Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
Not Yet Recruiting
NCT Number: NCT06695871
Research on the Application of Patient Navigation-based Management Model of Patients After LEEP
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.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
25 year–50 year
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Patient navigation-based health management
OtherA 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 outcomes
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Quality of Life
Time frame: six months after LEEP
The quality of life six months post-surgery was assessed using 36-Item Short Form Survey.
Secondary outcomes
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Sexual function index
Time frame: 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.
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Anxiety
Time frame: 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.
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Quality of Life
Time frame: before LEEP and three months after LEEP
The quality of life was assessed using 36-Item Short Form Survey.
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Depression
Time frame: 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.
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Vaginal discharge
Time frame: three and six months after LEEP
Patient-reported alterations in the volume, color, and odor of vaginal secretions.
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Recurrence rates
Time frame: 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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Peking University People's Hospital
Other
Registry information
Official study title
Effect of Patient Navigation-based Health Management Model on Quality of Life and Sexual Function After LEEP in Patients With Cervical Lesions
Important dates
- Study start
- 2024
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Nov 19, 2024
- Registry last updated
- Nov 19, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.