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

NCT06695871 | Not Yet Recruiting

• 2 other identifiers: 2024PHB398-001MBZX0102024007
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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

Keywords

Loop electrosurgical excision procedure; Patient navigation; Quality of life; Sexual function

Outcome Measures

Primary Outcomes (1)

• Quality of Life

  The quality of life six months post-surgery was assessed using 36-Item Short Form Survey.

  six months after LEEP

Secondary Outcomes (6)

• Sexual function index

  before LEEP, three months after LEEP, and six months after LEEP

• Anxiety

  before LEEP, three months after LEEP, and six months after LEEP

• Quality of Life

  before LEEP and three months after LEEP

• Depression

  before LEEP, three months after LEEP, and six months after LEEP

• Vaginal discharge

  three and six months after LEEP

Study Arms (2)

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.

Other: Patient navigation-based health management

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Central Study Contacts

Wenhui Ren, PhD

CONTACT

86+18800124938; rwh0617@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant research fellow

Study Record Dates

• First Submitted: November 16, 2024
• First Posted: November 19, 2024
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 31, 2025
• Last Updated: November 19, 2024

Record last verified: 2024-11

Locations

CN (1)