Research on the Application of Patient Navigation-based Management Model of Patients After LEEP

NCT06695871 · tracked via the Priya Life Science China tracker

Sponsor

Peking University People's Hospital

Phase

Not applicable

Started

2024-12-01

Last updated

2024-11-19

Condition(s) studied

Cervical Intraepithelial Neoplasias

Investigational drug(s) / intervention(s)

Patient navigation-based health management

Patient navigation-based health management: 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.

Study summary

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.

Eligibility

Sex

FEMALE

Min age

25 Years

Max age

50 Years

Healthy volunteers

Inclusion Criteria: * Individuals aged between 25 and 50 years; * LEEP will be conducted following clinical evaluation; * No intention to conceive within the subsequent year; * Proficiency in utilizing social media platforms, such as WeChat, is required; * Patients must be capable of providing informed consent to participate in the study and willing to engage in long-term follow-up. Exclusion Criteria: * Individuals who are widowed, separated, or experiencing atypical sexual activity due to reasons related to their spouse. * Presence of genital tract malformations. * A history of neurological disorders, such as stroke or epilepsy, or a history of psychiatric conditions, such as depression. * Patients with other significant illnesses that could impact the long-term follow-up of the study.

Primary outcome measure(s)

Quality of Life — six months after LEEP
The quality of life six months post-surgery was assessed using 36-Item Short Form Survey.

Trial sites (1)

Facility	City	Region	Status
Peking University People's Hospital	Beijing	Beijing Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06695871 on ClinicalTrials.gov ↗ ← All trials in China