evidence is encouraging, indicating that
nurse-led care for cancer patients receiving outpatient chemo-
therapy is beneficial in some aspects, including in providing
information and psychological support, managing adverse
effects, and improving satisfaction with care. Yet, because of
the complexity of nurse-led care, more research is needed to
provide more scientific evidence to demonstrate the effec-
tiveness of this care model.
Filling the Service Gaps: Continuous,
Comprehensive, and Individualized Care
Cancer patients receiving outpatient-based chemotherapy face
challenges in multiple domains. Numerous studies have reported
on their multiple needs during treatment.34Y36 However, all
of the challenges may not be fully resolved in the existing
healthcare system. Limited communication is a major problem
due to the increasing number of patients and shortage of human
resources. Outpatient-based chemotherapy further reduces the
support received from healthcare providers. The patients had
limited opportunities to discuss their problems or concerns with
healthcare providers.37 Facing their multiple needs, comprehen-
sive care that covers the entire course of chemotherapy is needed.
Information on treatment, adverse effects, and coping strate-
gies is commonly needed by cancer patients receiving active
12 n Cancer NursingTM, Vol. 00, No. 0, 2017
Copyright 2017 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
treamtent.34,35,38Y40 For Chinese cancer patients, the informa-
tion need is particularly high.38,41,42 Yet cancer patients were
not satisfied with the information provided by doctors.43,44
The nurse-led care program may help to fill this service gap.
The provision of information, which was a major benefit
found in the study, satisfied the information need of the cancer
patients. It also contributed to the high satisfaction with care.45
Another service gap was the continuous support during
the course of chemotherapy.46 More problems may arise after
patients are discharged from the hospital.47 This observation
is supported by the interviews in the study. A nurse-led
telephone follow-up at that time could help the patients when
they are at home. The nurses could correct inappropriate self-
care behaviors, clarify misunderstandings, and emphasize impor-
tant self-care tips. The patients felt that they were under the
protection of healthcare providers all along. It also reduced the
patients" nervousness and uncertainty. The findings in the study
indicate that the nurse-led telephone follow-up is helpful in
providing continuous support.
The provision of psychological support was designed to be
an important component of the nurse-led care. Although a sig-
nificant difference was found only in the symptom distressful
feelings at the completion of chemotherapy, the findings from
the interviews provided more rich data about how the patients
were supported psychologically under the nurse-led care. Relieving
the nervousness and uncertainty, being cared, and being under-
stood were valuable points appreciated by the participants. The
care experience made it possible for the nurses to better understand
the cancer patients.48 Although patients receiving routine hospital
care may also find nurses are psychologically supportive, because
of the busy work to administer chemotherapy drugs in the day
center, it is difficult for nurses to provide adequate psychological
support to cancer patients. In the nurse-led care, with more inter-
active time and comprehensive assessment, nurses could give better
psychological care using their good experience.
Individualized and holistic approach was a critical element of
the effectiveness of the nurse-led care program.48 With compre-
hensive assessment and abundant communication, the nurse can
identify the patient"s multiple needs and manage them properly.
Such individualized care was highly appreciated by the par-
ticipants. Three highly appreciated items of the nurse-led care
were having opportunities to raise questions, being listened to
carefully, and having nonYtreatment-related problems resolved.
The healthcare in the patients" cancer journey is fragmented and
complex.49 Patients feel confused and lost in the complex health-
care system because they are not familiar with all of the services/
resources available, and they do not get adequate guidance. In
this study, the nurses provided guidance and referral to the
participants in approaching the services that they needed. The
nurse-led care was like providing the patient with entry to the
whole healthcare system, linking the patient with other services.
Self-efficacy and Confidence
The findings on self-efficacy and confidence are interesting.
Although similar levels of self-efficacy were reported in the 2
arms in the study, improved confidence was found in the
Lai et al
questionnaire measuring satisfaction with care and in the
interviews. The findings suggest that at least the confidence of
some patients might improve under the nurse-led care.
The conflicting results may be associated with cultural
differences arising from Chinese patients" understanding of
self-efficacy and confidence. In the questionnaire on satisfac-
tion with care and in the interviews, the word confidence
was used. Participants understood the word according to its
most common meaning. Their improved confidence may be
a better feeling or an improvement in their psychological
status because of the increased information and support that
they had received from the nurse-led care.50
The concept of self-efficacy first emerged in Western
societies to evaluate the possible ability to perform self-care
strategies. People in Western countries usually acquire self-efficacy
through various methods, such as through self-encouragement
or social support. However, Chinese cancer patients may handle
cancer-related crises in other ways. They may adopt following
the natural course mode of coping, which involves focuses on
coping but adopting a yielding approach.51 Therefore, there is
a possibility that the patients may have felt that the items in
the self-efficacy questionnaire were not perfectly suitable for
their situation because the SUPPH questionnaire was developed
in the West. The interesting findings suggested further avenues
for exploration, which could help researchers to design interven-
tions for self-efficacy and confidence tailored to particular cultures.
Factors Contributing to Nonsignificant Results
Although some benefits were identified from the interviews
and the results on the satisfaction with care, nonsignificant
differences were found in the QOL, self-efficacy, and distress
levels associated with most symptoms. The nonsignificant
results may be due to several factors. The first factor may be
the young ages and good health of the participants, because
nurse-led care programs might be less effective for patients
who are younger and healthier and with newly diagnosed
disease.11 The second factor may be the participants" employ-
ment status and family support. During the treatment, almost
all took time off work, and most were cared for by their family
members. This gave them abundant time to recover from the
chemotherapy. The third factor may be the minor adverse effects
caused by the chemotherapy. The distress levels associated with
most symptoms were at the low level in the study. The findings
were in agreement with another 2 local studies, which found
that the cancer patients" overall distress levels associated with the
symptoms were not severe.52,53
These factors may lead to slight changes in the QOL and
daily living of some patients. Hence, they may not greatly need
the support from the nurses. In the interview, 1 participant
shared the opinion that patients experiencing higher levels of
suffering would be in greater need of the nurse-led care. Meanwhile,
the self-care behaviors of the patients may be weakened because
of their good life arrangements. They may not fully comply with
the nurses" suggestions. Low practice adherence to the interven-
tion was 1 reason for the negative results of intervention studies
aimed at improving the QOL of cancer patients.54 Without
Nurse-Led Care Program in Chemotherapy Day Center
Copyright 2017 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
practice, the self-efficacy may not improve as well because it is
a dynamic factor that increases with successful experiences.55
As a result, the effects of the nurse-led care may be diluted.
Another behavior-related factor may be the reduced nurs-
ing dosage for each problem. As a holistic care model aiming
to address all possible needs of cancer patients, the intervention
nurses tried to resolve all of the problems that were identified in
each intervention session. Accordingly, the dosage for each
symptom or problem may not have been adequate. Compared
with the single-component intervention studies or the studies
for certain symptoms, the nurse-led care may have had less effect
on a single problem. Hence, some outcome measures probably
did not show significant changes under the nurse-led care.
Individualized interventions may lead to challenges in
evaluating self-care behaviors. A difficulty arising from this
issue is how to monitor the self-care behaviors of the patients
in a multicomponent intervention study. The problems expe-
rienced by cancer patients receiving chemotherapy and their
self-care strategies may vary greatly. Changes may also occur as
the course of chemotherapy proceeds. It was difficult to establish
standard criteria to evaluate the patients" self-care behaviors for
multiple problems in the study. Although 1 advantage of the
nurse-led care was that it delivered holistic assessment and
individualized care, it also implied that different patients might
use different strategies to cope with the same problem.
The Reflection of the Theoretical Framework
The study was a preliminary attempt to adopt the Bridges"14
transition theory and Meleis"15 transition theory as a theoretical
framework of an intervention study for cancer patients. Although
many studies were guided by Meleis"15 transition theory to
examine nursing-related phenomena or nursing interventions in
various settings, few studies had adopted the theory to guide an
intervention study for cancer patients receiving adjuvant chemo-
therapy. From the findings of this study, considerations on the
component variables in the theoretical framework were suggested.
In the study, the QOL and self-efficacy were adopted as
the indicators of participants" sense of well-being during the
chemotherapy-related transition, which were similar between
the intervention arm and the control arm. The results indicate
that these 2 variables might not be the most suitable ones to reflect
the outcomes of the chemotherapy-related transition. Many
indicators of the subjective sense of well-being and mastery of new
behaviors have been adopted in previous studies as responsive
indicators of transition, including effective coping, sense of
dignity, effective coping, role satisfaction, growth, empower-
ment, knowledge or cognitive skill, decision making, and so
on.15 Whether these indicators are suitable for cancer patients
receiving chemotherapy needs further exploration in future.
Limitations and Implications
Several limitations should be considered when generalizing the
findings of the study. This study was an open-label and single-
center randomized controlled trial (RCT). Although some
measures were adopted to prevent the impact of incomplete
Cancer NursingTM, Vol. 00, No. 0, 2017 n 13
blinding, the results of the study are not strong enough to
confirm the effectiveness of the nurse-led care program for
cancer patients receiving outpatient-based chemotherapy. Par-
ticipants in the study were breast cancer patients in stages I to III
receiving adjuvant chemotherapy, who were middle-aged
Chinese women from Hong Kong with good prediagnostic
health. This patient population may mean that the generaliz-
ability of this study on nurse-led care is limited with respect to
patients of different social and clinical backgrounds. The
methods to handle the missing data of the symptoms may have
resulted in an underestimation of the SEs or too small P values.
Besides, as the chemotherapy-related symptoms alleviate after
the completion of chemotherapy, the differences between the 2
arms may dissipates over time. Hence, caution should be paid
when interpreting the results of the symptoms where statisti-
cally significant differences were found.
Despite the limitations, the encouraging findings suggest
that the nurse-led care program is worth applying in clinical
settings. In the study hospital, the prechemotherapy nurse
consultation has been integrated in the routine care for all
cancer patients receiving chemotherapy for the first time. The
nurse-led telephone follow-up has been delivered to colorectal
cancer patients undergoing chemotherapy. The nurse-led care
program could be also applied to breast cancer patients in
other chemotherapy day centers in Hong Kong.
This study sheds light on the future directions for research.
For example, more RCTs are needed to judge the effective-
ness of nurse-led care for patients receiving outpatient-based
chemotherapy. The challenges of encouraging self-care
behaviors among patients and monitoring the behavioral
changes in multiple-component intervention studies also need
to be addressed. In addition, the impact of culture on self-
efficacy and confidence is worth exploring to facilitate the
design of interventions tailored to culture.
n Conclusion
To summarize, this study was one of a few RCTs to examine the
effects of a nurse-led care program for breast cancer patients
receiving adjuvant chemotherapy in outpatient settings. The
nurse-led care program could be helpful in managing the distress
levels associated with oral problems, fatigue, peripheral neurop-
athy, and distressful feelings. It may have had slight impact on
QOL, self-efficacy, and confidence of some patients. Psycholog-
ical support and the provision of adequate information are 2
effects of this service model. The satisfaction with care improved
as well. The nurse-led care program is suitable for implementa-
tion among breast cancer patients and can be feasibly applied in
other chemotherapy day centers in Hong Kong.
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