Evidence-Based Care: Nurse-Led Care for Breast Cancer Patients

This report presents a critical appraisal of a randomized controlled trial investigating the effectiveness of a nurse-led care program for breast cancer patients receiving outpatient chemotherapy in Hong Kong. The study, a single-center, open-label, two-arm parallel trial, compared routine hospital care with nurse-led care plus routine care. The research evaluated the quality of life, self-efficacy, symptom distress, and satisfaction with care using questionnaires administered before, during, and after chemotherapy. The intervention arm showed significant improvements in oral problems, fatigue, peripheral neuropathy, and overall satisfaction. The report details the study design, eligibility criteria, interventions, outcome measures, and statistical analyses. The findings highlight the potential benefits of nurse-led care in providing comprehensive support and improving outcomes for breast cancer patients undergoing chemotherapy, emphasizing the importance of personalized and patient-centered care within an oncology setting. The report also includes the study's limitations, and its implications for clinical practice and future research.

Running head: Evidence Based Care For Breast Cancer Patients
Evidence Based Care for Breast Cancer Patients
Name of the Student
Name of the University
Author Note

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Nowadays, cancer is one of the serious as well as significant health issues in Hong Kong.
Outpatient-based chemotherapy among cancer patients in Hong Kong are facing gradually
increasing demand for chemotherapy services. However, the opposing effects associated with
chemotherapy can impose great hardship on breast cancer patients of Hong Kong. This, in
turn, also gives rise to series of negative outcomes. Considering the effectiveness, safety,
high patient satisfaction Nurse-led care has been highly recommended. It is noteworthy to
state that this randomised clinical trial study depicts the effectives of nurse-led care for breast
cancer patients receiving outpatient chemotherapy from a few aspects, including clinical
information and psychological support, dealing adverse with effects, and improving
satisfaction with care. The following are the critical appraise for this randomised controlled
trial.
1aIn the study conducted on breast cancer patients the control groups and the experimental
groups were equally randomised (1:1). This, in turn, assures that there is equal participation
from all the participants. The study conducted in the participants were evaluated both before
and after randomization of trials. The control groups in such experiment minimises the effect
of variables (Warrington, Absolom&Velikova, 2015). The experimental group does not have
any test variable and are generally used to find answers in an experiment while control
groups do not receive any experimental treatment. There were two groups for this study: one
got routine hospital care and the other received nurse led interventions.
1bConsidering the fact that the study was an open-label, equally randomized trial which
means that no information was withheld from trial patients. Both the patients both control and
experimental group was made to know about all concerned information (Becker et al, 2017).
This study was a single-center, two arm parallel trial. The controlled arm (breast cancer
patients) received normal routine hospital care whereas the intervention group received the
nurse-led care along with routine hospital care. This study evaluated the quality of life,

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symptoms associated with distress levels (after chemotherapy), self-efficacy as well as high
satisfaction level associated with proper nursing care. In order to evaluate these outcomes,
questionnaires were given to the breast cancer patients before randomization (T0), in the
middle of chemotherapy (T1), and after one month of chemotherapy (T2). Additionally, same
participants were interviewed in the intervention arm at T2.The intervention arm participants
expressed that they had significantly lower oral problems, fatigue,peripheral neuropathy, and
increased satisfaction with care in comparison to the control arm participants. They also
expressed the fact that the nursing led care was significantly useful in order to provide the
proper information and communication opportunities. It can be concluded from this paper
that the breast cancer patients received significant personalised and comprehensive care.
2a Cancer is one of the serious as well as significant health issues in Hong Kong. Outpatient-
based chemotherapy among cancer patients in Hong Kong are facing gradually increasing
demand for chemotherapy services for more than 10 tears. However, the opposing effects
associated with chemotherapy can impose great hardship on breast cancer patients of Hong
Kong. This, in turn, also gives rise to series of negative outcomes.Considering the
effectiveness, safety, high patient satisfaction Nurse-led care has been highly recommended.
Some significant reports on nurse-led breast cancer care exist. However, insufficient and
improper evidence associated with nurse-led breast cancer care patients during outpatient
based chemotherapy has to be avoided. Thus, the nurse-led care programme was developed
for the breast cancer patients in a Chemotherapy Day Centre (Haviland et al., 2013).
2bThe specific objective of this clinical study was to evaluate the significance of the effects
of a nurse-led care programme on improving the quality of life of the breast cancer patients.
This study hypothesized that no significance difference exists between the participant and
control arm in QOL during chemotherapy. The secondary hypothesis was to compare the two

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arms for self-efficacy and understand the significance of nurse-led care programme on breast
cancer patients (Kleinpell, 2017).
3aThe trial design of this study included a single-centre, open-label, 2-arm parallel trial with
equal randomization (1:1). This study was also conducted in the chemotherapyday centr of an
acute care hospital in Hong Kong.
3b No significant changes were made after trial commencement.
4a In this study, the eligibility criteria for the participants included at least 18 years of age,
diagnosed with primary breast cancer, getting treatment with adjuvant chemotherapy, 60
score on Karnofsky Performance Scale, able to speak Cantonese and write Chinese, available
to be communicated through telephone.
4bThe nurse-led care program can significantly be applied to breast cancer patients in several
hospitals of Hong Kong.
5 In this study two types of intervention were conducted where participants are subjected to
both nurses led care and hospital care. The hospital led care was normal and put more
emphasis on chemotherapy while nursing intervention had tools of intervention which were
lengthy and more procedures. NNT refers to the therapeutic interventions while NNH was the
risk factor associated with a clinical trial. In this study the risk factor was small while NNT
was low which emphasis that the treatment or the interventions was high (Kotronoulas et al,
2017). The interventions by the nurses were quite significant in the clinical trials. The
intervention effect was quite significant in the clinical trial. The effect size between the two
group is significant in understanding the difference and the advantages over the use of tests.
The effect size in this clinical study is dimensionless which states the outcome of the two
study. Reporting the effect size is significant to interpret the significance of the clinical trials.
It is often referred as treatment effect, which also calculates the result of the treatment.

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6a Both the primary and secondary clinically significant outcomes were measured. The trial
addressed a clear topic of nurse led intervention care for cancer patients. The clinical study
was done between two groups and randomized to make sure that the study holds clinical
significance.The care provided by the nurses were evaluated by asking questions to the
patients. The distress level of associated symptoms gave vital information on the efficacy of
the clinical study that is change in menopause and sexual relationship. The most common
symptom came out to be hair loss (91.7% to 98.3%). The demographic and clinical data was
also considered for the clinically significant outcomes. Results on self-efficacy and quality of
life was properly given by use of data and dimensions. The outcome of satisfaction from care
was carefully pointed out between the two groups. The intervention arm showed higher rate
that the control arm. The qualitative results carried on ten participants where four themes
were decided for the interview data and later evaluated. The study was confined to personal
wellbeing; therefore, family relationship was not given much importance.
6b No significant changes were observed in trial outcomes after the commencement of trial.
7a The sample size was calculated by using Functional Assessment of Cancer Therapy Y
General (FACTG). Sample size was about 126 patients. Patients were divided into the 2 arms
(63 patients per arm).
7b No interim analyses as well as stopping guidelines were used in this clinical study.
8a Participants who received a four-cycle therapy was divided into group A. The patients
who received six cycle chemotherapy was denoted to group B. the sequences were then
randomly sequenced and then generated with 1:1 allocation. The allocation sequence was
then sequentially numbered. The nurses who carried out the care plan were concealed about
the fact of the subjects in the clinical trial. This ensured that the care provided by nurses to
subjects are not different for the groups.

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8b Using a block size of 4, the random allocation sequences for two different groups were
generated. An online randomization generator generates random allocation sequences.
9 At first the allocation sequences were properly packaged in serially numbered, sealed
envelopes. A third party conducted both the generation of allocation sequences as well as
packaging of the allocation sequences before the commencement of the study. After joining,
the researchers opened the envelopes and it was randomly assigned to both the control group
and participant group (Eldridge et al., 2018).
10 The assessment conducted were required over a long time that is around more than one
year. The long period is ideal for carrying out a clinical trial and is beneficial in accessing the
results. Participants were selected from June 2012 to September 2013. Long period is desired
in clinical trials because the scope of errors is minimised (Frieden, 2017). In case of drug
trials long interval is discouraged as it can hamper the study period but in case of nursing
intervention long period is desired. There can be difference in care provided by the nurses,
therefore for uniformity in the practise long interval is desired in this clinical trial. The effects
of the intervention are then accurate due to its long interval (Deaton & Cartwright, 2018).
11a The subjects were blind to the study group and the nurses were aware of the clinical trial
but the participants were concealed. The participants were subjected to nursing care and its
intervention for the study. The study comprised of participants from the hospitals and were
specially recruited by one of the researchers who screened the medical records of these
patients. Participants were divided based on treatment that they were receiving (Deaton &
Cartwright, 2018). The allocation was randomly sequenced and was conducted after the start
of the study by the third party.
11b Not relevant.
12a To analyze the quantitative data of this clinical study the IBM SPSS was used. The
principle named intention-to-treat was carried out for this study.

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12b ANOVA and the independent-sample t test both were used as a statistical method to
compare between the intervention participant group and the control group with reference to
QOL (quality of life).
13a After conducting in depth assessment, total, 120 eligible patients (31.1%) took part in the
study. However, in the data analysis, only 58 participants were included analysis of the
primary outcome of the intervention and 62 patients were involved for routine care.
13.b) while One hundred twenty-four eligible patients (31.1%) took part in the study where
60 will receive intervention and 64 will be in the control arm, four participants were
excluded from the study. from both groups, two participants were excluded who failed to
meet the inclusion criteria and demographic data such as a history of psychiatric, previously
received chemotherapy.
14a) The dates defining the period of recruitment and follow up is from June 2012 to
September 2013.
14b) The reason behind ending the study is that the study participants failed to exhibit any
significant result in relation to the study. The result of the study was not strong enough to
confirm the effectiveness of the nursing led care program. Hence, the researchers failed to
continue the study.
15.The baseline characteristics such as demographic and clinical characteristics include
Education background, Marital status, Religion,Living arrangement,Prediagnosis
employment, Employment during treatment, Payment of drug expenses,Difficulty in making
payment, Disease stage and health history.
16.Total 271 intervention sessions was design for the study. For each group, 62
participants were involved in each analysis and the original assigned group was for 64
participants.

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17a) Intervention arm reported with median 9 was significantly higher than that reported by
control participants. The mention was secondary outcome of the study was observed.
Considering the effect size (f) with a 5-point difference (95% confidence interval) for the
study was 0.29 (5/17).
b) For binary outcome, no presentation of both absolute and relative effect sizes is
recommended in the study. However, approximate effect size 1.5.
18. The quality of life, self-efficacy, symptom distress levels, and satisfaction with care
were evaluated with questionnaires before randomization in order to gather the idea of the
research.
19. The unintended harm in this case for the interventional group include not respecting
the dignity of the participants, confidentiality of the patients. The other impact may be
overdose of the intervention or any kind of hazard. However, no such harm can be observed
for the control.
20. The limitation of the study include open-label and singlecenter randomized controlled
trial (RCT), the results of the study are not strong enough to confirm the effectiveness of the
intervention and the generalizability is the limited. The potential bias of the study include
the study was not completely blinded which may lead to information bias.
21. Considering the generalisability of the study, the study intervention such as nursing led
program is not effective.
22 Not applicable.
23Registration number and name of trial registry were not mentioned properly.
24Full trial protocol can notbe accessed.
25This study was funded by Central Research Grant from the Hong Kong Polytechnic
University (grant RU0Q).

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