Research on the Application of Patient Navigation-based Management Model of Patients After LEEP

Peking University

Status: Not yet enrolling

Conditions: Cervical Intraepithelial Neoplasias

Treatments: Other: Patient navigation-based health management

Study type: Interventional

Funder types: Other

Identifiers

NCT06695871

MBZX0102024007 (Other Grant/Funding Number)

2024PHB398-001

Details and patient eligibility

About

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.

Enrollment: 128 estimated patients

Sex: Female

Ages: 25 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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128 participants in 2 patient groups

Control group

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Other: Patient navigation-based health management