Routine Electronic Monitoring Of Quality Of Life -Poumon (REMOQOL-Poumon)

Recruiting

• Conditions: Lung Cancer; Non Small Cell Lung Cancer
• Interventions: Other: Electronic HRQoL questionnaires with feedback to physicians; Other: Paper-pencil HRQoL questionnaires w.o. feedback to physicians

• Registration Number: NCT04857970
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief Summary

Routine electronic monitoring of health-related quality of life (REMOQOL) consists of collecting HRQoL patients' data via an electronic device in order to provide these data to healthcare providers. Collected data could be used by professionals to personalize care through for instance, orientation towards personalized supportive care; assessment of toxicities related to treatments or adapted treatments.

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.

Detailed Description

REMOQOL-Poumon is an interventional, prospective, randomized study, conducted in Besançon University Hospital. Patients are randomized whether in the experimental arm or in the control arm. Intervention in experimental arm consists of administration of HRQoL questionnaires (QLQ-C30 \& QLQ-LC13) using the CHES software (Computer-based Health Evaluation System) and presentation of the HRQoL scores to physicians via colored graphics.

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.

Study Timeline

• Study Start: 2019-02-20
• Study First Submitted: 2020-01-10
• Status Verified: 2021-04
• Study First Submitted QC: 2021-04-22
• Last Update Submitted: 2021-04-22
• Study First Posted: 2021-04-23
• Last Update Posted: 2021-04-23
• Primary Completion: 2021-11
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Not provided

Exclusion Criteria

• Patients with tumor recurrence
• Patients receiving oral antineoplastic therapy for whom at least monthly follow-up is not feasible
• Patients with psychopathology or serious cognitive problems

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Electronic HRQoL questionnaires with feedback to physicians	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.
Paper-pencil HRQoL questionnaires w.o. feedback to physician	Paper-pencil HRQoL questionnaires w.o. feedback to physicians	40 patients allocated in this arm will answer HRQOL questionnaires using "pencil-paper", without transmission of the HRQoL scores to physicians.

Primary Outcome Measures

Name	Time	Method
quality of care relationship, assessed for patients and physicians: AREP questionnaire	Month 3	care relationship assessed with the AREP questionnaire. AREP is for "adjustment relationnel expérimenté perçu", which means experienced and perceived relational adjustment.

Secondary Outcome Measures

Name	Time	Method
Descriptive characteristics: socio-demographic, clinic, treatments and HRQoL scores	Month 3	Classical characteristics such as age at diagnosis, disease stage, type of treatments, HRQoL scores
Quality of care relationship, assessed for patients and physicians: semi-structured interviews	Month 24	care relationship assessed with semi-structured interviews conducted by a researcher in psychology.
Acceptability of HRQoL collection	Month 24	assessment of HRQoL collection considering usefulness, ease and user-friendliness
Progression-free survival	Year 5	Time from randomization to disease progression or death from any cause
Overall survival	Year 5	Time from randomization to death from any cause, assessed at end of inclusion + 2 years
Preferences and expectations in the care relationship, assessed for patients and physicians	Day 1	preferences and expectations in the care relationship assessed with the Inventory of Expectations towards the care relationship (IARSS, for Inventaire d'Attentes envers la Relation Soignant-Soigné )
intention of use of REMOQOL	Month 24

Trial Locations

Locations (1)

CHU de Besançon; 🇫🇷 Besançon, France