Sufficient the period of 3 months. Around 40-55 outpatients

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

3.2 Study settingStudy was carried out at Apeksha hospital Maharagama whichis the main cancer unit in Sri Lanka where majority of cancer patients visit fortheir treatments. Selection of participants for this study was easily donebecause of the dense population of the hospital. Cancer outpatients visitclinics regularly in order to get monitored their disease condition by theconsultants.

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Therefore this study setting was the ideal for the purpose of thestudy.3.3Sample size and sampling methodParticipants wereselected randomly from the patients who visit the clinics over the period of 3months. Around 40-55 outpatients who are on oral anticancer medications werevisiting to a clinic on one day. Therefore easily 202 patients were selected asthe sample size after exclusion of the defaulters.

Patients who visited cancerclinic during the study period and fulfilled inclusion criteria were selected.Patients who were within the age range of (10-75) years, who were diagnosedwith cancers and undergoes oral chemotherapy for more than two years and whowere conscious and volunteer to give consent were chosen. They werecooperatively participated for the study. There are variousdirect and indirect methods are applying to measure the adherence. One of thedirect method of measuring the adherence is blood and urine analysis for drugconcentration. But it’s difficult to carryout in the undergraduate level.Therefore for this type of study, indirect methods are most suitable. Indirectmethods of measuring the adherence are pill counts, questionnaires,self-reports.

Here for this study questionnaire was used to measure theadherence. Questionnaire was conducted as an interview-based examination.Because this method can cooperatively interact with participants to obtain accurateanswers.  3.4 Inclusion criteria ·        Patients who visited cancer clinic duringthe study period and fulfilled inclusion criteria.

·        Patient’s age is between the ranges of 10-75years.·        Patients who take oral chemotherapy treatmentwith the other treatments also.                       (Combined effect)·        Patients who are taking oral chemotherapy for atleast for two years.·        Cancer out patients. 3.5 Exclusion criteria·        Cancerpatients who are not taking oral chemotherapy.·        Cancerpatients admitted in the wards.·        Patientswhose age is less than 10 years.

·        Patientswhose age is more than 75 years3.6 Data collection toolIt’s clear that adherence playsa key role in the treatment of oral chemotherapy. Therefore there must be agood way to measure the adherence. Then the level of adherence can bedetermined. Necessary steps can be taken to enhance the adherence.

There’s nogold standard for measuring adherence and thus various strategies have beenreported in literature (WHO, 2003). For this study questionnaire was used asthe data collection tool.  Questionnaire was developedusing a Japanese questionnaire used in a survey which was conducted at Japan onoral anticancer medication adherence by cancer outpatients (Kimura et al,2014). That is composed of questions related to taking medications. Japanesequestionnaire was modified focusing Sri Lankan context. It is composed ofthirty-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 relatedintentional factors (25-28) and patient’s attitudes (29-32) that effect theadherence. Questions were categorized according to the above criterions as itis then easy to evaluate the factors which affect on adherence.

 3.7 Data collectionmethodInitially participants werebriefly informed about the study and informed consent was obtained bydistributing information and consent forms among them. Information sheet wascontained information about the way how the study conducted. Consent form wascontained questions to ensure that whether participants have understood theinformation provided.

Information sheets, consent forms and questionnaires weredistributed among 202 cancer outpatients. 3.8 Ethical clearance.Ethicalapproval was obtained from the Ethical Review Committee of the Faculty ofmedicine, Kotelawala Defence University (Reference no: RP/S/2017/23 on30/08/2017) (appendix 2).Then approvalwas obtained from the Apeksha Hospital Sri Lanka. The data collection procedure was conductedfor nearly three months. During that period patient’s comfort was ensured.

Thisstudy was absolutely free of risks. Therefore no actions were needed tominimize risks. Cancer outpatients who were taking oralanticancer agents are selected for the study under the guidance ofthe supervisor. Then the study conducted as an interview based examination. Theprocess of the study was explained to the participants and their guardians. Theparticipation was conducted without any compulsion and patients had the rightto avoid participation at any time. Also they were informed that avoiding participationat any time was not an issue to their current treatments.

No procedure was neededto 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 theinvestigators. No procedure wasneeded to that. Participants willbe informed about the results of this study by putting an article on theirrelevant notice board.

After this study if any improvement is needed inmedication adherence, then there will be a proper medical service to guidethem.Privacy and theconfidentiality 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 theycould be identified was released or published. Data that was collected bypatients was kept protected and full confidence was granted.

All data wasprotected by password system and had access only to investigators andsupervisors. The data had never been used in such a way that they could beidentified in any public presentation or publication without their expresspermission. After two years following the study period all the data will bepermanently deleted from the authorized computers and questionnaire forms willbe destroyed