This study used a cross-sectional design and was conducted from February 2023 to July 2023.

Ethical approval was obtained from the ethics committee of Sun Yat-sen University Cancer Center (B2023-700-01). The procedures used in this study adhere to the tenets of the Declaration of Helsinki, which emphasize respect for the dignity, autonomy, and privacy of research participants; the minimization of potential risks and the maximization of possible benefits; and the requirement for voluntary and informed consent prior to participation. Participants’ personal data were treated with strict confidentiality, and their rights and well-being were protected throughout the research process. Participants did not receive any compensation for their participation in this study.

A convenience sampling method was used to recruit patients with breast cancer who sought medical care at a specialized oncology hospital in Guangdong Province, China, between February 2023 and July 2023. Inclusion criteria were as follows: (1) being aged 18 years or older; (2) first-time pathological diagnosis of stage 0-3 breast cancer; (3) no prior breast cancer–related treatment; and (4) an educational level of primary school or higher. Exclusion criteria included: (1) metastatic or recurrent breast cancer; (2) a history of other major organ diseases or malignancies; and (3) a diagnosis of psychiatric disorders or cognitive impairment. Written informed consent was obtained from all participants.

According to the empirical sample size calculation method based on regression analysis [17], the sample size should be 5 to 10 times the number of variables. The predictive factors included self-disclosure, social support, tumor stage, type, and a total of 23 influencing factors. Considering a 20% rate of invalid responses, the minimum sample size was calculated as 23×10/(1–0.20)=287.5 cases. Therefore, the minimum required sample size for this study was determined to be 288 cases.

For patients who met the inclusion and exclusion criteria, data collection was conducted after hospital admission and pathological diagnosis, but prior to the initiation of treatment. Upon obtaining written informed consent, a professionally trained research staff member distributed the questionnaires and guided participants in their completion. After completion, the researcher checked each questionnaire for completeness. Prior to the start of the study, this staff member received comprehensive training on research ethics, questionnaire content, completion guidelines, and communication skills with patients, ensuring effective interaction and the provision of appropriate support throughout the process.

To ensure data quality and minimize potential bias, standardized procedures were implemented during questionnaire administration. The research staff members received structured training on research ethics, questionnaire content, standardized instructions, and communication skills prior to data collection. All questionnaires were completed independently by participants, and responses were checked for completeness without influencing participants’ answers. Specifically, the researcher responsible for questionnaire administration was not provided with information about the patients’ treatment plans or clinical conditions during data collection, thus minimizing potential bias in the data collection process.

Data analysis was conducted by an independent researcher with extensive experience in clinical research and professional training in oncology and statistics. The dataset was deidentified prior to analysis to ensure confidentiality and objectivity.

All statistical analyses were performed using SPSS version 25.0 (IBM Corp), with a significance level set at α=.05; P values less than .05 were considered statistically significant. Descriptive statistics were used to characterize participants’ sociodemographic and clinical characteristics. Univariate analyses or bivariate correlations were initially conducted to identify potential factors associated with levels of FCR. ANOVA was used to examine differences in FCR scores across various sociodemographic and clinical characteristics (eg, education level, marital status, employment status, and household income). Pearson correlation analysis was performed to assess the relationships among self-disclosure, social support, and FCR in patients with breast cancer.

Variables demonstrating statistical significance in univariate analyses were subsequently entered into a multivariate regression model. A multiple linear regression analysis was conducted to identify independent predictors of FCR. The squared correlation coefficient (R²) was used to indicate the proportion of variance in the dependent variable that could be explained by the independent variables. A P value of 0.05 was considered the threshold for statistical significance.

A total of 362 patients met the inclusion criteria and provided informed consent. As 12 patients refused to participate in the study, 350 patients finally completed the questionnaire, resulting in a loss rate of 3.31%. The descriptive data on sociodemographic and clinical characteristics, as well as Distress Disclosure Index and MOS-SSS-CM scores, are summarized in Table 1. A total of 350 patients with breast cancer, aged between 25 and 77 years (mean age: 45.39, SD 9.68), were included in the study, with 99.1% (n=347) being female. The majority reported a per capita monthly household income above 5000 RMB (US $689.22). Financial concerns were prevalent, with 63.7% of patients experiencing some degree of economic burden and 15.7% (n=55) reporting severe financial stress. Additionally, 55.7% (n=195) rated their sleep quality as average. The mean (SD) scores for self-disclosure and social support were 38.86 (9.31) and 70.57 (14.04), respectively. The mean FCR score among patients with breast cancer was 33.43 (SD 8.00), with the physical health dimension (18.11, SD 4.12) scoring higher than the social or family dimension (15.32, SD 4.66). Notably, 48.3% (n=169) of patients reported experiencing fear of recurrence prior to the initiation of treatment.

The results of the ANOVA indicated that there were statistically significant differences in FCR related to age, the average age of the youngest child, the average age of all children, monthly per capita household income, financial burden, place of residence, family relationships, occupation before diagnosis, and sleep status (P<.05). The Pearson correlation analysis revealed that both self-disclosure (r=−0.394; P<.01) and social support (r=−0.393; P<.01) were significantly and negatively associated with fear of cancer recurrence (Table 1).

A standard enter method linear regression analysis was performed, with FCR set as the dependent variable. Independent variables were those found to be statistically significant (P<.05) in univariate and correlation analyses, including patient age, average age of the youngest child, average age of all children, monthly per capita household income, financial burden, place of residence, family relationship, occupation before diagnosis, sleep quality, self-disclosure, and social support. A significant regression equation (F_11,337=15.42; P<.001) was found, with an R² of 0.335 (Table 2). Younger age, poorer sleep quality, greater financial burden, lower self-disclosure, and lower social support were independently associated with higher FCR levels. Lower household income showed a trend toward association with higher FCR (P=.05).

This study found that FCR was a prevalent psychological issue among patients newly diagnosed with breast cancer prior to treatment, with approximately 50% experiencing clinically significant levels of fear. This proportion was lower than that reported by Han et al [24] but higher than that found by Li et al [25], suggesting heterogeneity in FCR across different patient groups. The discrepancy may be due to differences in study populations and timing of assessment. Han et al [24] focused on patients undergoing chemotherapy, during which FCR may be intensified by side effects and prolonged stress (including financial, occupational, and familial stressors). In contrast, the participants in this study were at the pretreatment stage, not yet exposed to treatment-related stressors, which may explain their relatively lower FCR. Li et al’s [25] study mainly involved postoperative patients. In our study, patients were newly diagnosed, facing difficulty accepting the diagnosis and perceiving uncertainty about future treatment, potentially contributing to high FCR. These findings highlight the importance of early psychological intervention for newly diagnosed patients.

This study identified age as a significant factor influencing FCR in patients with breast cancer (P<.001), consistent with the findings of Zhang et al [26]. Younger patients tend to be more concerned with body image, and treatment-related changes, such as hair loss from surgery or chemotherapy, may trigger feelings of inferiority or depression, exacerbating FCR.

Sleep quality was significantly associated with FCR in the multivariate analysis, with poorer self-reported sleep linked to higher levels of fear [27]. However, as sleep quality was assessed using a single self-reported item and the study used a cross-sectional design, the directionality of this association cannot be determined. It is possible that sleep disturbances and FCR are interrelated through shared psychological mechanisms, such as heightened cognitive arousal or stress sensitivity. These findings suggest that sleep quality may be an important factor to consider when assessing psychological vulnerability in newly diagnosed patients. Future longitudinal studies using standardized sleep measures (eg, the Pittsburgh Sleep Quality Index) are needed to further clarify the nature and direction of this relationship.

Both univariate and multivariate analyses suggested that lower household income tended to be associated with higher levels of FCR; however, this association did not reach conventional statistical significance in the multivariate model (P=.054). In contrast, perceived financial burden remained a significant independent predictor of FCR, with patients reporting moderate or severe financial burden exhibiting higher FCR levels. These findings are consistent with the results reported by Niu et al [14]. Possible explanations include the substantial cost of cancer treatment and the additional financial concerns related to potential recurrence. Patients facing greater economic strain may experience heightened anxiety and uncertainty about future treatment expenses, which could amplify fear of recurrence. Notably, patients with medical insurance reported lower levels of FCR compared with those who paid out-of-pocket, suggesting that financial protection mechanisms may play a buffering role in psychological adaptation. Given that patients with breast cancer often require costly adjuvant therapies such as chemotherapy or radiotherapy, limited reimbursement for anticancer medications may exacerbate financial stress among economically vulnerable patients. Therefore, health care providers should assess patients’ financial situations when formulating treatment plans, offer cost-effective therapeutic options when feasible, and provide targeted psychological support. At the policy level, further strengthening the medical insurance system and expanding coverage for major illnesses may help alleviate financial burden and indirectly reduce FCR.

This study found a significant negative correlation between self-disclosure and FCR. Self-disclosure, typically expressed through verbal communication of one’s thoughts and emotions, serves both as a personal coping mechanism and a psychological intervention strategy. It has been shown to alleviate psychological distress and improve quality of life [28]. Prior research supports these findings. Xu et al [11] reported that effective communication helps patients correct misconceptions about recurrence and fosters healthier beliefs, thereby reducing FCR. In a controlled trial by Chen et al [12], a self-disclosure intervention significantly increased disclosure levels, reduced negative emotions, and lowered FCR in postoperative patients with breast cancer undergoing chemotherapy. Another study found that enhancing spousal self-disclosure also reduced FCR [13]. This may be due to the fact that individuals with higher levels of self-disclosure receive more external feedback—such as encouragement, experiential guidance, or health-related information—which improves their understanding of the disease and relieves emotional stress. Sharing one’s illness experience and feelings can also enhance emotional support. Therefore, clinical staff should encourage newly diagnosed patients to engage in active and meaningful communication, such as journaling or peer discussion, to express their thoughts and expectations. This practice can enhance self-disclosure, help patients cope with stress, and assist them in making informed treatment decisions.

Social support was significantly and negatively correlated with FCR, encompassing both the physical and social or family dimensions. This finding is consistent with the results of Niu et al [14] and Yu et al [15]. A meta-analysis also demonstrated that low levels of social support are associated with increased FCR in patients with breast cancer, while higher levels of support promote positive health perceptions and reduce stress-related recurrence fears [16]. As a protective factor, social support facilitates emotional regulation through interpersonal interaction and helps alleviate symptom distress and fear of recurrence [27]. In the context of FCR, social support acts as a “buffer,” mitigating the negative psychological impact of stressful events [29]. Strong social support not only reduces symptom sensitivity and psychological distress, such as anxiety and depression, but also enhances mental health, decreases FCR, and improves quality of life. Furthermore, it enables patients to approach treatment and recovery with greater positivity and optimism.

This study has several limitations. First, participants were recruited from a single tertiary cancer hospital in Guangzhou using convenience sampling, which may introduce selection bias and limit generalizability. Patients in a specialized urban cancer center may differ from those in community or rural settings in terms of socioeconomic status, access to insurance, and psychosocial resources. Given Guangzhou’s developed health care infrastructure, findings related to financial burden may be influenced by regional insurance policies and economic conditions. In contrast, associations between psychosocial factors (eg, self-disclosure and social support) and FCR may reflect more broadly applicable cognitive and interpersonal processes. Multicenter studies across diverse regions are needed to confirm the generalizability of these findings. Second, the study captured self-disclosure, social support, and FCR at a single time point. Consequently, it lacks longitudinal data to assess how these psychological variables change over time or impact patients across different stages of treatment and disease progression. Third, the cross-sectional design precludes causal inference. Although significant associations were identified between self-disclosure, social support, financial burden, and FCR, the temporal sequence of these variables cannot be determined. Longitudinal or interventional studies are needed to clarify these potential causal pathways. Fourth, sleep quality was assessed using a single self-reported item rather than a validated instrument, which may introduce reporting bias and limit measurement accuracy. Future studies should use standardized measures, such as the Pittsburgh Sleep Quality Index, to provide a more comprehensive assessment.

Prior to initial treatment, approximately 50% of patients newly diagnosed with breast cancer reported high levels of FCR. Younger age, poorer sleep quality, greater financial burden, lower self-disclosure, and lower perceived social support were associated with higher FCR levels. These findings highlight the importance of early identification of patients at risk for elevated FCR. Although causal relationships cannot be established due to the cross-sectional design, the results provide preliminary evidence to inform future longitudinal and interventional studies aimed at examining whether enhancing psychosocial resources and addressing sleep and financial concerns may help reduce FCR and improve psychological adaptation during treatment decision-making.