The Effect of Decision-aid Based Counseling on Cervical Cancer Screening Behavior Among Women: a Quasi-experimental Study

Background: The present study was designed to determine the effect of decision-aid-based counseling on changing cervical cancer screening behavior among women. Methods: This quasi-experimental study was conducted on 154 women aged 21-59 with no pap smear history during the past three years. The participants were assigned to the intervention and control groups through randomized block design with block sizes of 4 and 6 and a 1:1 allocation ratio. The data were collected using the socio-demographic and midwifery questionnaire, stages of change checklist, and shared decision making (SDM) and DC questionnaire before and six months after the intervention by interview and then analyzed by SPSS24 software. The chi-square, independent t-test, ANCOVA tests were used. Results: A signicant difference was observed between the two groups in terms of changing the stages of cervical cancer screening behavior six months after the intervention. After the intervention, the frequency of individuals entered the preparation or action stage was more than the control group (P<0.001). The mean score of SDM in the intervention group was signicantly higher than the control group [35.48 (1.18) vs. 27.56 (1.18) (Adjusted mean difference: 7.92; 95% CI: 5.59 to 10.25; P<0.001)]. The mean score of total DC in the intervention group was signicantly lower than the control group [29.16 (1.09) vs. 34.14 (1.09) (Adjusted mean difference: -4.97; 95% CI: 1.09 to 8.04; P<0.001)]. Conclusions: It is suggested to apply decision-aid based counseling along with rutin trainins for promotimg the stages of cervical cancer screening behavior, increasing the , and reducing the DC regarding performing screening.


Background
Cervical cancer is the fourth most common cancer among women globally, especially in developing countries [1,2]. More than 80% of deaths due to cervical cancer occur in the low-and middle-income countries [3], which made the World Health Organization (WHO) call for the global control of cervical cancer in May 2018 to eradicate the disease [4] since this cancer is potentially one of the most preventable cancers [5].
The standard approaches for early detection of cervical cancer are screening women through cytology (Pap smear) and performing an HPV(Human Papilloma Virus) test (co-test). If the cytology is positive, the diagnosis of CIN (Cervix Insito Neoplasia) stages is con rmed based on the colposcopy and lesion sampling [6]. Early detection of cervical cancer through Pap smear is very important in reducing its complications and mortality [7]. However, the available evidence indicates the low level of women's knowledge about screening and early detection methods and their bene ts for cervical cancer, which increases the need to design programs based on the education and promotion of women's knowledge in this eld [8,9].
On the other hand, performing screening for cervical cancer is a decision that people make after receiving su cient information about the method of testing and performing screening and its advantages and disadvantages. It is worth noting that choosing the best option is di cult for patients in many healthrelated decisions. The intervention programs to encourage women to perform screening in uence the women's willingness to decide and subsequently change their behavior to participate in screening programs [10]. As stages of the change model address how informed decisions have been made, and the speci ed stages toward making a behavior change include pre-contemplation stage: I do not intend to do in the next six months (score 1), contemplation stage: I intend to do in the next six months (score 2), preparation stage: I intend to do in the next 30 days (score 3), action stage: I have done recently (score 4), and maintenance stage.
Selecting the best option in many health-related decisions is di cult for patients. This type of decision is regarded as "sensitive preferences," requiring considering the advantages and disadvantages of the options ahead [11]. Decision-aid helps individuals make informed decisions and perform or not perform behavior by providing evidence-based information and expressing the bene ts and harms of health care and consequently, in uences the DC (DC) or the satisfaction with the decision. It is worth noting that decision aid is designed as a tool to support and complement counseling, and it is not considered as a substitute for counseling [12]. Shared Decision Making (SDM) could facilitate the behavior. SDM is de ned as a process in which health options are selected by the patient and healthcare provider [13]. Further, SDM is considered the most important part of patient-centered care [14]. Obviously, as the consumers of health services, patients have rights such as individual care, respecting their beliefs and values, and knowing and participating in care decisions. In the same vein, the rst condition for participating in decision-making is to have su cient information about medical methods and procedures [15].
The results of a study that examined the use of SDM in Iran indicated that despite the legislation of the Ministry of Health regarding patient's informed consent, SDM is still rarely used in the health care delivery system. Further, it is suggested that further studies investigate the impact of SDM in Iran due to the lack of research in this eld [16].
Given the low frequency of cervical cancer screening behavior, the interventions should be performed, and the effect of the interventions on changing women's screening behavior should be investigated based on the theory of behavior change, indicating a person's behavior change in stages. Therefore, considering the importance of cervical cancer screening in reducing mortality and in order to identify the appropriate intervention method to increase women's participation in the cervical cancer screening programs, the present study aimed to determine the effect of decision-aid-based counseling on changing women's screening behavior.

Study design and participants
This quasi-experimental study was conducted from July 2019 to December 2019. The study population were married women aged 21-59 who were referred to health centers in Tabriz, Iran. The inclusion criteria consisted of: married women aged 21-59 with no history of doing Pap smear in the past three years and no intention to do it in the next six months, no history of cervical cancer or a history of cervical cancer among rst degree relatives, literacy, and having a telephone number for follow-up. The exclusion criteria included: pregnant women, history of participating in training and interventions programs related to cervical cancer screening, a history of spotting or bleeding after intercourse, or irregular uterine bleeding.
the change of stages of behavior six months after the intervention in the decision-aid and control groups as a primary outcome and the change of SDM and DC six months after the intervention in the decisionaid and control groups, as the secondary outcomes were considered.

Sample Size
Based on the study of Ezzati et al. [17] and the variable of cervical cancer screening behavior and considering (P1 = 0.55) with a 35% increase in the frequency caused by intervention (P2 = 0.75) and with respect to the power = 80 %, one-sided α = 0.05 in G Power software, the sample size was calculated 70 subjects for each group, which increased to 77, due to a 10% probability of sample loss.

Sampling
The sampling process was started after obtaining the permission of the Ethics Committee of Tabriz Participants were selected from the most crowded healthcare centers in various areas with different socio-economic classes. The author visited the 15 selected centers and obtained data on married women aged 21-59 using the integrated health system (IHS), known as "SIB System". Then, she called eligible women, provided them with a brief description of the research objective and method, and obtained written informed consent from them to participate in the study.

Randomization
The participants were assigned to the intervention (decision-aid based counseling) and control groups using a randomized block design with block sizes of 4 and 6 and a 1:1 allocation ratio. A co-researcher, non-involved in the intervention and data analysis, generated the random allocation sequence by using Random Allocation software (RAS). The intervention type was written on a piece of paper and placed in opaque envelopes, numbered consecutively to conceal the allocation sequence. Envelopes from 1 to 154 were given to the study participants based on the entry order.

Data collection tools
Data collection tools included the socio-demographic and obstetric questionnaire, checklist of change stages, SDM, and DC questionnaire, which were completed through an interview by the rst author. The socio-demographic questionnaire included items such as age, number of children, level of education, occupation, adequacy of household income, and midwifery history, including the number of pregnancies, age of rst menstruation, age of menopause, age of rst pregnancy, etc.
The checklist of change stages is designed based on the transtheoretical model (TTM) of behavior change [18]. The responses were scored based on a 5-point Likert scale as follows: pre-contemplation stage: I do not intend to do in the next six months (score 1), contemplation stage: I intend to do in the next six months (score 2), preparation stage: I intend to do in the next 30 days (score 3), action stage: I have done recently (score 4), and maintenance stage. The maintenance stage was not measured in the present study due to the time limit of the researcher. The tool's reliability was 0.71 using the Kappa index by measuring twice with an interval of two weeks [19].

SDM
The SDM scale was used to assess SDM among participants. A group of German researchers developed the original SDM questionnaire with 15 items in 2001, which was reduced to 11 items in the initial validity conducted in 2006 [20]. The nal version included nine items, and the English version was used for validation in Iran. Participants answer each item using a 6-point Likert scale ranging from 0 (strongly disagree) to 5 (strongly agree). Finally, the total scores were calculated for each questionnaire, and the total scores (minimum 0 to maximum 45) of the questionnaire were determined to specify the perceived level of SDM. about personal values, and lack of support in decision making) and perceived impact of decision making (e.g., the sense of informed choice based on the value and the possibility of the implementation and expression of the satisfaction with choice) [13]. The questions are answered using a 5-point Likert scale ranging from 0 (completely agree) to 4 (completely disagree). All items' scores are summed, divided by 16, and multiplied by 25 to calculate the total score between 0-100. The scores below 25 are associated with decision making, while the scores above 37.5 are related to delayed decision making or uncertainty about decision making. In addition, this scale contains ve subscales, including Informed, value clarity, support, uncertainty, and effective decision. Higher scores on the scale or subscales indicate higher DC and less uncertainty, and less satisfaction with the choice [22]. In a study in Iran, Ghiasvandian et al.
(2013) con rmed the questionnaire's psychometric properties. The tool was provided to ten patients with breast cancer, and the necessary changes were made for face validity. The Cronbach's alpha coe cient was reported 0.94 for the DC questionnaire [23].

Intervention description
The pre-test questionnaires, including socio-demographic and midwifery questionnaire, checklist of the stage of behavior change, and SDM questionnaire, and DC questionnaire, were completed through an interview by control and intervention groups (154 women). In the intervention group (77 people), a 60-90 minutes counseling session based on decision-aid content and routine training was held in the training room of the relevant health center by the Co-author author.
In the session, the author sought to establish good relationships with participants and gave them a feeling of assurance. The information on the prevalence of the disease and the risks of infection, the introduction of cervical cancer screening methods, and the advantages and disadvantages of performing and avoiding screening was provided during the in-person session. The possible advantages and disadvantages of cervix cancer screening methods (Inc. cervix cytology, HPV test, colposcopy) were presented, participants' questions were answered, and a decision-aid book was provided for reading at the end of the session. The content of the decision-aid booklet was prepared according to the booklet on the Ottawa site [24] and national guidelines [25] based entirely on up-to-date evidence of cervical cancer screening by the research team, and even how to perform screening was described by images. The contact number of the rst author and corresponding author was written in the booklet for more information. The Control group just received routine training about cervix cancer screening.
The rst telephone counseling session was provided by the author four weeks later for about ten min, to follow up and encourage them to carry out their questions about cervical cancer screening tests. The second session was held if participants tended and requested.
Six months after the intervention, the questionnaires were completed again by control and intervention groups by in-person interview. Adherence to the Pap-smear (action stage) was checked according to the health pro le documented by health care providers. The decision-aid-based counseling was presented at the end of the study to the control group to comply with the ethical principles.

Statistic analysis
The SPSS (ver 24) statistical software was used for data analysis. The mean and standard deviation were reported normal in the quantitative variables. First, the normality of quantitative data was investigated using Kolmogorov-Smirnov, which indicated normal distribution for all data. The independent t-test and chi-square test were used to compare the socio-demographic characteristics between groups. The Chi-square test was used to compare the stages of change before the intervention, and ordinal regression was used after the intervention. In order to compare the mean score obtained from SDM and DC between groups, an independent t-test was used before the intervention and ANCOVA test

Results
The present study was conducted on 154 women from April 2020 to June 2020 and follow-up continued until December 2020 (six-month follow-up). The mean (standard deviation) age of the intervention and control groups was 39.53 (10.1) and 38.44 (6.8), respectively. Most participants were housewives. There was no signi cant difference between the intervention and control groups in terms of the demographic and midwifery characteristics (Table 1).  Among 154 included participants (77 in each group), two individuals were withdrawn from control group (unwillingness to cooperate, n = 2), and one other was withdrawn from the intervention group (unwillingness to cooperate, n = 1) (Fig. 1).
Before the intervention, the comparison of the stages of behavior change in cervical cancer screening demonstrated that 57 women (74.0%) were in the pre-contemplation stage and 20 (26.0%) were in the contemplation stage in the intervention group. In the intervention group, 22 subjects (28.6%) entered the contemplation stage, 15 (19.5%) entered the preparation stage, and 19 (24.7%) entered the action stage (P < 0.0001) after the intervention (Table 2).  The mean score of SDM of the intervention group was signi cantly higher than that of the control group (Adjusted mean difference: 7.92 with 95% con dence interval: 5.59 to 10.25 (p < 0.001)). Further, the mean score of DC of the intervention group was signi cantly lower than that of the control group (Adjusted mean difference: -4.97 with 95% con dence interval: 8.04 to 1.09 (p < 0.001)), (Table 3). Table 3 The comparison of mean (SD) of SDM and decision con ict in the intervention and control groups, before and 6month after the intervention

Discussion
The results of the present study indicated that following decision-aid based counseling in the intervention group, 15 (19.5) subjects were in the stage of preparation for doing Pap smear and 19 (24.7) were in the action stage. While in the control group, 5 (6.5) women were in the preparation stage, and 7 In the present study, the mean score of SDM in the intervention group was signi cantly higher than that of the control group, and women in the intervention group had a sense of participation in decisionmaking, which is consistent with the study results of Jayoung Han (2018) indicated that the use of the SDM approach and the relationship between health care providers and clients increase the willingness to perform screening [29].
In addition, some studies [30][31][32] examined the impact of SDM on cancer-related preventive care. The results indicated the participants' satisfaction with healthcare provider's and physicians' participation in the decision-making process for preventative measures and even their cancer treatment decisions.
Further, these studies investigated the effect of decision-aid on SDM, improving knowledge, and reducing DC among patients. In the present study, the mean score of DC in the intervention group was lower than that of the control group. The results indicated that providing decision aid to guide patients for genetic testing to prevent breast cancer reduced the DC among women receiving decision aid [34].
Applying random allocation, the allocation concealment of the participants and relatively high sample size with different socio-demographic features were the strengths of the present study. The impossibility of nancing the screening costs and the lack of insurance support were among the factors in uencing women's decision-making for screening, which was one of the limitations of the present study.

Conclusion
The present study's ndings indicated the effect of decision-aid-based counseling on promoting SDM and reducing DC about cervical cancer screening, resulting in the informed decision-making and behavior change for performing screening. Therefore, it is recommended that midwives working in healthcare centers use decision-aid based counseling for cervical cancer screening as a complementary method along with routine training. Also, further research is required regarding e cacy of DA without counselling in different contexts in clinical practice.

Declarations
Ethics approval and consent to participate The study was approved by the ethics committee at the Tabriz University of Medical Sciences [Ethic code: IR.TBZMED.REC: 1398.319]. All participants signed a written informed consent form prior to their enrollment. Consent for publication not applicable.

Availability of data and materials
The datasets used and/or analysed during the current study available from the corresponding author on reasonable request.

Con ict of interest
The authors declare that they have no competing interests. self-e cacy," a program to develop and evaluate comprehensive Decision support services for women in gynecology clinics. None of the funding bodies participated in the study's design, in the collection, analysis, and interpretation of the data, or the writing of the manuscript Authors' contributions EMZ and EM conducted an intervention. All authors contributed to designing the study. AFKH and SH analyzed the data. EM drafted the manuscript in collaboration with co-authors (EMZ, AFKH, RN, SH) and was responsible for the overall management of the study. All authors critically revised the manuscript and read and approved its nal version. Flow chart