It is a single-blinded, prospective, and parallel randomized controlled trial using baseline and follow-up assessments with two arms, namely the intervention and control groups, to measure the aim of the study, that is, the effect of CBBHEP on BSEP. The experimental group received CBBHEP and usual care for 12 weeks, whereas the control group received usual care only.

This study was approved by the Institute of Allied Health Sciences Research Ethics Committee at the National University of Medical Sciences with reference number IAHS/WMC/786/008/admin. The trial was registered at the World Health Organization registry site [31], with ID: ISRCTN-39194106.

The eligible participants were women aged 20‐37 years, able to speak verbally and write in the local Urdu language; their mother had a BC diagnosis and was receiving treatment at the oncology department of the hospital, had a smartphone with internet access, lived with family, were not pregnant, and were willing to take part in the study. Those who had previously participated in the breast awareness program and experienced known cognitive disorders were excluded. The study was conducted in the oncology department of the Hospital, Taxila, Pakistan, from August to November 2024. F test for analysis of covariance (ANCOVA) was used to determine the sample size using G. Power statistics, which were based on the effect size determined in a prior study (effect size=0.515) [28], an overall α=.01, power of .90, and attrition rate of 20% due to the sensitivity of the topic. An alpha value of .01 was selected to claim stronger evidence to conclude that an effect would be significant [32]. This resulted in a sample size of 72 participants. The intervention group required 36 subjects, and the control group required 36 participants.

The subjects were recruited from the oncology department with the help of a research assistant, who already planned follow-up visits for diagnosed patients. With the permission of the department head, during follow-up calls, the research assistant informed them about the BC awareness program for their daughters. Patient consent was already taken by the department for sharing important information so they can be contacted. In addition, a poster on breast health education was placed in the oncology department. All interested participants were screened for eligibility; 72 were eligible and provided signed consent to participate in the study. Participants were also matched on their age and educational levels. Matching was conducted sequentially as participants enrolled in the study. The minimum age was 20 years, and the maximum was 37 years, among the eligible participants. Age groups were matched within an acceptance range of 3 years. The minimum educational level was 10th grade. Levels were 10th grade, 12th grade, and 16th year of education upon graduation. Acceptance for educational matching was 10th grade, with 11th grade and 14th grade years of education considered for graduation.

After enrollment, 72 participants were randomized into 2 groups (1:1 ratio) by the principal investigator into intervention and control groups (36:36). The principal investigator randomly picked from the allocation concealment opaque envelope to assign the first subject to the assigned condition (experiment), and then, following subjects with similar matched pairs were placed in the second condition (control). Baseline assessment was done for each group after the random allocation into the intervention and control groups. The participants were blinded to the intervention and control groups until trial completion. The random assignment procedure adhered to the CONSORT (Consolidated Standards of Reporting Trials) flow diagram [33].

The CONSORT diagram showed the process of enrollment, random assignment into 2 groups, follow-up, and analysis phases of the study.

Reciprocal determination and the self-efficacy construct of SCT [21] were used for the creation and implementation of CBBHEP. It offers a thorough examination of the factors that influence behavior change because human behavior is the result of a dynamic interaction between personal, environmental, and behavioral factors [21]. The personal factors were knowledge, attitude, and self-efficacy, while environmental factors, with integration of the cultural identity concept, the PEN-3 culture model [22], and mother support, which leads to behavior toward BSEP (Table 1). The program was developed by the principal investigator and validated by 3 nurse educators, one software developer, and one female oncologist as experts. Experts were selected based on their working experience in oncology or research. An internet app for women’s health was created by a software developer. Before implementation, the principal investigator created learning materials for in-person classes, educational VDOs or multimedia, handouts, and infographics for mobile apps. The CBBHEP consisted of two parts: Part I, face-to-face sessions, and Part II, the mHealth app. In part-I, 3 face-to-face sessions (20‐25 min) were focused on educational as well as training assemblies to increase knowledge about BC & BSE, building a positive attitude and self-efficacy toward BSE through lecture on PowerPoint presentation in a group of 15‐20 women, structured small group discussion with 7‐10 participants and their mothers for 15‐20 minutes, and small group (7‐10 participants) skill demonstration for 5‐10 minutes, individual redemonstration training with mothers for 5‐10 minutes in a private setting, which leads toward BSE practice. Through behavioral capabilities, people learn knowledge and skills, through positive reinforcement from mothers, can handle barriers, through modeling, learn and develop self-efficacy, which is related to actual behavior performance. Part II included an infographic about information on BC and BSE, the importance of BSE, facts of BC, benefits of BSE video for skill demonstration, a monthly reminder for maintaining continuing in BSE behavior, and writing notes on BSE findings every month with supportive words from family members for the duration of 12 weeks. The mHealth app also helped to improve knowledge, build a positive attitude, and self-efficacy in performing BSE, which ultimately promotes BSE practice in high-risk women. Five experts independently evaluated the quality of the program, its lesson plan and materials, and the mobile app and revised materials after pilot testing on 10% of the required sample. In the pilot testing, interactive lectures, skill training, and small-group discussions were conducted with participants. Additionally, the Women’s Health app (WHA) was installed, and their opinions regarding its feasibility were gathered. The pilot testing was conducted before conducting the actual study, and these 10% of participants were not part of the actual study.

The control group received usual care only, whereas the experimental group received CBBHEP with usual care. There are no distinct data for high-risk women in hospital settings. BC and its risk factors and treatment options have been discussed as part of usual care through a pamphlet in the local (Urdu) language.

The principal investigator gave the intervention to trained research assistants. Assistants were selected because of their experience in oncology, and training was given about the educational process. Intervention was started with the control group on different dates from the experimental group, and follow-ups were conducted to avoid contamination of the subjects. A trained research assistant collected data (for BSEP at baseline and at 12 wk, and for follow-up and self-efficacy as a mediating factor for program monitoring at baseline, 4th, 8th, and 12 wk). The principal investigator, with the help of a trained research assistant, conducted follow-up visits at the 4th, 8th, and 12th weeks of intervention with individual participants (10‐15 min). An IT specialist collected participation feedback on WHA and mother support at the 4th, 8th, and 12th weeks. The IT specialist compiled the feedback from WHA into paper and shared it with the principal investigator for supporting discussion with participants (Table 2).

The Toronto BSE frequency and proficiency of practice scale [34] was adapted to measure the BSEP. The instrument was modified in terms of translation into the local Pakistani language and pretested on 30 high-risk women, the minimum sample size required. Cronbach α score was .90, indicating good reliability [35]. It is an 11-item scale that was used to assess BSEP in high-risk women using a five-point Likert scale (score 1 to 5, with 5 being a high score). The mean was obtained from the sum of the scores to determine the BSEP scale score. Higher scores and higher means were seen in this study as indicators of higher BSEP.

The instrument was translated into local language (Urdu) through backward translation techniques by Brislin [36] by followed steps; (1) Forward translation of original (English) version to Urdu version done by two experts (one official bilingual expert and one nurse educator with master’s degree in nursing); (2) an assistant professor of nursing (PhD in nursing,) who is fluent in both languages then checked the translated Urdu version for ambiguous or hard-to-understand wordings; (3) after that, two translators (one official translator and one nurse educator with a master’s degree in nursing) translated the Pakistani version backward to English while being “blinded” to the original English version; and (4) the initial version and modified version were reviewed for concept equivalence; an expert panel that involved all the experts in the translation process identified that the two versions of the instruments were equal and comprised no grammatical issues in meaning.

The self-efficacy scale for BSE [37] was used to monitor program effectiveness. Self-efficacy was selected because it acts as a mediating factor as well for promoting BSEP. The instrument was adapted with permission and translated into Pakistani (Urdu) and tested on high-risk Pakistani women [38]. The scale is scored on a range of 0 (cannot do at all) to 50 (moderately can do), to 100 (definitely can do). Self-efficacy monitoring was done by an experienced nurse educator as a nurse assistant. Additional training for measuring self-efficacy was given by the principal investigator. Nurse assistant did a self-efficacy assessment during follow-up at visits 4th, 8th, and 12th week by assessing individual participant BSE skill on the breast model and by filling a self-administered questionnaire. Participants’ self-efficacy score of 50% and above was considered effective for the intervention during follow-up. A total score of 90% and above was considered satisfactory self-efficacy in the performance of BSE among high-risk women at the end of the intervention, taken from empirical evidence [37]. Participants’ adherence to the program was demonstrated through feedback from the mHealth app.

Eligible participants were randomized into treatment and control groups. In both groups, baseline characteristics were compared using inferential analyses of independent 1-tailed t tests and chi-square tests. This study compared gain scores between the experimental and control groups using one-way ANCOVA to investigate the impact of the CBBHEP on BSEP. The statistical significance level was set at P<.01, and the mean was used to determine the significant difference between the mean BSEP, between the intervention and control groups at baseline and 12 weeks, and covariance as the pre-test score [39]. Paired sample t statistics were used to measure differences in the mean BSEP level within each group’s data at baseline and at the 12-week follow-up. Before the analysis, assumptions for the 1-way ANCOVA and paired 1-tailed t tests were computed. There was no missing data in the analysis.

After screening for eligibility, 72 subjects were eventually enrolled in the trial and randomized to one control group (n=36) and one intervention group (n=36; Figure 2). In the 12th week, the retention rate was 100%. At baseline, no discernible demographic differences were observed between groups. The average age was 28 (SD 5.72) years in both groups. The majority of the women in both groups had 10th grade (21/36, 58.3%) education and were mostly married (21/36, 58.3%; Table 3).

The mean was obtained from the sum of the scores obtained to determine the BSEP scale score. The mean (SD) of BSEP at baseline and 12-week measurement in the intervention group and control group were calculated (Table 4).

The impact of CBBHEP on BSEP between the experimental and control groups was measured using an ANCOVA through gain scores by controlling for the pretest score. This was the difference between the posttest and pretest scores as covariates [39]. The analysis showed that participants who took part in the 12th week of CBBHEP had significantly higher BSEP than those in the control group (F_1,69=58.908; P<.001), suggesting that the program had a significant impact on the intervention group’s improvement in BSEP (Table 5).

Paired sample t statistics were used to determine the mean difference in BSEP scores at baseline and 12 weeks within the groups (Table 6). The analysis also revealed that the BSEP of the experimental group at baseline and at 12 weeks differed significantly (t₃₅=7.214; P<.001), with BSEP being significantly greater at the 12th week than at baseline. Comparing the pretest and posttest BSEP pairwise for the control group revealed no discernible differences.

CBBHEP based on components of SCT [21] with integration of culture identity concept of PEN-3 model [22] was found to be effective in promoting BSEP behavior among high-risk women through personal factors such as knowledge of BC and BSE, building positive attitudes toward BSE, and improving the ability to perform BSE with mother support according to their cultural values and local language, as environmental factors concluded over literature support [25-27].

CBBHEP was developed to create awareness about BC and its screening measures, especially BSEP behavior. Pakistani women have many cultural barriers that affect the BC screening behavior, including BSE [16,17,40]. The cultural issues were related to female shyness, modesty, and misbeliefs about breasts as the most sensitive parts of their body that should be concealed or hidden all the time, and it’s only related to sexuality [16]. Embarrassment and an uncomfortable feeling to let practitioners do their breast examination and show it to female doctors for routine check-ups or tests, as it affects their confidentiality [17]. Misconceptions of BC about faith healers can cure the BC, and all lumps would be BC. A significant number also believed BC to be a result of God’s curse or evil eye [41].

The program was conducted in the local (Urdu) language and in a separate room where no men were given access to minimize the cultural barrier related to the confidentiality of women, to reduce shyness, and to maintain female modesty. Mothers of high-risk women were also part of the study because in Pakistani culture, women’s health-related issues are not openly discussed with male members of the family. Mothers were included because of their dominant role, especially for their daughters in families. During the interactive sessions, awareness about BC, screening measures such as BSE, and its importance was given through a PowerPoint presentation, and a VDO about the importance of breast health by religious women was shared to give them motivation and to make them aware that the breast is also like other parts of the body; it’s not only an organ related to sexuality, so breast health is also important for women. During a small discussion group session with mothers and high-risk women, common beliefs and misperceptions about BC were discussed to make their attitude positive for BC screening, especially BSE, by educating them about the facts of BC and the benefits of BSE for breast health awareness. During the training session, a VDO for the BSE skill was shared, and a breast model and simulator were used for demonstration. Redemonstration by each participant was taken on the breast model separately in a private room to maintain privacy and modesty. In WHA, information about BC, BSE, benefits of BSE, and facts about BSE were given for their reading as well, and a VDO on BSE skill was also part of the mHealth app.

According to empirical data, SCT-based educational intervention for promoting BSE was found to be effective [42]. Smartphone apps have been proven to improve BSE performance. A reminder alarm for the intimation of proper time for BSE could have a positive effect on BSEP because people spend a lot of time on their smartphones, and the lessons they learn from these apps, which include educational films, stick in their memory [43]. A smartphone-based educational intervention that included BSE knowledge tasks and monthly reminder messages was found to be 4 times higher BSEP in the intervention group than in the control group [42]. CBBHEP was more effective in promoting BSEP behavior as it was in the local language, including WHA. The PEN-3 model [22] was integrated into SCT [21] as a mother support because it has a potential source to educate and promote BC awareness and prevention among daughters. A mother may affect her daughter’s sense of self-efficacy in overcoming perceived barriers to BC prevention and early detection of BC symptoms in the form of informational support, such as advice or guidance, and by providing emotional support like empathy. Furthermore, exposure to a mother’s attitude and health behavior practices toward BC prevention may influence a daughter’s conception about the benefits and susceptibility of BC prevention. Thus, a mother’s knowledge about family history, modeling norms of healthy lifestyle practices [44], and support of health prevention behaviors could be influential in their daughter’s development of evolving behaviors that contribute to the awareness and prevention measures such as BC screening [45]. The program was acceptable for all participants, and they were motivated to continue the whole program after interactive sessions, as indicated by their feedback through WHA, which also indicates their acceptance of the program as an indication of a 100% retention rate. In the diary notes, participants shared their experiences with BSEP, including the fact that all results were normal, and that supportive remarks from my mother urged me to complete the BSE on time. “My mother reminded me of the BSE time and urged me to teach your sister the skill of doing BSE as well. This increased WHA’s efficacy and fostered a favorable attitude toward BC and BSE behavior. Monthly participant feedback via online data made it easier to understand the role of mothers and the efficacy of the intervention. Participants shared that after participating in this program, mothers’ attitudes were more positive: “She encouraged me to do BSE every month.” “After meeting with you, my mother said, “You must do BSE.” Social support-based educational interventions significantly improved women’s screening behavior for BC [46]. Thus, smartphone apps have been proven to improve BSE performance, but social support will close the gap toward behavior, and eventually accelerate behavior change. Studies show that social support plays a key role in health screening and behaviors [43]. Family support, especially from the mother, played a significant role in promoting BSEP behavior in their daughters. Every month, participants’ feedback through online data helped to understand the effectiveness of the intervention and the role of the mother more clearly.

Understanding BC and screening methods, such as BSE, for early awareness of BC symptoms was crucial. Research has shown that a lack of knowledge about BSEP is one of the reasons why people do not undertake it [47]. The results of the study were consistent with previous research showing that educational interventions that increase BSE knowledge through lectures, discussions, video sharing, or interactive demonstrations were effective in improving adult women’s BSEP [48,49]. CBBHEP was more informative as misperceptions about BC were communicated with facts. Twenty-minute smartphone-based teaching sessions were similarly successful in encouraging BSEP behavior in adult women. Understanding BC (classification, common site, risk factors, and screening measures), BSE methods (procedures, time to do, and observation), and BSEP demonstration comprised the educational intervention. The BSEP score of women who received the educational intervention was higher than that of the control group [29]. WHA, a part of CBBHEP, has an additional feature of making diary notes and sharing feedback to show acceptability and engagement in the intervention for adapting the behavior of BSEP.

Positive behaviors regarding BC screening measures were produced through attitude-focused interventions. By providing information about facts, at-risk groups, and the significance of screening procedures, CBBHEP also incorporated actions to foster a positive attitude toward BSEP. Additional conversations on their concerns about BC and BSE were held with the participants and their mothers in small groups of five to seven people. Women’s health apps received similar information. It was discovered that an educational intervention that encouraged a positive attitude toward BSEP worked well. Face-to-face group discussions during the educational interventions revealed a favorable attitude toward BSE, demonstrating a substantial increase in their views regarding BSEP following the group intervention [26,50]. CBBHEP was different as a positive attitude was enhanced through not only group discussion but also mother support.

Self-efficacy in conducting BSE was also assessed using a self-reported tool and at each follow-up session, including the fourth, eighth, and twelfth weeks of the intervention process. After the intervention, it consistently increased compared to the baseline. The program’s activities are comparable to those found in the literature that support the enhancement of self-efficacy. A health education intervention has been implemented to enhance women’s BSE performance. The intervention consisted of several techniques to boost women’s self-efficacy, such as verbal encouragement, group support, studying the educator’s conduct, and determining whether it is feasible. The self-efficacy and BSEP of the educational group were considerably greater than those of the control group [50]. Following the interactive in-person and online interventions, BSE self-efficacy levels increased significantly. The most significant predictor of behavioral change is self-efficacy [46]. CBBHEP was also effective in promoting self-efficacy with the addition of mother support, who continually encourages her daughters to perform BSE and teaches the steps to other daughters as well.

According to the study’s findings, a CBBHEP in the clinical practice of nurses could benefit from incorporating SCT into the concept of cultural identity. The program improved women’s knowledge, attitude, and self-efficacy for BSEP in their cultural context and values, which was crucial from a clinical standpoint for all aged women to be aware of BC and self-conscious of their breast health. Health education and family support, particularly from mothers, could raise BSEP to make it an alternative and successful approach to breast health awareness and early identification of BC symptoms. Mobile-based health education programs are the most popular and successful, and nurse-delivered interventions are required to apply these programs to high-risk women in culturally isolated communities by incorporating their culture. Future study could be conducted at multiple sites and in different communities for intervention effectiveness.

The study’s shortcomings include that it was conducted at a single site to explore phenomena further, and the program needed to be conducted in more settings. Second, some participants delayed the timely submission of their input to the WHAs, which may have been caused by internet problems or a lack of funds to purchase internet packages. To further understand the barriers and pinpoint contextual elements linked to future long-term preventive behavior, qualitative research should be planned.

The study made contributions to women’s breast health awareness in the following ways,

The BSEP in high-risk women was significantly affected by the CBBHEP as an intervention. At the 12-week follow-up, the BSEP results were significant, indicating that the intervention had an impact. The promotion of BSEP behavior was significantly impacted by family support, particularly from mothers. Nurses in comparable faith-based communities can perform such interventions.