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

NCT04857970 | Unknown

• 1 other identifier: P/2018/391
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Non Small Cell Lung Cancer

Keywords

Cancer; Health-related quality of life; E-health; Patient-reported outcome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Quality of care relationship, assessed for patients and physicians: semi-structured interviews

  Month 24

• Descriptive characteristics: socio-demographic, clinic, treatments and HRQoL scores

  Month 3

• Preferences and expectations in the care relationship, assessed for patients and physicians

  Day 1

• Acceptability of HRQoL collection

  Month 24

• intention of use of REMOQOL

  Month 24

Study Arms (2)

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.

Other: Electronic HRQoL questionnaires with feedback 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.

Other: Paper-pencil HRQoL questionnaires w.o. feedback to physicians

Interventions

Electronic HRQoL questionnaires with feedback to physicians OTHER

Use of the CHES software for HRQoL collection and graphical display of the patients' HRQoL scores to physicians

Electronic HRQoL questionnaires with feedback to physicians

Paper-pencil HRQoL questionnaires w.o. feedback to physicians OTHER

Use of paper-pencil HRQoL questionnaires, the results of which are not presented to physicians

Paper-pencil HRQoL questionnaires w.o. feedback to physician

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with locally advanced or metastatic non-small cell lung cancer + Physicians treating patients included in the study REMOQOL-Poumon

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead
• University of Franche-Comté: collaborator
• University of Burgundy: collaborator

Study Sites (1)

CHU de Besançon

Besançon, France

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Virginie WESTEEL, MD PhD

  CHU de Besançon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophie PAGET BAILLY, PhD

CONTACT

0033370632176; spaget@chu-besancon.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2020
• First Posted: April 23, 2021
• Study Start: February 20, 2019
• Primary Completion: November 1, 2021
• Study Completion: August 1, 2025
• Last Updated: April 23, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)