NCT02864797: GYNEQOL-Pilot

Feasibility Study of a Prospective and Pragmatic Cohort

Status unknown NA Last updated 13 October 2017

What this trial tests

NA trial testing Health related quality of life collected via CHES in Gynecologic Cancers in 116 participants. Status unknown.

Timeline

29 September 2015

Primary endpoint
22 August 2018

22 August 2018

Quick facts

Lead sponsor	Centre Hospitalier Universitaire de Besancon
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	116
Start date	29 September 2015
Primary completion	22 August 2018
Estimated completion	22 August 2018
Sites	1 location across France

Drugs / interventions tested

• Health related quality of life collected via CHES

Conditions studied

• Gynecologic Cancers — all drugs for Gynecologic Cancers →

Sponsor

Centre Hospitalier Universitaire de Besancon

Who can join

18 and older, female only, with Gynecologic Cancers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Health-related quality of life assessment for patients with advanced or metastatic renal cell carcinoma treated with a tyrosine kinase inhibitor using electronic patient-reported outcomes in daily clinical practice (QUANARIE trial): study protocol.
   Mouillet G, Fritzsch J, Paget-Bailly S, Pozet A, et al · · 2019 · cited 6× · PMID 30717745 · DOI 10.1186/s12955-019-1085-1