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

Lung Cancer Clinical Trial

Official title:

Impact of Routine Electronic Monitoring of Health-related Quality of Life on Care Relationship of Cancer Patients With Non-small Cell Lung Cancer, Locally Advanced or Metastatic, Systemic Treatment-naïve: a Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04857970
• Other study ID #: P/2018/391
• Status: Recruiting
• Start date: February 20, 2019
• Est. completion date: August 2025

Study information

• Verified date: April 2021
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Sophie PAGET BAILLY, PhD
• Phone: 0033370632176
• Email: spaget[@]chu-besancon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: August 2025
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria for patients:

• Any patient diagnosed with locally advanced or metastatic non-small cell lung cancer
• 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. Inclusion Criteria for the sub cohort of patients undergoing the semi-structured interview

with the researcher in psychology:

• Patients who realized 4 clinical encounters with collection of HRQoL
• For patients from experimental arm, the physician must have checked HRQoL results

Inclusion Criteria for physicians:

• Any physician treating patients included in the study REMOQOL-Poumon

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Other:
• 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

Locations

Country	Name	City	State
France	CHU de Besançon	Besançon

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon	University of Burgundy, University of Franche-Comté

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quality of care relationship, assessed for patients and physicians: AREP questionnaire	care relationship assessed with the AREP questionnaire. AREP is for "adjustment relationnel expérimenté perçu", which means experienced and perceived relational adjustment.	Month 3
Secondary	Quality of care relationship, assessed for patients and physicians: semi-structured interviews	care relationship assessed with semi-structured interviews conducted by a researcher in psychology.	Month 24
Secondary	Descriptive characteristics: socio-demographic, clinic, treatments and HRQoL scores	Classical characteristics such as age at diagnosis, disease stage, type of treatments, HRQoL scores	Month 3
Secondary	Preferences and expectations in the care relationship, assessed for patients and physicians	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 )	Day 1
Secondary	Acceptability of HRQoL collection	assessment of HRQoL collection considering usefulness, ease and user-friendliness	Month 24
Secondary	intention of use of REMOQOL		Month 24
Secondary	Overall survival	Time from randomization to death from any cause, assessed at end of inclusion + 2 years	Year 5
Secondary	Progression-free survival	Time from randomization to disease progression or death from any cause	Year 5