Gynecologic Cancers Clinical Trial
— GYNEQOL-PilotOfficial title:
Health Related Quality of Life of Patients With Gynecologic Cancers: Feasibility Study of a Prospective and Pragmatic Cohort
Verified date | October 2017 |
Source | Centre Hospitalier Universitaire de Besancon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 116 |
Est. completion date | August 22, 2018 |
Est. primary completion date | August 22, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - patient with recurrent cancer - patient with legal incapacity or limited legal capacity - patient without any social insurance - patient unlikely to cooperate |
Country | Name | City | State |
---|---|---|---|
France | CHU Besançon | Besançon |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Besancon |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Health related quality of life (QoL) | 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 | month 18 | |
Secondary | Participation rate | the rate of number of included patients on number of eligible patients | at the last inclusion, up to 12 months | |
Secondary | acceptability of the use of the CHES and tablets computer | How did patients perceived the use of tablets computer and CHES software, qualitative assessment by the clinical research associates | at study completion, up to 24 months | |
Secondary | frequency of use of the QoL results by the physicians | how many times physicians used the CHES in their clinical practice. | at study completion, up to 24 months | |
Secondary | occurence and type of missing data | count of QoL missing data at each time point | at study completion, up to 24 months | |
Secondary | attrition | count of patients lost of follow up at study completion | at study completion, up to 24 months |
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