Cervical Intraepithelial Neoplasias
Conditions
Keywords
Loop electrosurgical excision procedure, Patient navigation, Quality of life, Sexual function
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.
Interventions
OTHERPatient 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.
Sponsors
Peking University People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life | six months after LEEP | The quality of life six months post-surgery was assessed using 36-Item Short Form Survey. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety | before LEEP, three months after LEEP, and six months after LEEP | 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. |
| Quality of Life | before LEEP and three months after LEEP | The quality of life was assessed using 36-Item Short Form Survey. |
| Sexual function index | before LEEP, three months after LEEP, and six months after LEEP | 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. |
| Vaginal discharge | three and six months after LEEP | Patient-reported alterations in the volume, color, and odor of vaginal secretions. |
| Recurrence rates | three and six months after LEEP | The recurrence of cervical lesions at three and six months post-surgery was evaluated using high-risk HPV testing, cytology test, and histopathological examination. |
| Depression | before LEEP, three months after LEEP, and six months after LEEP | 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. |
Countries
China
Contacts
Primary ContactWenhui Ren, PhD
Outcome results
None listed