Study design and participants
This study was carried out in the Breast Clinic of Arash Women’s Hospital, affiliated to Tehran University of Medical Sciences (TUMS) from first October 2020 to first April 2021. It was approved by the Institutional Research Board (Proposal Code: 99-1-259-47062) and the Ethics Committee (Approval ID: IR.TUMS.IKHC.REC.1399.113) of TUMS, Tehran, Iran. All participating women virtually signed the research informed consent before entering the study.
2.2. Study Outcomes
Our primary outcome was the amount of change in BCF and BCW before and after the intervention as measured by the research questionnaires. The secondary outcome was the association between the previous breast-related medical history of the patients and the amount of the basic and post-intervention BCF and BCW.
2.3. Inclusion and Exclusion criteria, Sample size calculation
As per the initial design of the research, participants were planned to be selected among the women attending the Breast Clinic of the hospital for screening purpose or for benign breast complaints. However, due to the restrictions created by the COVID-19 pandemic and the conversion of physical presence of patients to virtual modes of visits [13], the plans and the inclusion criteria changed relevantly. Therefore, participants were chosen among women who had attended the Breast Clinic during the last two years and had their phone numbers recorded in their files. Inclusion criteria consisted of age above 18 years, willingness to participate, a normal previous breast history and breast exam, and a normal or benign last breast imaging. Exclusion criteria comprised history of breast or any other cancer, new breast complaints, first-degree family history of BC, history of psychological disease, illiteracy, and inability to use virtual platforms.
We calculated the sample size based on the presumption of at least 3% change in BCF score after the intervention, considering a power of 80% and a confidence interval of 95%. Thus, a sample size of 102 women was estimated as appropriate.
2.4. Interventions, measurements, and tests
Records of the probably eligible women were picked out from the clinic files by the surgeon of the Breast Clinic. A trained staff called them, explained the study, and asked questions regarding the inclusion and exclusion criteria. Then, cases qualified for the study were enrolled after giving their virtual consent to participate.
First, all participants filled a survey which consisted of 34 items, including 11 queries about their general characteristics and medical histories, and 23 questions investigating their general psychological health, BCW and BCF. Among these 23 questions, the first two consisted of two of the three questions of the Lerman BC Worry Scale [14]. This scale [14] consists of three questions, inquiring about the rate of worrying, the effect on the patient functioning, and the effect on their mood. Lee et al [15] have adapted the first two in order to assess BCW in their cases, and we used these two questions accordingly.
The next seven questions were the Champion BC fear scale. This standard validated scale consists of eight questions [16], however in the Farsi translation the two last questions have been merged (resulting in seven questions) after undergoing validation and reliability tests by Moshki et al [17]. The last fourteen questions consisted of the hospital anxiety and depression scale (HADS) [18]. The Farsi version of HADS has previously been validated by Montazeri et al [19]. The first seven questions investigate the anxiety, and the following seven the depression of the patient. Questionnaires were made available to the patients via Google forms (https://www.google.com/forms/about/) which enabled them to answer the tests anonymously. Patients were only recognized by a number which was assigned by the link.
In the following steps, a series of messages consisting of twenty short videos, including animated texts and images about BC definition, clinical presentation, diagnosis, treatment, impact of early diagnosis on disease management, and follow-up were sent to all participants. The content and format of the messages had been prepared earlier for another study (Boroumand Sani et al. Forthcoming) in seven steps by a team consisting of two breast surgeons, a general surgeon, a gynecologist, an expert in validation of short-courses for medical knowledge and skills, three breast care nurses, two oncologic nurses, two general nurses, a medical student, a post-graduate student of medical education, two school teachers, two unrelated (non-medical or paramedical) students, and three housewives. To summarize the process), the steps for providing an appropriate content consisted of drafting the topics and details in a popular language, correction for missing topics and simplicity of language in two phases, adding people questions gathered through a preliminary study (Boroumand Sani et al. Forthcoming), drawing cartoon pictures, last two rechecks, and finalizing. Then, the content was converted to short interesting videos. In the previous study, the messages had been sent to a group of healthy women, and the rate of learning as well as the satisfaction of the participants had been assessed (Alipour et al. Forthcoming); both variables had shown a high level in the analysis.
In the present study, the messages were sent one by one on a daily basis by the WhatsApp mobile application privately to each participant, in order to make sure they received and opened every message. Around one month after sending the last film, another survey was filled by the participants via the same method, containing only the 23 questions of HADS, Lerman BCW scale and Champion BCF scale.
2.5. Statistical Analysis Methods
The statistical analyses were performed using IBM SPSS 24 (IBM Corp. Released in 2016. IBM SPSS Statistics for Windows, Version 24.0. Armonk, NY: IBM Corp). Data are presented as mean ± standard deviation for continuous variables and number with percentages for categorical variables.
The BCF score was calculated from the 7 questions of the Champion scale and the BCW score from the two questions of the Lerman scale. Depression and anxiety were estimated based on the seven first and second question of HADS, respectively; and the total HADS score was used as the general psychological health score.
For investigating the alterations in general psychological health, BCF and BCW, the Kolmogorov-Smirnov test did not confirm normal distribution. Therefore, analysis of these variables was performed by using the Wilcoxon test. The association of BCF and BCW changes with patient features was analyzed by using the Spearman’s correlation test for continuous variables, and Mann–Whitney U test or Kruskal-Wallis for the nominal variables.