Breast cancer is the most prevalent cancer among women worldwide, accounting for approximately 1 out of every 4 cancer diagnoses []. Despite advancements in breast cancer treatment, patients continue to experience significant psychological and physical burdens [,]. The wide range of subtypes of breast cancer adds to its complexity, as each has its distinct biological and genetic characteristics. This complexity leads to the need for highly individualized chemotherapy regimens tailored to factors such as hormone receptor status, human epidermal growth factor receptor 2 status, and genetic mutations [,]. Research also shows that patients with breast cancer often face, throughout the cancer journey, various unmet needs, particularly in areas such as physical and functional challenges, psychological support, and access to clear medical information [-]. More specifically, common issues include fatigue, pain, anxiety, fear of recurrence, difficulties in daily activity management, and a lack of coordinated care []. The needs of patients with breast cancer are also often more pronounced in younger patients and those with advanced cancer, especially during the transition from active treatment to survivorship [,].
Among patients with cancer, unmet needs have been linked to increased long-term distress and decreased quality of life (QOL) [,]. The symptom burden that arises from these unmet needs significantly influences the physical and psychological QOL of survivors of cancer []. Therefore, interventions to address these unmet needs and support the physical and psychological health of survivors of cancer are crucial at every stage of the cancer journey. However, in clinical settings, there can be physical constraints (eg, associated with staffing, space, and time limitations) to realize needs of all survivors of cancer, and attempts to address these needs may impose additional burdens on health care providers and systems. Given this reality, it is unsurprising that interest in using mobile apps in medical settings has been growing, enabling stakeholders to overcome challenges in addressing the needs of patients with cancer [].
Prior WorkGiven that breast cancer is the most common cancer (vs other cancer types) among women with a higher prevalence of unmet needs, many cancer-related apps are primarily targeted at this population []. Mobile health (mHealth) apps for patients with breast cancer have also become increasingly sophisticated, integrating various functionalities to support patients throughout their treatment and survivorship phases. Indeed, the extant apps for this type of cancer address a range of needs, including information on survivorship, upper limb dysfunction, sleep disturbances, nutrition, general health education, emotional support, energy balance challenges, and motivation []. Furthermore, they facilitate continuous monitoring, real-time feedback, and resource provision, which are essential in managing the complexities of breast cancer treatment []. mHealth apps have been reported to provide significant benefits for symptom management, patient engagement, and self-efficacy, which in turn are all critical for successful long-term outcomes [,]. mHealth-based intervention implementation has also been shown to positively influence QOL, stress, and weight management of survivors of breast cancer []. Particularly, these interventions enable patients with breast cancer to report symptoms and treatment-related side effects, promoting effective self-management [].
Despite the advances, current research on mHealth apps for patients with breast cancer features several gaps. For instance, most research-based apps focus on only 1 or 2 functions (eg, information delivery, adherence management, lifestyle enhancement, psychological support, or referral and linkage to resources) and thus fail to integrate all these features into a single app. In addition, most apps lack personalized recommendations based on individual patient data and face usability challenges, particularly for diverse populations [,]. Researchers have also posited that the effectiveness of the psychological support features of mHealth apps is subpar and that the specific needs of different breast cancer subtypes are underexplored []. Studies have traditionally focused on improving QOL [], often at the expense of investigating other critical clinical outcomes and the cost-effectiveness of these technologies in health care settings [].
TheoryThe development of our app, especially its structure and functionality, was guided by 2 pivotal theoretical frameworks, namely, the chronic care model (CCM) and the health belief model (HBM). The CCM emphasizes the importance of an integrated approach to managing chronic diseases such as breast cancer [,]. It advocates for a patient-centered approach that not only focuses on treating the disease but also on improving patients’ self-management capabilities and fostering long-term wellness []. The CCM informed our app’s design by its emphasis on continuous and integrative care that incorporates medical, psychological, and social support. For example, features such as real-time symptom tracking, personalized health education, and coordinated care planning were developed to align with the CCM’s core elements, ensuring that the app supports patients in managing their health proactively and holistically [,]. Meanwhile, the HBM was essential in addressing the psychological and behavioral aspects of health management within the app. The HBM posits that individuals’ health-related behaviors are influenced by their perceptions of the severity of a health condition, their susceptibility to the condition, the benefits of taking preventive action, and the barriers to doing so []. This model was particularly influential in the development of the app’s psychological support module, which aims to enhance patients’ motivation and confidence in condition management []. By incorporating tools that address perceived barriers (eg, educational resource provision) and highlighting the benefits of adherence to treatment and self-care routines, the app was designed to empower patients to take an active role in managing their health [,].
These frameworks provided a structured approach for the development of the app, ensuring that it not only meets the immediate medical needs but also supports long-term behavioral change and self-efficacy improvement among patients with breast cancer. The integration of CCM and HBM into the app enabled the delivery of proactive and personalized patient-centered care that is supportive of the complex psychological and physical needs of survivors of breast cancer.
Study AimThis study aimed to develop a self-management support app tailored to the needs of patients with breast cancer and verify its feasibility. Furthermore, we investigated whether the app would have a positive effect on patient self-efficacy and other psychological aspects compared to a control group—hereinafter treatment as usual (TAU) group—that did not use the app. In this study, we chose self-efficacy as the primary outcome based on the self-efficacy theory by Bandura [], which posits that individuals with higher self-efficacy are more likely to engage in self-management behaviors, leading to better health outcomes []. This theory is particularly relevant in chronic disease management, where patient engagement in treatment and self-care practices is crucial for long-term treatment success. Enhancing self-efficacy can empower patients to better cope with the physical and psychological burdens associated with breast cancer, thus improving their overall QOL.
Our research differs from previous work because it involved the incorporation of a broader range of features into a single app, providing a more holistic and culturally sensitive tool (vs other similar apps) tailored to the specific needs of patients with breast cancer. By addressing the identified shortcomings in the literature and using a multidisciplinary approach, we aimed to offer a comprehensive mHealth solution where other similar apps have focused on fewer aspects of care. Consequently, we developed 4 modules: an evidence-based medical information module, a psychological support module, a medication and appointment management module, and a patient inquiry module. On the basis of these aims, we proposed the following hypotheses:
Hypothesis 1: app use will significantly improve self-efficacy among patients with breast cancer compared to routine care.Hypothesis 2: app use will significantly improve QOL; mental adjustment to cancer; and psychological symptoms such as depression, anxiety, and menopausal emotional symptoms.Hypothesis 3: there will be a statistically significant association between the amount of change in the psychological variables that improved after app use.This study was a 12-week nonrandomized controlled intervention trial. This study used a nonrandomized design, selected mainly for convenience and logistical considerations. Randomized group assignment was deemed infeasible within the scope of this study due to resource and time constraints, as implementing randomization would have required additional infrastructure and staffing. While this design choice imposed certain limitations, it allowed for efficient recruitment and management of participants in real-world clinical settings. This study was reported in accordance with the TREND (Transparent Reporting of Evaluations with Nonrandomized Designs) statement, and a completed TREND checklist is provided in .
Ethical ConsiderationsThe study protocol was reviewed and approved by the Institutional Review Board of Chung-Ang University Hospital (2201-025-494). All participants provided written informed consent before enrollment in the study. Participant data were anonymized and stored on a secure server accessible only to the research team. Participants received approximately US $14 as compensation for each of their baseline and follow-up visits. The clinical trial registration was approved by the Clinical Research Information Service (KCT0007917).
Study Participants and RecruitmentUsing convenience sampling, 80 patients with pathologically proven clinical stage 0 to 4 breast cancer were recruited through an advertisement in hospital bulletins of the Digital Cancer Center at Chung-Ang University Hospital, located in Seoul, Korea, from January 2023 to June 2024. We focused on patients who voluntarily indicated their interest in participating in the study, and those who agreed to participate in the study were screened according to the following inclusion criteria: an adult female who was either undergoing active treatment for breast cancer or was a survivor of breast cancer. The exclusion criteria were as follows: current or history of uncontrolled medical diseases other than cancer; current or history of uncontrolled psychiatric diagnosis, including severe mood disorders, alcohol or substance use disorders, and intellectual disabilities; inability to engage in linguistic communication; and inability to use mobile apps on the phone.
Participants were assigned to the Cancer Manager (CAMA) group (ie, the experimental group) if they indicated a willingness to use the app and had access to a compatible smartphone, while those who did not meet these criteria were assigned to the TAU group. CAMA group participants used a mobile app, CAMA (HuDIT), designed to assist in the self-management of patients with breast cancer, and received routine care and education in the hospital; TAU group participants only received routine care and education. Routine care for patients with cancer aims to deliver comprehensive health care management services; does not encompass additional digital interventions; and typically includes regular medical follow-ups, symptom management, psychological support, nutrition counseling, palliative care, patient education, care coordination, monitoring and testing, access to emergency care, and social support services.
The eligibility screening and informed consent procedures were conducted by physicians (SMK, MKK, or HJK) or researchers (DSK or YJ). After the researchers provided explanations about the app, the app was installed on the patient’s device either by the researchers or by the patients themselves. Then, the researchers provided participants with appropriate instructions about the intervention, including how to use the app, the assessment schedule, and how to contact the Manager of the CAMA or research team. Patients were instructed to access the app daily and use it for at least 10 minutes. We administered the baseline and follow-up questionnaires from January 2023 to June 2024 via in-person visits or phone calls.
In total, 80 patients with breast cancer underwent eligibility assessment (), and some were excluded because of the following reasons: 6 (8%) declined to participate before enrollment, 1 (1%) had a major depressive disorder with agitation and suicidal ideation, and 1 (1%) was diagnosed with major neurocognitive disorder due to Alzheimer disease.
We enrolled 72 participants based on the inclusion and exclusion criteria, with 36 (50%) participants each in the experimental (CAMA) and TAU groups (). As aforementioned, group allocation was determined based on patients’ willingness to use the app and their access to compatible smartphones. This study did not use matching techniques for the nonrandomized assignment procedures. The CAMA group used the CAMA mobile app for 12 weeks, whereas the TAU group received no intervention during that period. Both groups maintained their usual treatment regimens throughout the 12 weeks. Clinical assessments of self-efficacy and other psychological aspects were conducted immediately after the beginning of the experiment (eg, right before patients downloaded the app and started using it) and immediately after the end of the experiment (eg, 1 day after the formal ending of the experiment).
App Development: CAMAOverviewThe CAMA app was developed to support patients with breast cancer in their self-management across different phases of the cancer journey, including at the time of diagnosis, during active treatment, and after treatment completion (ie, during the cancer survivorship phase). The CAMA app had three main functionalities: (1) it provided evidence-based digitalized information created by experts, (2) it managed patients’ medication and medical appointment schedules, and (3) it delivered a delayed question and answer (Q and A) system whereby patients can ask questions to health care professionals.
Evidence-Based Digitalized InformationFirst, oncologists, surgeons, psychiatrists, and psychologists were recruited to create informative content tailored to each phase of the cancer journey (). These digitalized contents, including videos, articles, images, and infographics, were registered on the website of the administrator of the CAMA app. The CAMA app provides personalized information to the patient depending on whether one is undergoing chemotherapy, surgery, or radiation therapy or is in the cancer survivorship phase. The digital contents covered topics such as information about breast cancer diagnosis, symptom management, preparation for treatment, management of treatment side effects, diet and nutrition, rehabilitation and exercise, psychological support, and information for caregivers.
Physicians and a nurse, a social worker, or a psychologist (referred to as the Manager) define the most relevant content according to the cancer-related condition (referred to as My Care Track), and the Manager registers the content on the administrator’s website. Alternatively, patients can search for and access information based on their requirements.
The My Care Track provides tailored content on a patient-specific basis, delivering helpful information regarding the patient’s cancer treatment stage. The contents are listed by date, and the app sends reminders and provides recommended content daily. For instance, the app considers factors such as the patient’s breast cancer subtype, time since cancer diagnosis, ongoing chemotherapy, or upcoming radiation therapy, providing essential daily guidance in concise, manageable pieces.
The Manager (referring to the nurse, social worker, or psychologist here) of the CAMA app is also responsible for coordinating the interactions between physicians and patients and the app and the offline treatment process. On the basis of previous research findings, barriers to the effectiveness of health care delivery through apps include a lack of feedback and support, a perception of the app as impersonal and cold, excessive or complicated information or intervention, discrepancies between the current treatment status and the information delivered, insufficient understanding of program use methods, and a lack of motivation []. The Manager of the CAMA app served to overcome these challenges, providing feedback and support, serving as a human communication channel, delivering tailored information or interventions, offering technical support for app use, and reinforcing motivation for app use. The Manager provided a communication channel between patients and health care professionals that was available during working hours (9 AM to 5 PM, Monday to Friday). In addition, every 2 weeks, the Manager texted participants to encourage the consistent use of the app. Every 4 weeks, the Manager called participants to check their frequency of use and how many days per week they used the app. Throughout the study, participants in the CAMA group interacted with health care professionals via the app an average of 0.44 (SD 0.93) times, with 15 interactions observed among the 34 participants in the CAMA group. Among the participants who completed the study, all met the minimum requirement of using the app for at least 10 minutes daily, resulting in a 100% engagement rate among these participants throughout the study procedures. Of 34 participants, 2 (6%) in the CAMA group who failed to meet this requirement or withdrew from the study were not included in the final analysis.
Patients’ Medication and Appointment SchedulesIn the CAMA app, the Manager can register the patient’s medication and medical appointment schedules through the website, or the patient can directly input these pieces of information into the app (). An alert is triggered when the scheduled time arrives, and once the patient completes their medication or appointment, they can mark it as completed in the app.
Patients can choose whether they would like to have face-to-face or remote consultations with the Manager and can use the app to ask questions to health care professionals, including attending physicians. When a patient asks a question, the health care professionals must review it and respond within a few days. This delayed Q and A system—not a live one—was introduced to alleviate the burden on health care professionals and ensure the sustainability of the app. Throughout the study, an average of 1.41 questions were asked per participant in the CAMA group through the delayed Q and A system (48 times among the 34 CAMA group participants).
Data CollectionSociodemographic and Clinical CharacteristicsThis study collected data on the following: sociodemographic characteristics (eg, age, years of education, and monthly family income); clinical characteristics, including cancer stage at enrollment, whether initial or recurring cancer at enrollment, performance status, pathological characteristics, receptor expression status (eg, hormone receptors such as estrogen receptor or progesterone receptor and human epidermal growth factor receptor 2), and triple-negative phenotype; cancer treatment types being received (eg, chemotherapy, surgery, and radiation therapy); and whether the patient is in the cancer survivorship phase.
Psychological Characteristics and User SatisfactionParticipants’ self-efficacy, QOL, mental adjustment to cancer, and psychological symptoms (ie, depression and anxiety) were assessed using validated scales at baseline and after the 12-week intervention. A satisfaction survey was also conducted among the participants who completed 12 weeks of CAMA use.
MeasurementsThe Eastern Cooperative Oncology Group scale [] was used to assess patient performance status based on physical activity. It was measured by health care providers and comprised 5 grades ranging from 0 (no symptoms) to 4 (completely bedridden throughout the day).
To evaluate self-efficacy, we used the 10-item Korean version of the Cancer Survivor Self-Efficacy Scale (CS-SES-K) [,]. This self-reported tool comprises 2 subscales and 10 items, namely, managing health problems (5 items) and seeking help and support (5 items). The items were rated on a scale ranging from 1 (not at all confident) to 10 (totally confident), and scores were calculated by adding the scores for each item, with higher scores indicating greater self-efficacy. The CS-SES-K demonstrated high reliability and validity when applied to Korean cancer survivors [], and the Cronbach α was 0.92 for the original tool [] and the Korean version []. In our study, the internal consistency of the CS-SES-K was also high, with a Cronbach α of 0.93.
To assess mental adjustment to cancer, we used the 29-item Korean version of the Mini-Mental Adjustment to Cancer (K-Mini-MAC) Scale. This 29-item self-reported tool categorizes cognitive and behavioral responses to cancer into 4 types: helplessness or hopelessness (8 items), anxious preoccupation (8 items), cognitive avoidance (4 items), and positive attitude (fatalism and fighting spirit; 9 items) [,]. Items were rated on a scale ranging from 1 (definitely does not apply to me) to 4 (definitely applies to me), with higher scores indicating a more pronounced inclination to exhibit a specific response. This scale demonstrated acceptable reliability and validity when applied to Korean survivors of cancer []. The Cronbach α range was 0.62 to 0.88 for the original tool [] and 0.72 to 0.86 for the Korean version []. In our study, the Cronbach α ranged from 0.74 to 0.89.
To evaluate QOL, we used the World Health Organization Quality of Life Brief Version (WHOQOL-BREF) [,]. This 26-item self-reported tool comprises 2 items measuring overall QOL and general health, along with 24 items divided into 4 subscales: physical health (7 items), psychological well-being (6 items), social relationships (3 items), and environmental aspects (8 items). Each item was scored on a scale ranging from 1 (not at all or very dissatisfied) to 5 (completely or very satisfied) with reverse-scoring items. Scoring was based on a specific formula, and higher scores on each subscale indicated a higher QOL in that respective domain []. This scale has demonstrated good validity, internal consistency, and test-retest reliability across various populations [,]. The Cronbach α range was 0.66 to 0.82 for the original tool [] and 0.90 for the Korean version []. In this study, the Cronbach α range was 0.67 to 0.84, indicating high internal consistency.
The 9-item Patient Health Questionnaire-9 (PHQ-9) was used to assess depression and depressive symptom severity [,]. This self-reported tool was responded to on a 4-point Likert scale ranging from 0 (none) to 3 (almost every day), and each item assessed how often a responder had experienced depressive symptoms in the past 2 weeks. The scores were calculated by adding the scores for each item, with higher scores indicating more severe depression. A previous study conducted with Korean psychiatric outpatients showed an internal consistency reliability of 0.81 and a test-retest reliability of 0.89, with significant concurrent validity []. Moreover, the Cronbach α was 0.89 for the original tool [] and 0.84 in this study.
To assess the degree of anxiety and anxiety symptoms, we used the 7-item Generalized Anxiety Disorder-7 (GAD-7) [,]. This self-reported tool was responded to on a 4-point Likert scale ranging from 0 (none) to 3 (almost every day), and each item assessed how often one had experienced anxiety symptoms in the past 2 weeks. The scores were calculated by adding the scores for each item, with higher scores indicating more severe anxiety. The GAD-7 demonstrated high validity and reliability for assessing anxiety in Korean psychiatric outpatients []. The Cronbach α was 0.92 for the original tool [] and 0.88 for the Korean version []. In this study, Cronbach α was 0.90, demonstrating high internal consistency.
The Menopause Emotional Symptoms Questionnaire (MESQ) measures the emotional symptoms experienced by menopausal women. This self-reported scale comprises 13 items rated on a 5-point scale ranging from 0 (never experienced) to 4 (experienced very frequently). The MESQ is a valid and reliable tool for screening and measuring emotional symptoms in Korean menopausal women []. This scale was included because many patients with breast cancer had hormone-positive breast cancer and experienced menopause-like feelings while undergoing antihormonal therapy. In this study, the Cronbach α of 0.94 suggested a high internal consistency for the scale.
To assess satisfaction with CAMA use, we created a 17-item satisfaction questionnaire based on questionnaires used in previous studies []. Each self-reported item was rated on a 5-point Likert scale ranging from 0 (strongly disagree) to 5 (strongly agree). An additional open-ended question was included for responders to provide comments to app developers and the medical team.
Sample Size CalculationThe target sample size was calculated using G*Power (version 3.1.9.7; Faul, Universität Kiel). A Wilcoxon signed rank test was considered necessary to compare the impact of CAMA use in a group of survivors of cancer. At the time of this study, no previous research had used the CS-SES-K as the primary outcome. Considering these descriptions and based on the effect size in a previous study evaluating the impact of a digital intervention on the self-efficacy of patients with cancer [], a significance level of 0.05, power of 0.85, and an effect size of 0.20 (medium), the sample size required was 60 participants. Given a 15% dropout rate, the goal was to recruit 72 participants, with 36 (50%) participants in each group, a number this study could reach.
Statistical AnalysesAll statistical analyses were performed using SPSS for Windows (version 28.0; IBM Corp). The analysis was restricted to data from participants who had no missing values and completed both the pre- and postintervention assessments, which means that a per-protocol analysis approach was used. Independent samples 2-tailed t tests and chi-square tests were used to compare baseline characteristics between the CAMA and TAU groups. To evaluate the effectiveness of the CAMA app on primary and secondary outcomes, a mixed-effects ANOVA was conducted, with group (CAMA vs TAU) as a between-subject factor and time (baseline vs follow-up) as a within-subject factor. The primary outcome was self-efficacy (CS-SES-K scores), while the secondary outcomes included psychological well-being (WHOQOL-BREF scores), mental adjustment to cancer (K-Mini-MAC Scale scores), depressive symptoms (PHQ-9 scores), anxiety (GAD-7 scores), and menopausal emotional symptoms (MESQ scores). Pearson correlation analyses were conducted within the CAMA group to explore the relationships between changes in psychological outcomes. Moreover, we performed Pearson correlation analyses for scale scores that demonstrated a statistically significant improvement from baseline to follow-up.
As mentioned in the Methods section, 80 patients with breast cancer underwent an eligibility assessment (), but only 72 (90%) were enrolled, and 66 (82%) completed the study (completion rate: 66/72, 92%). In the CAMA group, discontinuation resulted from noncompliance with CAMA use in 2 participants; in the TAU group, 4 patients did not undergo any follow-up assessments (discontinuation rates: 2/36, 6% in the CAMA group and 4/36, 11% in the TAU group). Throughout the study period, no adverse events associated with the CAMA intervention were observed.
Results of the independent samples 2-tailed t test and chi-square test indicated no significant differences in the demographic factors between the CAMA and TAU groups at baseline (). Similarly, the CAMA and TAU groups exhibited no significant differences at baseline in the subscale and total scores for the CS-SES-K; the subscale scores for the WHOQOL-BREF and K-Mini-MAC Scale; and the total scores for the PHQ-9, GAD-7, and MESQ ().
Table 1. Sociodemographic and clinical characteristics at baseline.VariablesCAMAa group (n=34)TAUb group (n=32)t test (df=64)χ2 (df)P valueSociodemographic variablesaCAMA: Cancer Manager.
bTAU: treatment as usual.
cNot applicable.
dECOG: Eastern Cooperative Oncology Group.
eER: estrogen receptor.
fPR: progesterone receptor.
gHER2: human epidermal growth factor receptor 2.
Comparison of Changes in Clinical Scale Scores Between the CAMA and TAU GroupsThroughout the intervention period, the CAMA group (vs the TAU group) demonstrated observable improvements in the following scale scores: the seeking help and support subscale of CS-SES-K (F1,64=5.09; P=.03), the psychological well-being subscale of WHOQOL-BREF (F1,64=5.48; P=.02), the anxious preoccupation subscale (F1,64=5.49; P=.02) and the positive attitude subscale (F1,64=5.44; P=.02; ) of the K-Mini-MAC Scale, PHQ-9 (F1,64=4.83; P=.03), GAD-7 (F1,64=5.48; P=.02), and MESQ (F1,64=4.30; P=.04; ). No significant differences were observed between the 2 groups in total or subscale scores for the other scales.
Table 2. Differences in the mean scores for the self-efficacy and psychological scales at baseline.Psychological scales and variablesCAMAa group (n=34), mean (SD)TAUb group (n=32), mean (SD)t test (df=64)P valueCS-SES-KcaCAMA: Cancer Manager.
bTAU: treatment as usual.
cCS-SES-K: Korean version of the Cancer Survivor Self-Efficacy Scale.
dWHOQOL-BREF: World Health Organization Quality of Life Brief Version.
eK-Mini-MAC: Korean version of the Mini-Mental Adjustment to Cancer.
fPHQ-9: Patient Health Questionnaire-9.
gGAD-7: Generalized Anxiety Disorder-7.
hMESQ: Menopause Emotional Symptoms Scale.
Table 3. Comparison of score changes in the self-efficacy and psychological scales between the Cancer Manager (CAMA) and treatment as usual (TAU) groups.VariablesCAMA group (n=34), mean (SD)TAU group (n=32), mean (SD)Group × time effect (mixed ANOVA)
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