This section presents the methods and materials used in conducting this
study.
Study
design
Kothari (2004) defines the research design as the arrangement of
conditions for collection and analysis of data in a manner that aims to combine
relevance to the research purpose with economy in procedure. This study adopted
a descriptive cross-sectional study design focusing on the patients with breast
cancer at MTRH. All patients with a confirmed diagnosis of breast cancer and
who met the inclusion criteria were recruited for the study.
Overview
of study area
Recruitment of the study subjects was carried out at the breast cancer
out-patient clinic at Chandaria cancer and chronic disease management center
and in-patient’s unit (surgical, medical wards) at MTRH in Eldoret, Uasin Gishu
County, Kenya. MTRH is the second largest national referral hospital and covers
the western Kenya region with a population of about 16 million. It is a
teaching and referral hospital used by Moi University. The hospital serves
patients from western Kenya, north rift, and south rift regions, Eastern Uganda
and Southern Sudan. MTRH was chosen for the study because it is a national
teaching and referral hospital that has an oncology clinic that covers the
western Kenya region and therefore serves a significant size of the population
in cancer diagnosis and treatment. In addition, MTRH is a busy referral center
and likely to have sufficient patient numbers for the study.
Cancer
treatment at MTRH
All types of cancer patients both pediatrics and adult (gynecological,
surgical, and medical) patients are attended to at the center. The oncology
clinic is run on Mondays and Wednesdays between 8.00 am to 2.00 pm, but remains
open for patients who come on any other day of the week.
Census
sampling
Census sampling is defined as a statistical method of research where all
members of the population are studied [8]. A
census is an attempt to list all elements of in a group and to measure one or
more elements in that group. Some of the benefits that necessitate a use of
this type of sampling technique is the need for enough number of participants
in order to have a high degree of confidence in the survey results. The study
populations were breast cancer patients above 18 years seen at the out-patient
clinic at MTRH, those admitted to the medical ward with confirmed cancer of the
breast and the patients in the surgical ward admitted for surgical procedures. The
number of patients with a histological diagnosis of breast cancer was 102 from
January2016-December 2016. This study therefore sought to all co-opt all 106
breast cancer patients but ended up using 79 patients for the study.
Inclusion
criteria
·
Adults (aged 18 or older) who have been confirmed to
have breast cancer;
·
Patients in the medical/surgical wards who have been
confirmed to have breast cancer;
·
Patients at Chandaria cancer and chronic disease
management center outpatient clinic who have been confirmed to have breast
cancer.
Exclusion
criteria
·
Patients in a coma;
·
Patients with emotional instability.
Data
collection
The following section identifies the tools used in collecting data and
the procedures adhered to in dealing with patients during data collection. This
study utilized the HAM-D scale and questionnaire to collect data.
HAM-D
scale
A 17-item Hamilton Depression Rating Scale (HAM-D) was used to assess
depression severity among patients. The total score is obtained by summing the
score of each item, 0–4 (symptom is absent, mild, moderate, or severe) or 0–2
(absent, slight or trivial, clearly present). For the 17-item version, scores
can range from 0 to 54. Since its development in 1960 by Dr. Max Hamilton of
the University of Leeds, England, the scale has been widely used in clinical
practice and became a standard in research trials. The Hamilton Depression
Rating Scale has proven useful for determining the level of depression before,
during, and after treatment [9]. The Ham-D scale
has demonstrated reliability, validity, and efficiency in adults [10].
The scale has been translated into several languages including French,
German, Italian, Thai, and Turkish. In comparison to the Beck Depression
Inventory, a meta-analysis suggested that after treatments, the HAM-D was more
'sensitive to change' on retesting, and this is probably why it has been so
widely used in clinical trials.
Questionnaire
A questionnaire containing the patients’ unique number of
identifications was also used. The questionnaire was designed for adults and
used to rate the severity of their depression by probing: mood, feelings of
guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight
loss, and somatic symptoms. The study also followed a number of clinical
procedures when collecting data from the patients which are highlighted below.
Clinical
procedures
Patients admitted were recruited for the study within 72 hours. In
addition, the principal investigator recruited 2 research assistants who were
trained by the researcher on how to carry out the study. Their main
responsibility was to assist with the identification of the new patients,
retrieving their files, and getting all the required information from the
participants.
Data
processing and analysis
Data processing is defined as the steps involving in editing, coding,
classification and tabulation of collected data [11].
The sole purpose of processing is to prepare the data for analysis. The study
data collection forms were checked at the end of each day for completeness and
appropriate filling and then the data was coded before it was entered into
SPSS. In order to ensure data safety and protection, a personal computer was
used during the study to store the collected data. The personal computer was
password protected. During analysis, descriptive statistics was used especially
for continuous data. Means, median and mode was also used for categorical data
which was displayed as frequencies and percentages. Data was analyzed using
STATA version 14. Furthermore, inferential statistics such as Chi-square and
Fisher’s exact tests were used to measure associations of categorical
variables.
Ethical
consideration
The study adhered to the Nuremburg code of research ethics which governs
how research participants are co-opted in a study by seeking informed consent
from the participants. In addition, the appropriate research standards
including proper citations to avoid plagiarism was strictly adhered to.
Patients were informed on all the procedures of the study and informed consent
was sought from the 79 respondents before enrolment. Confidentiality of the
patient’s mental status with regard to depression was kept. Additionally, the
patients who were found to have depression were sent for review by a
psychiatrist and further follow up only after their consent was sought.
Approval to carry out the study in MTRH was sought from:
·
The institutional research and ethics committee to
carry out the study;
·
The chief executive officer MTRH.
Conceptual
framework
This study was guided by the conceptual
framework illustrated in figure 1 that shows that variables associated with
breast cancer patients i.e., age, sex, marital status, education levels,
employment status and chemotherapy were found to have an impact on the onset of
symptoms that are associated with depression (Figure 1).

Figure 1:
Conceptual Framework.