Research on the Application of Patient Navigation-based Management Model of Patients After LEEP
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Patient navigation-based health management.
- Who it may be relevant to
- Registry conditions: Cervical Intraepithelial Neoplasias. Basic parameters: 25 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Patient Navigation-based Health Management Model on Quality of Life and Sexual Function After LEEP in Patients With Cervical Lesions
Overview
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
- Other 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.
Primary outcome measures
- Quality of Life [Time frame: six months after LEEP]
Secondary outcome measures (6)
- Sexual function index [Time frame: before LEEP, three months after LEEP, and six months after LEEP]
- Anxiety [Time frame: before LEEP, three months after LEEP, and six months after LEEP]
- Quality of Life [Time frame: before LEEP and three months after LEEP]
- Depression [Time frame: before LEEP, three months after LEEP, and six months after LEEP]
- Vaginal discharge [Time frame: three and six months after LEEP]
- Recurrence rates [Time frame: three and six months after LEEP]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Health services research
Study locations
China · 1 center
- Peking University People's Hospital — Beijing
Identifiers
NCT: NCT06695871 · 2024PHB398-001 · MBZX0102024007