Health Related Quality of Life of Patients With Gynecologic Cancers: Feasibility Study of a Prospective and Pragmatic Cohort
试验速览
- 阶段
- 不适用
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- Health related quality of life (QoL)
研究概览
简要总结
Gynecologic cancers (cancers of cervix, endometrium, ovary, vagina, and vulva) represent an important part of the female cancer in France with more than 15 000 new cases in 2012. As considerable progress have been made in diagnostic and therapeutic strategies, an important part of the gynecologic cancers are diagnosed at an early stage and globally, the after treatment overall survival rate is estimated to more than 80% at five years. Thus, it is of evident interest to study health related Quality of Life (QoL) among these patients who will continue to live after their cancer and to consider QoL as a primary end-point, beyond overall survival.
The GYNEQOL (health related Quality Of Life of women with GYNEcologic cancer) group is a working group initiated in Besançon and whose goal is to investigate QoL of gynecologic cancers' patients. It gathers several entities from the hospital of Besançon, namely the Methodology and Quality of Life in Oncology Unit, the Gynecologic Unit and the Oncology Unit. The GYNEQOL study is a project of a prospective cohort study, in a pragmatic clinical practice, with the main objective of longitudinally collecting and analyzing QoL data of these women.
The pilot phase, GYNEQOL-Pilot, restricted to the hospital of Besançon, has started in September 2015 with the goal of assessing the feasibility of the cohort. The feature of this study is that patients answer to QoL questionnaires using tablets computer and the Computer-based Health Evaluation System software (CHES). Indeed, use of electronic solutions to collect patient reported outcomes is drastically increasing those last years. It has been underlined that routinely collecting symptoms could increase both QoL and survival among cancer patients. It enables to use these data in real-time in routine practice by presenting QoL scores to physicians in simple graphical histograms for both transversal and longitudinal measurements and it ensures a reliable data collection.
详细描述
Gynecologic cancers (cancers of cervix, endometrium, ovary, vagina, and vulva) represent an important part of the female cancer in France with more than 15 000 new cases in 2012. As considerable progress have been made in diagnostic and therapeutic strategies, an important part of the gynecologic cancers are diagnosed at an early stage and globally, the after treatment overall survival rate is estimated to more than 80% at five years. Thus, it is of evident interest to study health related Quality of Life (QoL) among these patients who will continue to live after their cancer and to consider QoL as a primary end-point, beyond overall survival.
The GYNEQOL (health related Quality Of Life of women with GYNEcologic cancer) group is a working group initiated in Besançon and whose goal is to investigate QoL of gynecologic cancers' patients. It gathers several entities from the hospital of Besançon, namely the Methodology and Quality of Life in Oncology Unit, the Gynecologic Unit and the Oncology Unit. The GYNEQOL study is a project of a prospective cohort study, in a pragmatic clinical practice, with the main objective of longitudinally collecting and analyzing QoL data of these women.
The pilot phase, GYNEQOL-Pilot, restricted to the hospital of Besançon, has started in September 2015 with the goal of assessing the feasibility of the cohort. The feature of this study is that patients answer to QoL questionnaires using tablets computer and the Computer-based Health Evaluation System software (CHES). Indeed, use of electronic solutions to collect patient reported outcomes is drastically increasing those last years. It has been underlined that routinely collecting symptoms could increase both QoL and survival among cancer patients. It enables to use these data in real-time in routine practice by presenting QoL scores to physicians in simple graphical histograms for both transversal and longitudinal measurements and it ensures a reliable data collection.
Objectives The main objective is to collect and analyse QoL of gynecologic cancer patients in a prospective and pragmatic cohort study.
The primary endpoint will be QoL assessed by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 (Core Quality of Life Questionnaire), for the following targeted dimensions : global health, emotional, social and functional roles and fatigue
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •patient with newly diagnosed gynecologic cancer (ovaries, endometrium, cervix, vagina, vulva, fallopian tube), whatever the stage and histological type.
- •patient treated at Besançon University Hospital
- •patient aged of 18 years old or older
- •patient who do understand French
- •patient without any major cognitive impairment
- •patient who hav signed the informed consent
- •patient affiliated to the French social insurance
排除标准
- •patient with recurrent cancer
- •patient with legal incapacity or limited legal capacity
- •patient without any social insurance
- •patient unlikely to cooperate
研究组 & 干预措施
Health related quality of life collected via CHES
Health related quality of life (QoL) is collected at each follow-up visit using tablets computer and CHES software.
干预措施: Health related quality of life collected via CHES (Other)
结局指标
主要结局
Health related quality of life (QoL)
时间窗: month 18
The primary endpoint will be QoL assessed by the EORTC QLQ-C30, for the following targeted dimensions : global health, emotional, social and functional roles and fatigue
次要结局
- Participation rate(at the last inclusion, up to 12 months)
- acceptability of the use of the CHES and tablets computer(at study completion, up to 24 months)
- frequency of use of the QoL results by the physicians(at study completion, up to 24 months)
- occurence and type of missing data(at study completion, up to 24 months)
- attrition(at study completion, up to 24 months)