Clinical trial NCT04857970: Routine Electronic Monitoring Of Quality Of Life -Poumon (REMOQOL-Poumon)
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Non Small Cell Lung Cancer
Keywords: Cancer
Health-related quality of life
E-health
Patient-reported outcome
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
Collaborators: name: University of Franche-Comté
name: University of Burgundy
First posted: 2021-04-23
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: quality of care relationship, assessed for patients and physicians: AREP questionnaire
timeFrame: Month 3
Secondary outcomes:
measure: Quality of care relationship, assessed for patients and physicians: semi-structured interviews
timeFrame: Month 24
measure: Descriptive characteristics: socio-demographic, clinic, treatments and HRQoL scores
timeFrame: Month 3
measure: Preferences and expectations in the care relationship, assessed for patients and physicians
timeFrame: Day 1
measure: Acceptability of HRQoL collection
timeFrame: Month 24
measure: intention of use of REMOQOL
timeFrame: Month 24
measure: Overall survival
timeFrame: Year 5
measure: Progression-free survival
timeFrame: Year 5
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
Study officials:
affiliation: CHU de Besançon
name: Virginie WESTEEL, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: