Gynecologic Cancers Clinical Trial
Official title:
Health Related Quality of Life of Patients With Gynecologic Cancers: Feasibility Study of a Prospective and Pragmatic Cohort
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.
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
The secondary objectives are to assess those endpoints :
- the participation rate
- the acceptability of the use of the CHES and tablets computer
- use of the QoL results by the physicians
- occurence and type of missing data
- attrition
Study population All adult patients with gynecologic cancers (ovarian, endometrial and
cervical cancers), treated in the University hospital of Besançon, and who gave their
informed consent, are prospectively included. Patients who do not well understand French, who
have cognitive impairment or who do not have social insurance are not included.
Data collection Socio-demographic, socio-economic (occupational group, attained education,
income), behavioural (physical activity), previous history and familial history of cancer,
clinical, medical data, biomarkers, therapeutic strategies, toxicities and QoL will be
prospectively collected at inclusion and throughout the follow-up. As we are in the context
of pragmatic clinical practice, visits are based on the usual follow-up of gynecologic cancer
patients.
QoL will be assessed using EORCT QLQ-C30 questionnaire and the specific modules QLQ-CX24
(cervix), QLQ-OV28 (ovaries) and QLQ-EN24 (endometrium), using a time-driven design. These
auto-questionnaires will be administrated with the CHES and the help of an clinical research
associate at inclusion, before treatment, 3 weeks after treatment and at each "routine"
follow-up visit during at least 6 months. If patients do not want to use tablet computer,
"pen-paper questionnaire" will be administered.
Statistical analyses Usual statistical methods will be used for description of
socio-demographic, socio-professional, clinical of patients at inclusion and of QoL
throughout the follow-up. Those characteristics will be described considering cancer
localizations and stages and used therapeutics/surgeries. We will also described the
participation rate.
The acceptability of the use of the CHES and tablets computer and the use of the QoL results
by the physicians will be qualitatively described.
Missing data will be described by assessing profile of patients with missing data, occurence
of missing data for each QoL item, incomplete QoL questionnaire rate and type of missing data
(missing at random, missing completely at random, missing not at random).
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