Effect of Patient Navigation-based Health Management Model on Quality of Life and Sexual Function After LEEP in Patients With Cervical Lesions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Quality of Life
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
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.
干预措施: Patient navigation-based health management (Other)
结局指标
主要结局
Quality of Life
时间窗: six months after LEEP
The quality of life six months post-surgery was assessed using 36-Item Short Form Survey.
次要结局
- 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)
- Recurrence rates(three and six months after LEEP)
研究者
Ren Wenhui
Assistant research fellow
Peking University People's Hospital