Development and Psychometric Validation of Patient-Reported Outcome Measures (PROMs BCC-20) for Assessing Comfort during Chemotherapy in Breast Cancer Patients.

Objective: The study aims to develop and psychometric validate Patient-Reported Outcomes Measures for Assessing Comfort during Chemotherapy in Breast Cancer Patients (PROMs BCC-20).

Methods: This study was conducted in two phases: 1) items were developed from the literature review and in-depth interviews, and 2) Exploratory factor analysis (EFA), Confirmatory factor analysis (CFA), and concurrent validity were performed to evaluate construct validity. The participants were cancer stage I-IIIC, adult females, performance status was assessed by Eastern Cooperative Oncology Group (ECOG) score ≤ 2 after receiving the second cycle of adjuvant chemotherapy and selected by purposive sampling method. For each group of EFA and CFA was 250 participants.

Result: Five hundred breast cancer patients during adjuvant chemotherapy were recruited from three tertiary cancer centers. A succession of EFA using principal axis factoring with Promax rotation revealed four dimensions yielded a seven factors solution, explaining a 60.07 percent variance. CFA contains 20 items with five factors; 1) social function, four items; 2) digestive function, three items; 3) emotional function, six items; 4) environmental function, three items; and 5) sleep quality, four items via maximum likelihood with bootstrapping indicated a good fit model (SRMR = 0.045, RMSEA = 0.040, CFI = 0.947, and TLI = 0.935). The Cronbach's alpha of 0.86 demonstrated strong internal consistency reliability. Pearson's correlation coefficient showed acceptable criterion validity.

Conclusion: The PROMS BCC-20 provides good psychometric properties and practical patients' direct reports of comfort in breast cancer patients during chemotherapy. The PROMs BCC-20 should be standardized for comfort measurement and tailor-made nursing care to provide patient satisfaction and good nursing outcomes.