title: Effectiveness of a multimodal standard nursing program on health-related quality of life in Chinese mainland female patients with breast cancer: protocol for a single-blind cluster randomized controlled trial.
abstract: Breast cancer and its treatment-related adverse effects are harmful to physical, psychological, and social functioning, leading to health-related quality of life (HRQoL) impairment in patients. Many programs have been used with this population for HRQoL improvement; however, few studies have considered the physical, psychological, and social health domains comprehensively, and few have constructed multimodal standard nursing interventions based on specific theories. The purpose of this trial is to examine the effect of a health belief model (HBM)-based multimodal standard nursing program (MSNP) on HRQoL in female patients with breast cancer.
  
  
  
  This is a two-arm single-blind cluster randomized controlled trial (cRCT) in clinical settings. Twelve tertiary hospitals will be randomly selected from the 24 tertiary hospitals in Xi'an, China, and allocated to the intervention arm and control arm using a computer-generated random numbers table. Inpatient female patients with breast cancer from each hospital will receive either MSNP plus routine nursing care immediately after recruitment (intervention arm), or only routine nursing care (control arm). The intervention will be conducted by trained nurses for 12 months. All recruited female patients with breast cancer, participating clinical staff, and trained data collectors from the 12 hospitals will be blind with respect to group allocation. Patients of the control arm will not be offered any information about the MSNP during the study period to prevent bias. The primary outcome is HRQoL measured through the Functional Assessment of Cancer Therapy-Breast version 4.0 at 12 months. Secondary outcomes include pain, fatigue, sleep, breast cancer-related lymphedema, and upper limb function, which are evaluated by a visual analogue scale, the circumference method, and the Constant-Murley Score.
  
  
  
  This trial will provide important evidence on the effectiveness of multimodal nursing interventions delivered by nurses in clinical settings. Study findings will inform strategies for scaling up comprehensive standard intervention programs on health management in the population of female patients with breast cancer.
  
  
  
  Chictr.org.cn ChiCTR-IOR-16008253 (April 9, 2016).
authors: Xi'an Jiaotong University Health Science Centre, No. 76 Yanta West Road, Xi'an, Shaanxi, 710061, China.
authors: Kaina
authors: K
authors: Zhou
authors: Liverpool School of Tropical Medicine, Pembroke Place, Liverpool, L3 5QA, UK.
authors: Duolao
authors: D
authors: Wang
authors: Xi'an Jiaotong University Health Science Centre, No. 76 Yanta West Road, Xi'an, Shaanxi, 710061, China.
authors: Xiaole
authors: X
authors: He
authors: Xi'an Jiaotong University Health Science Centre, No. 76 Yanta West Road, Xi'an, Shaanxi, 710061, China.
authors: Lanting
authors: L
authors: Huo
authors: Xi'an Jiaotong University Health Science Centre, No. 76 Yanta West Road, Xi'an, Shaanxi, 710061, China.
authors: Jinghua
authors: J
authors: An
authors: Xi'an Jiaotong University Health Science Centre, No. 76 Yanta West Road, Xi'an, Shaanxi, 710061, China.
authors: Minjie
authors: M
authors: Li
authors: Xi'an Jiaotong University Health Science Centre, No. 76 Yanta West Road, Xi'an, Shaanxi, 710061, China.
authors: Wen
authors: W
authors: Wang
authors: Xi'an Jiaotong University Health Science Centre, No. 76 Yanta West Road, Xi'an, Shaanxi, 710061, China. roselee@mail.xjtu.edu.cn.
authors: Xiaomei
authors: X
authors: Li
mesh_terms: D044466:Asian People; D001943:Breast Neoplasms / Q000451:nursing* / Q000523:psychology*; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D011788:Quality of Life; D012107:Research Design; D016037:Single-Blind Method
keywords: Breast cancer; Cluster randomized controlled trial; Health belief model; Health-related quality of life; Multimodal standard nursing program; Study protocol