Clinical trial NCT06695871: Research on the Application of Patient Navigation-based Management Model of Patients After LEEP
Official title: Effect of Patient Navigation-based Health Management Model on Quality of Life and Sexual Function After LEEP in Patients With Cervical Lesions
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cervical Intraepithelial Neoplasias
Keywords: Loop electrosurgical excision procedure
Patient navigation
Quality of life
Sexual function
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2024-11-19
Enrollment: 128
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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 criteria: 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 outcomes:
measure: Quality of Life
timeFrame: six months after LEEP
Secondary outcomes:
measure: Sexual function index
timeFrame: before LEEP, three months after LEEP, and six months after LEEP
measure: Anxiety
timeFrame: before LEEP, three months after LEEP, and six months after LEEP
measure: Quality of Life
timeFrame: before LEEP and three months after LEEP
measure: Depression
timeFrame: before LEEP, three months after LEEP, and six months after LEEP
measure: Vaginal discharge
timeFrame: three and six months after LEEP
measure: Recurrence rates
timeFrame: three and six months after LEEP
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
References: