Background: Breast cancer and its treatment-related adverse effects are harmful to physical, psychological, and\nsocial functioning, leading to health-related quality of life (HRQoL) impairment in patients. Many programs have\nbeen used with this population for HRQoL improvement; however, few studies have considered the physical,\npsychological, and social health domains comprehensively, and few have constructed multimodal standard nursing\ninterventions based on specific theories. The purpose of this trial is to examine the effect of a health belief model\n(HBM)-based multimodal standard nursing program (MSNP) on HRQoL in female patients with breast cancer.\nMethods: This is a two-arm single-blind cluster randomized controlled trial (cRCT) in clinical settings. Twelve tertiary\nhospitals will be randomly selected from the 24 tertiary hospitals in Xi�an, China, and allocated to the intervention\narm and control arm using a computer-generated random numbers table. Inpatient female patients with breast\ncancer from each hospital will receive either MSNP plus routine nursing care immediately after recruitment\n(intervention arm), or only routine nursing care (control arm). The intervention will be conducted by trained nurses\nfor 12 months. All recruited female patients with breast cancer, participating clinical staff, and trained data collectors\nfrom the 12 hospitals will be blind with respect to group allocation. Patients of the control arm will not be offered\nany information about the MSNP during the study period to prevent bias. The primary outcome is HRQoL\nmeasured through the Functional Assessment of Cancer Therapy-Breast version 4.0 at 12 months. Secondary\noutcomes include pain, fatigue, sleep, breast cancer-related lymphedema, and upper limb function, which are\nevaluated by a visual analogue scale, the circumference method, and the Constant-Murley Score.\nDiscussion: This trial will provide important evidence on the effectiveness of multimodal nursing interventions\ndelivered by nurses in clinical settings. Study findings will inform strategies for scaling up comprehensive standard\nintervention programs on health management in the population of female patients with breast cancer.
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