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

Официальное название

Effect of Patient Navigation-based Health Management Model on Quality of Life and Sexual Function After LEEP in Patients With Cervical Lesions

Обзор

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Quality of Life [Срок оценки: six months after LEEP]

Вторичные конечные точки (6)

• Sexual function index [Срок оценки: before LEEP, three months after LEEP, and six months after LEEP]
• Anxiety [Срок оценки: before LEEP, three months after LEEP, and six months after LEEP]
• Quality of Life [Срок оценки: before LEEP and three months after LEEP]
• Depression [Срок оценки: before LEEP, three months after LEEP, and six months after LEEP]
• Vaginal discharge [Срок оценки: three and six months after LEEP]
• Recurrence rates [Срок оценки: three and six months after LEEP]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

Китай · 1 центр

• Peking University People's Hospital — Пекин

Идентификаторы

NCT: NCT06695871 · 2024PHB398-001 · MBZX0102024007

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗