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

NCT ID: NCT06695871

Last Updated: 2024-11-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2025-12-31

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.

Conditions

Cervical Intraepithelial Neoplasias

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention group

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.

Group Type: EXPERIMENTAL

Patient navigation-based health management

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ren Wenhui

Assistant research fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking University People's Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Wenhui Ren, PhD

Role: CONTACT

rwh0617@outlook.com

86+18800124938

Facility Contacts

Wenhui Ren, PhD

Role: primary

rwh0617@outlook.com

86+18800124938

Other Identifiers

MBZX0102024007

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2024PHB398-001

Identifier Type: -

Identifier Source: org_study_id