Clinical trial NCT02864797: Feasibility Study of a Prospective and Pragmatic Cohort
Official title: Health Related Quality of Life of Patients With Gynecologic Cancers: Feasibility Study of a Prospective and Pragmatic Cohort
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gynecologic Cancers
Keywords: Health related quality of life
patient reported outcomes
cohort
e-health
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-08-12
Enrollment: 116
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Health related quality of life (QoL)
timeFrame: month 18
Secondary outcomes:
measure: Participation rate
timeFrame: at the last inclusion, up to 12 months
measure: acceptability of the use of the CHES and tablets computer
timeFrame: at study completion, up to 24 months
measure: frequency of use of the QoL results by the physicians
timeFrame: at study completion, up to 24 months
measure: occurence and type of missing data
timeFrame: at study completion, up to 24 months
measure: attrition
timeFrame: at study completion, up to 24 months
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU Besançon
Study officials:
affiliation: CHU Besançon
name: Rajeev RAMANAH, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Besançon
name: Elsa KALBACHER, MD
role: PRINCIPAL_INVESTIGATOR
References: