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

BackgroundBreast 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.MethodsThis 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.DiscussionThis 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.Trial registrationChictr.org.cn ChiCTR-IOR-16008253 (April 9, 2016)

Effects of Health Belief Model based nursing interventions offered at home visits on lymphedema prevention in women with breast cancer: A randomised controlled trial

“…It has been shown in the literature that women are not aware of lymphedema before its development, are unable to recognise its symptoms and cannot take sufficient preventive measures (Thomas-MacLean, Miedema, & Tatemichi, 2005). Similar to the aims of the present study, Zhou et al (2016) examined effects of a comprehensive Health Belief Model (HBM) based nursing care program on the quality of life, lymphedema and other complications after breast surgery in their randomised controlled study on women in 2016.…”

Comparison of machine learning models for predicting the risk of breast cancer-related lymphedema in Chinese women

“…[6] The prevalence of BCRL varies from 5% to 77%. [6][7][8][9] The highest prevalence rate occurs within 3 years after the BC surgery, and the arm swelling rate increases almost 1% per year. [9][10][11] Breast cancer-related lymphedema can be a distressing side effect of BC and includes symptoms of swelling and progressive fibrotic skin changes, thus resulting in decreased quality of life (QOL) for the patient.…”