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| ID | Type | Description | Link |
|---|---|---|---|
| MBZX0102024007 | Other Grant/Funding Number | Beijing Research Association for Chronic Diseases Control and Health Education |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | The routine clinical outpatient follow-up protocol was implemented, and a postoperative rehabilitation health manual was provided to patients the day following LEEP surgery. Outpatient evaluations were subsequently conducted at 1 month, 3 months, and 6 months post-surgery. | |
| Intervention group | Experimental | A postoperative rehabilitation health manual was provided to patients the day following LEEP surgery. The nursing team, possessing over one year of clinical experience in gynecological nursing and psychological counseling, collaborated with clinicians to deliver health consultation services. They conducted in-person consultations lasting 10-15 minutes during routine outpatient follow-ups at 1, 3, and 6 months post-surgery. Patients were assessed based on the challenges encountered in postoperative rehabilitation and sexual life, and tailored guidance services were administered. Additionally, online counseling and guidance services were offered at 2, 4, or 5 months following surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient navigation-based health management | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | The quality of life six months post-surgery was assessed using 36-Item Short Form Survey. | six months after LEEP |
| Measure | Description | Time Frame |
|---|---|---|
| Sexual function index | 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. | before LEEP, three months after LEEP, and six months after LEEP |
| Anxiety |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenhui Ren, PhD | Contact | 86+18800124938 | rwh0617@outlook.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | Beijing Municipality | 100044 | China |
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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. |
| before LEEP, three months after LEEP, and six months after LEEP |
| Quality of Life | The quality of life was assessed using 36-Item Short Form Survey. | before LEEP and three months after LEEP |
| Depression | 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. | before LEEP, three months after LEEP, and six months after LEEP |
| Vaginal discharge | Patient-reported alterations in the volume, color, and odor of vaginal secretions. | three and six months after LEEP |
| Recurrence rates | The recurrence of cervical lesions at three and six months post-surgery was evaluated using high-risk HPV testing, cytology test, and histopathological examination. | three and six months after LEEP |