Routine Electronic Monitoring Of Quality Of Life -Poumon (REMOQOL-Poumon)
NCT ID: NCT04857970
Last Updated: 2021-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
72 participants
OBSERVATIONAL
2019-02-20
2025-08-31
Brief Summary
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The aim of this study is to investigate the impact of REMOQOL on the care relationship in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are naïve for systemic treatment. To do this, the investigators want to conduct a randomized trial at the Besançon University Hospital.
Several teams are collaborating on this project: Methodology and Quality of Life Unit in Oncology (UMQVC), pneumonology and medical oncology services of the Besançon University Hospital and psychology laboratories of Franche-Comté and Burgundy Universities.
The original aspects of this research are the particular interest in the care relationship between physicians and patients, also taking an interest in the physician's experience, the strong collaboration with researchers in psychology, the use of mixed quantitative and qualitative analysis techniques as well as the design of randomized study.
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Detailed Description
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In control arm, HRQoL questionnaires (QLQ-C30+LC13) are administered in a paper-pencil way, without transmission of results to physicians.
Patients are followed for four encounters with HRQoL collection. The primary outcome, measured with the AREP questionnaire, is assessed after those four encounters.
At the end of the follow-up, a semi-structured interview with a researcher in psychology and concerning the care relationship is proposed to a sub-cohort of patients (around ten patients in each arm).
After each encounter, physicians are asked to answer a questionnaire on viewing and use of HRQoL scores. Every physician will be interviewed on care relationship by a researcher in psychology.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Electronic HRQoL questionnaires with feedback to physicians
40 patients allocated in this arm will answer HRQOL questionnaires using an electronic form in CHES Software. The HRQoL scores, presented as graphics, will be transmitted to physicians.
Electronic HRQoL questionnaires with feedback to physicians
Use of the CHES software for HRQoL collection and graphical display of the patients' HRQoL scores to physicians
Paper-pencil HRQoL questionnaires w.o. feedback to physician
40 patients allocated in this arm will answer HRQOL questionnaires using "pencil-paper", without transmission of the HRQoL scores to physicians.
Paper-pencil HRQoL questionnaires w.o. feedback to physicians
Use of paper-pencil HRQoL questionnaires, the results of which are not presented to physicians
Interventions
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Electronic HRQoL questionnaires with feedback to physicians
Use of the CHES software for HRQoL collection and graphical display of the patients' HRQoL scores to physicians
Paper-pencil HRQoL questionnaires w.o. feedback to physicians
Use of paper-pencil HRQoL questionnaires, the results of which are not presented to physicians
Eligibility Criteria
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Inclusion Criteria
* Patients treated at University Hospital of Besançon
* No prior systemic therapy for cancer
* Males and Females, age ≥18 years old
* Patient able to complete the HRQoL questionnaires
* Patients who gave their informed consent to participate.
* Patients who realized 4 clinical encounters with collection of HRQoL
* For patients from experimental arm, the physician must have checked HRQoL results
• Any physician treating patients included in the study REMOQOL-Poumon
Exclusion Criteria
* Patients receiving oral antineoplastic therapy for whom at least monthly follow-up is not feasible
* Patients with psychopathology or serious cognitive problems
18 Years
ALL
No
Sponsors
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University of Franche-Comté
OTHER
University of Burgundy
OTHER
Centre Hospitalier Universitaire de Besancon
OTHER
Responsible Party
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Principal Investigators
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Virginie WESTEEL, MD PhD
Role: PRINCIPAL_INVESTIGATOR
CHU de Besançon
Locations
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CHU de Besançon
Besançon, , France
Countries
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Central Contacts
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Facility Contacts
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Sophie Paget-Bailly, PhD
Role: primary
Other Identifiers
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P/2018/391
Identifier Type: -
Identifier Source: org_study_id
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