Cervical cancer poses a significant threat to women's health and is a crucial public health issue. Early detection and treatment of cervical lesions and standardized management have emerged as essential pillars in the Global Cervical Cancer Elimination. The loop electrosurgical excision procedure (LEEP) is widely employed as a preferred approach for the diagnosis and treatment of precancerous cervical lesions and early invasive cervical cancer. Patients with high-grade cervical lesions are more prone to experiencing sexual dysfunction and psychological disorders after LEEP, attributed to the unique surgical site, physiological alterations, and psychological stress during the postoperative recovery process, thereby adversely affecting their quality of life. Currently, there is a shortage of research evidence regarding targeted intervention measures and long-term effect evaluations for sexual function quality and quality of life after LEEP for cervical lesions. In recent years, the health management model based on patient navigation has evolved into a novel modality for facilitating comprehensive tumor prevention and control. However, its effect in managing cervical lesions has yet to be comprehensively assessed. Therefore, we will design a randomized controlled trial to evaluate the impact of a patient navigation-based health management model on quality of life and sexual function after LEEP in patients with cervical lesions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
128
A patient navigation-based health management model for individuals with cervical lesions post-LEEP procedure, encompassing healthcare consultation services, personalized health guidance, and routine follow-up assessments.
Peking University People's Hospital
Beijing, Beijing Municipality, China
Quality of Life
The quality of life six months post-surgery was assessed using 36-Item Short Form Survey.
Time frame: six months after LEEP
Sexual function index
The Chinese version of the Female Sexual Function Index was used to evaluate the sexual function index at three time points: before LEEP, three months after LEEP, and six months after LEEP.
Time frame: before LEEP, three months after LEEP, and six months after LEEP
Anxiety
Anxiety symptoms were assessed using the Self-Rating Anxiety Scale at three-time points: before LEEP, three months after LEEP, and six months after LEEP.
Time frame: before LEEP, three months after LEEP, and six months after LEEP
Quality of Life
The quality of life was assessed using 36-Item Short Form Survey.
Time frame: before LEEP and three months after LEEP
Depression
Depression symptoms were assessed using the Self-Rating Anxiety Scale at three time points: before LEEP, three months after LEEP, and six months after LEEP.
Time frame: before LEEP, three months after LEEP, and six months after LEEP
Vaginal discharge
Patient-reported alterations in the volume, color, and odor of vaginal secretions.
Time frame: three and six months after LEEP
Recurrence rates
The recurrence of cervical lesions at three and six months post-surgery was evaluated using high-risk HPV testing, cytology test, and histopathological examination.
Time frame: three and six months after LEEP
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