Feasibility Study of a Prospective and Pragmatic Cohort

NCT02864797 | Unknown

• 1 other identifier: P/2014/238
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecologic Cancers

Keywords

Health related quality of life; patient reported outcomes; cohort; e-health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Participation rate

  at the last inclusion, up to 12 months

• acceptability of the use of the CHES and tablets computer

  at study completion, up to 24 months

• frequency of use of the QoL results by the physicians

  at study completion, up to 24 months

• occurence and type of missing data

  at study completion, up to 24 months

• attrition

  at study completion, up to 24 months

Study Arms (1)

Health related quality of life collected via CHES

EXPERIMENTAL

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

Interventions

Health related quality of life collected via CHES OTHER

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

Health related quality of life collected via CHES

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• patient with recurrent cancer
• patient with legal incapacity or limited legal capacity
• patient without any social insurance
• patient unlikely to cooperate

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

CHU Besançon

Besançon, 25000, France

Location

Study Officials

• Rajeev RAMANAH, MD PhD

  CHU Besançon

  PRINCIPAL INVESTIGATOR

• Elsa KALBACHER, MD

  CHU Besançon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2016
• First Posted: August 12, 2016
• Study Start: September 29, 2015
• Primary Completion: August 22, 2018
• Study Completion: August 22, 2018
• Last Updated: October 13, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)