Follow-up in Gynecological Cancer Survivors: An EORTC QLG-GCG Survivorship Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,100
- 试验地点
- 31
- 主要终点
- Health-related quality of life
研究概览
简要总结
A cross-sectional prospective study of follow-up in gynecologic cancer patients after primary treatment
详细描述
The objective of this study is to identify physical and psychosocial problems and needs after treatment for gynecological cancer.
1100 patients stratified by cancer sites and treatment - a minimum of 120 patients within each stratum - will be recruited.
Institutional data on follow-up policy, demographic and clinical data (related to treatment history and tumor characteristics) will be collected. Patients will complete a set of 76 Quality of Life questions, at one single time point.
Descriptive analyses will be conducted to characterize the collected data. Multivariate model building will be used to identify patterns of physical, psychological and social problems based on factors specific to the patient and to the disease. Logistic multinomial or continuous regression analysis will be used to investigate which socio-demographic, clinical variables, or institutional are associated significantly with compromised quality of life and sexual health outcomes. Exploratory factor analysis will be used to explore the factor structure of the various PROMs to identify issue clustering.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histological proven gynecological cancer (cervical, endometrial, ovarian (including fallopian tube and peritoneal primary), vulva).
- •FIGO stage I-IV before completion of primary therapy.
- •Disease-free without any evidence of relapse: no symptoms or signs potentially indicating recurrent disease (assessed according to standard clinical parameters using physical and gynecological examination, blood tests, CA 125 (ovarian cancer), or radiological imaging techniques).
- •At least 6 months but no more than 5 years since completion of primary treatment.
- •Performance status 0, 1 or 2 (WHO scale).
- •Age ≥ 18 years.
- •Ability to understand and fill out questionnaires.
- •Written informed consent according to ICH/GCP, and national/local regulations.
排除标准
- •Other cancer diagnosis in the past 5 years.
- •Patients participating in interventional clinical studies with Quality of Life as primary endpoint.
- •Any psychological (including pre-existing psychiatric disorders), familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
结局指标
主要结局
Health-related quality of life
时间窗: 15 months after first patient inclusion
It will be evaluated using self-administered EORTC QLQ-C30 questionnaire
次要结局
未报告次要终点