Study setting and population
This cross-sectional study was carried out among two groups of women interested in participating at a peripheral women clinic at Piliyandala Medical officer of Health (MOH) area and women who were diagnosed with breast cancer, who attended breast cancer clinics which were conducted at the National Cancer Hospital (NCH) in each group from January to June, 2018. Peripheral women clinics invite people to participate in a planned comprehensive cancer control program. National Cancer Hospital is the Sri Lankan main oncological institution where almost all the patients who have diagnosed with breast cancer receive treatments. For the second sample the investigators recruited patients who have already diagnosed with breast cancer with in the age range of 30—65 years.
The Well Women clinics (WWC) are the clinics that targets on preventive healthcare of the Sri Lankan society. These clinics were conducted under the supervision of the Ministry of Health. Piliyandala MOH division was selected since, the estimated population in Piliyandala MOH area is 192,390 and the women who are eligible to participate for the WWCs are 1% of the above population. The area span is about 42 square kilometers. Piliyandala MOH area consists of 14 clinic centers. The study outcome is relatively can be generalized to the area since almost all 14 WWC cover up in the study.
As a part of this population based program, the women’s awareness levels about different aspects of breast cancer, including risk factors, early warning signs, and therapeutic and screening approaches were evaluated. During the study period, a self-administered questionnaire was distributed among women attended to those institutions before contributing at screening and educational programs. The participants were informed about the increased incidence rate of breast cancer, particularly among the young Sri Lankan female population.
Sampling method
Five clinic areas and twenty five WWCs were randomly selected from the MOH area, Piliyandala. Four clinics, five wards and the chemotherapy unit were selected to collect data from the National Cancer Hospital, Sri Lanka. The whole population had fulfilled the inclusion criteria were recruited until the sample size is achieved.
Sample size was calculated using the equation of n = z2 p (1-p) / d2 where n = sample size, z = 1.96; critical value of specified confidence at 95% confidence interval, p = probable estimate of proportion of the prevalence for awareness about risk factors for breast cancers among females in Sri Lanka (78%) [6]. Minimal sample size was calculated as 265. In addition, 20% sampling error was added to minimize irresponsible and recording errors and the final sample size was 317. In order to compare the awareness of breast cancer risk factors of women who already have breast cancers and who are apparently healthy; 317 women were selected from each group.
Women aged between 30 to 65 years attended to the breast cancer clinics in national hospital and the peripheral clinic were included for this study. Women, who are less than 30 and more than 65 years, were already diagnosed with a breast cancer and physically and mentally disabled women were excluded from the study.
Study Instrument and Variables Assessment
A self-administered questionnaire was used for data collection. The questionnaire consisted of 34 questions to assess the knowledge, attitude and the practice about breast cancer risk factors and early detection techniques. The questionnaire was organized in to five sections such as socio-demographic variables, that section includes questions such as well-established risk factors, early warning signs, questions regarding early detection techniques and questions regarding the awareness and attitudes screening methods and negligence on population practices. Descriptively the socio-demographic questions age, education status (no formal education, less educated and university graduation/diploma), no of children, breast fed or not, family history of breast cancer were asked. Secondly well established risk factors that influence for the breast cancers were evaluated such as infertility, early age at menarche, age of menopause, breastfeeding, family history of breast cancer, being obese, smoking and alcohol consumption diet, Stress and Depression and finally consumption of Hormone Replacement of Therapy (HRT) were assessed from the sample. Thirdly the researchers included questions regarding nine established warning signs, lump in breast, redness of the breast, breast or armpit pain, discharges other than breast milk in nipple, rash on the nipple, changing the shape and the size of the breast, changing the position of nipple, and finally pulling in of the nipple. Fourthly questions were raised regarding the early detection techniques, specifically about the screening method and the practices and knowledge regarding them. This included Fine Needle Aspiration biopsy for Cytology (FNAC), CT scan, mammography, monthly breast self-examination (BSE), and biannual breast examination by a physician also known as the Clinical Breast Examination. Final section included the questions regarding the awareness and attitudes on screening methods and negligence exists among the population. There patients direct attitudes regarding the early detection techniques were assessed while linking them with the courses for negligence.
A self-administered questionnaire was formulated in Sinhala and translated into English and Tamil. All the information regarding privacy and confidentiality of the participants was provided in the information sheet. Privacy and confidentiality was ensured at all stages of the study. Participants of the MOH clinics were addressed after the health education session by the MOH. Participants of National Cancer hospital were contacted at the wards, clinics and the chemotherapy unit of the Hospital. They were addressed individually whenever they were free while the ongoing treatments were providing. Once the participants were determined to be eligible to participate in the study, they were approached by the investigators to explain the process of the study.
They were explained that their participation is entirely voluntary and without any compensation. Further, the information sheet and the consent form were distributed among eligible participants and written informed consent was taken. The information sheet was kept with the participant to contact the investigators in any time if they need any clarification or any complaints regarding the study. Only the consent forms, which ensure that participants have understood the information, was collected back. Participants were informed that their absence of participation will not be affected during their treatment or any other care in the future. They were informed that they can withdraw from the study at any time, before or during the data collection process. The name of the participant was not recorded on questionnaires. The access to the collected data was only for the investigators, the co-supervisor and the supervisor of this study. The investigators will protect the confidentiality and the privacy of the participants in all the stages of the study. The questionnaire was pre-tested before using in the study at a well women clinic at the Piliyandala MOH area and at the National Cancer Hospital, Sri Lanka to assess the feasibility of the study and drawbacks of the questionnaire. Pre-test was done among women who fulfilled the inclusion criteria.
The informed written consent was taken from all the participants of the study. The anonymity and confidentiality of data and privacy of the participants were properly maintained by using a serial number. Participants were fully informed regarding the participation of the study is on voluntary basis and they can leave the study on their preferences moreover participants were convinced that there will be no any negative consequences occur due to the refusal in terms of accessing their health care services. Participants’ privacy and confidentiality were maintained by the researchers by adhering to a serial number system instead of using their names. The data collection process was conducted by maintaining the privacy of the participant.