Design, participants, and sampling
We used a cross-sectional study design. Convenience sampling was used to recruit women with breast cancer who had been admitted to the Tumor Hospital of Shaanxi Province or the First Affiliated Hospital of Xi’an Jiaotong University. Inclusion criteria were women newly diagnosed with breast cancer, aged 18 years or older, and Chinese speakers. The exclusion criteria were patients with other comorbid non-breast tumors, breast diseases, or cognitive disorders (screened by a blinded psychiatrist according to the criteria of the DSM-5.). The required sample size was estimated based on the metric of 5 to 10 participants per item in a validated instrument [23] to ensure sufficient power. Considering that the largest instrument used has 36 items, the appropriate sample size should be 180 to 360 patients.
Measurements
We used four existing instruments to assess HRQoL, resilience, PSS, and CS.
Functional Assessment of Cancer Therapy-Breast version 4.0
Patients’ HRQoL was measured by the 36-item Chinese Functional Assessment of Cancer Therapy–Breast version 4.0 (FACT-Bv4.0). Each item is rated on a 5-point Likert scale (0 = not at all, 4 = very much). The items are divided into five subscales (i.e., social/family well-being [SWB], physical well-being [PWB], functional well-being [FWB], emotional well-being [EWB], and breast cancer-specific [BCS] concerns) [24]. The FACT-Bv4.0 total score (ranging from 0 to 144) is the sum of the five subscales scores, with a higher score indicating better HRQoL [25]. A validation study of the Chinese FACT-Bv4.0 resulted in higher reliability (Cronbach’s a of the five subscales ranges from 0.59 to 0.85) and satisfactory validity [25]. In this study, the Cronbach’s a for the overall scale was 0.93 and, for each of the five subscales, it was 0.85 (PWB), 0.91 (SWB), 0.86 (EWB), 0.89 (FWB), and 0.70 (BCS).
Connor–Davidson Resilience scale
The 25-item Chinese Connor–Davidson Resilience Scale (CD-RISC) was used to measure psychological resilience. Responses are indicated on a 5-point Likert-type scale, ranging from 0 (not true at all) to 4 (true nearly all the time). Items are divided into three subscales—tenacity, self-reliance, and optimism. The total score ranges from 0 to 100, with a higher score reflecting higher resilience [26]. The Chinese CD-RISC also has high reliability (Cronbach’s a = 0.91) and satisfactory validity [26]. In this study, the Cronbach’s a values were 0.95 (CD-RISC), 0.92 (tenacity), 0.77 (self-reliance), and 0.88 (optimism).
Multidimensional Scale of Perceived Social Support
The 12-item Chinese Multidimensional Scale of Perceived Social Support (MSPSS) measures perceived support from family, friends, and significant others. Items are rated on a 7-point Likert scale (1 = very strongly disagree, 7 = very strongly agree). The total score is the sum of all items, ranging from 12 to 84, with a higher score indicating higher PSS [27]. The Chinese MSPSS has been well validated in university students (Cronbach’s a = 0.92) [28] and in patients with methadone maintenance treatment (Cronbach’s a = 0.92) [29]. In this study, the Cronbach’s a values were 0.93 (MSPSS), 0.91 (family support), 0.90 (friends support), and 0.93 (significant others support).
Medical Coping Mode questionnaire
The 20-item Chinese Medical Coping Mode questionnaire (MCMQ) was used to assess the CS of patients with breast cancer. It has three subscales, namely confrontation, avoidance, and resignation, with a higher subscale score indicating more confrontation, avoidance, or resignation, respectively [30]. The Chinese MCMQs have satisfactory psychometric properties (Cronbach’s a was 0.76) [30]. In this study, the Cronbach’s a for the three subscales were 0.70 (confrontation), 0.72 (avoidance), and 0.88 (resignation).
Data collection and analysis
Data were collected from March to December 2019. Patients were instructed to complete the questionnaires independently. If the patient had difficulties in reading or writing, a trained data collector read the items to the patient and recorded their responses.
Categorical variables were summarized using frequencies and percentages, while continuous variables were summarized using mean and standard deviation (SD). A one-sample t-test was utilized to compare the total score of the CD-RISC and MSPSS, and the three subscales scores of the MCMQ with the corresponding normative data. A multivariate linear regression analysis was performed to identify the influence of resilience, PSS, and CS on HRQoL when controlling for socio-demographics and clinical characteristics.
Structural equation modeling (SEM) was employed using the maximum likelihood bootstrapping method [30] to examine the mediating role of PSS and CS on the relationship between resilience and HRQoL. Standardized direct, indirect, and total effects, and R2 with a corresponding 95% bias-corrected confidence interval were estimated based on 1 000 random samples (bootstrapping method subsample) generated by computer [31, 32]. The mediating roles were examined via three stages [33]: 1) significant direct effects of resilience (independent variable), PSS, and CS (mediators); 2) significant direct effects of resilience on HRQoL (outcome variable); and 3) significant indirect effects of resilience and direct effects of PSS and CS on HRQoL. The model fit was examined with c2 value (desired significance P > 0.05), adjusted goodness-of-fit index (AGFI; desired value ³ 0.90), and root mean square error of approximation (RMSEA; desired value < 0.08) [32]. The data were analyzed using SPSS 25.0 and AMOS 21.0 (IBM Corp., Armonk, NY). A value of P < 0.05 (two-tailed) was considered statistically significant.
Ethical statement
The Human Research Ethics Committee of Xi’an Jiaotong University reviewed and approved the study protocol (2018-9800). Written informed consent was obtained from each patient before administering the questionnaire survey. Furthermore, the study conforms to the standards contained in the Declaration of Helsinki, as amended.