Sufficient the methodology of this study. In this

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 Sufficient sample was
taken to estimate the level of adherence to oral anticancer medications.
Questionnaire was used to assess the adherence. Descriptive cross-sectional
study was carried out as the methodology of this study. In this descriptive
cross-sectional study, data were collected on the whole study population at a
single point in time to examine the relationship between health-related state and
other variables of interest. Participants were selected randomly. Collaborative
relationship was maintained with Apeksha Hospital in the process of gaining
permission from the director, consultant oncologists, and also with the
hospital pharmacy.

3.2 Study setting

Study was carried out at Apeksha hospital Maharagama which
is the main cancer unit in Sri Lanka where majority of cancer patients visit for
their treatments. Selection of participants for this study was easily done
because of the dense population of the hospital. Cancer outpatients visit
clinics regularly in order to get monitored their disease condition by the
consultants. Therefore this study setting was the ideal for the purpose of the

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Sample size and sampling method

Participants were
selected randomly from the patients who visit the clinics over the period of 3
months. Around 40-55 outpatients who are on oral anticancer medications were
visiting to a clinic on one day. Therefore easily 202 patients were selected as
the sample size after exclusion of the defaulters. Patients who visited cancer
clinic during the study period and fulfilled inclusion criteria were selected.
Patients who were within the age range of (10-75) years, who were diagnosed
with cancers and undergoes oral chemotherapy for more than two years and who
were conscious and volunteer to give consent were chosen. They were
cooperatively participated for the study.


There are various
direct and indirect methods are applying to measure the adherence. One of the
direct method of measuring the adherence is blood and urine analysis for drug
concentration. But it’s difficult to carryout in the undergraduate level.
Therefore for this type of study, indirect methods are most suitable. Indirect
methods of measuring the adherence are pill counts, questionnaires,
self-reports. Here for this study questionnaire was used to measure the
adherence. Questionnaire was conducted as an interview-based examination.
Because this method can cooperatively interact with participants to obtain accurate


 3.4 Inclusion criteria


Patients who visited cancer clinic during
the study period and fulfilled inclusion criteria.

Patient’s age is between the ranges of 10-75

Patients who take oral chemotherapy treatment
with the other treatments also.                       (Combined effect)

Patients who are taking oral chemotherapy for at
least for two years.

Cancer out patients.


3.5 Exclusion criteria

patients who are not taking oral chemotherapy.

patients admitted in the wards.

whose age is less than 10 years.

whose age is more than 75 years

3.6 Data collection tool

It’s clear that adherence plays
a key role in the treatment of oral chemotherapy. Therefore there must be a
good way to measure the adherence. Then the level of adherence can be
determined. Necessary steps can be taken to enhance the adherence. There’s no
gold standard for measuring adherence and thus various strategies have been
reported in literature (WHO, 2003). For this study questionnaire was used as
the data collection tool.


Questionnaire was developed
using a Japanese questionnaire used in a survey which was conducted at Japan on
oral anticancer medication adherence by cancer outpatients (Kimura et al,
2014). That is composed of questions related to taking medications. Japanese
questionnaire was modified focusing Sri Lankan context. It is composed of
thirty-two questions including demographic data of the patients (1-7),
medication related factors (8-11), and health care system related factors
(12-15), patient related unintentional factors (16-24), patient related
intentional factors (25-28) and patient’s attitudes (29-32) that effect the
adherence. Questions were categorized according to the above criterions as it
is then easy to evaluate the factors which affect on adherence.


3.7 Data collection

Initially participants were
briefly informed about the study and informed consent was obtained by
distributing information and consent forms among them. Information sheet was
contained information about the way how the study conducted. Consent form was
contained questions to ensure that whether participants have understood the
information provided. Information sheets, consent forms and questionnaires were
distributed among 202 cancer outpatients.

3.8 Ethical clearance.

approval was obtained from the Ethical Review Committee of the Faculty of
medicine, Kotelawala Defence University (Reference no: RP/S/2017/23 on
30/08/2017) (appendix 2).Then approval
was obtained from the Apeksha Hospital Sri Lanka.

The data collection procedure was conducted
for nearly three months. During that period patient’s comfort was ensured. This
study was absolutely free of risks. Therefore no actions were needed to
minimize risks.

Cancer outpatients who were taking oral
anticancer agents are selected for the study under the guidance of
the supervisor. Then the study conducted as an interview based examination. The
process of the study was explained to the participants and their guardians. The
participation was conducted without any compulsion and patients had the right
to avoid participation at any time. Also they were informed that avoiding participation
at any time was not an issue to their current treatments. No procedure was needed
to withdraw the consent. Participation was entirely volunteer.

If there was any problem arised in patients regarding the research they were free to ask that from the
investigators. No procedure was
needed to that. Participants will
be informed about the results of this study by putting an article on their
relevant notice board. After this study if any improvement is needed in
medication adherence, then there will be a proper medical service to guide

Privacy and the confidentiality of the participants was ensured at all
stages of the study. Consent from patients was obtained in both written form
and verbally. Confidentiality of all records was guaranteed and no information
by which they could be identified was released or published. Data that was
collected by patients was kept protected and full confidence was granted. All data
was protected by password system and had access only to investigators and
supervisors. The data had never been used in such a way that they could be
identified in any public presentation or publication without their express
permission. After two years following the study period all the data will be
permanently deleted from the authorized computers and questionnaire forms will
be destroyed.

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