Feasibility Study of a Prospective and Pragmatic Cohort

Study Overview
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Brief Summary
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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
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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).

Official Title
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Health Related Quality of Life of Patients With Gynecologic Cancers: Feasibility Study of a Prospective and Pragmatic Cohort

Conditions
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Gynecologic Cancers

Intervention / Treatment
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* Other: Health related quality of life collected via CHES


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Health related quality of life collected via CHES<br>Health related quality of life (QoL) is collected at each follow-up visit using tablets computer and CHES software. | Other: Health related quality of life collected via CHES<br>* Health related quality of life (QoL) is collected at each follow-up visit using tablets computer and CHES software. Thus, QoL's results are directly presented to clinicians via the CHES, in order to be considered as part of the supportive care strategy at the end of the study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participation rate | the rate of number of included patients on number of eligible patients | at the last inclusion, up to 12 months | 
| 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 | 
| 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 | 
| occurence and type of missing data | count of QoL missing data at each time point | at study completion, up to 24 months | 
| attrition | count of patients lost of follow up at study completion | at study completion, up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Health related quality of life, patient reported outcomes, cohort, e-health