Informations générales (source: ClinicalTrials.gov)

NCT04857970 En recrutement
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
Observational
  • Carcinome pulmonaire non à petites cellules
  • Tumeurs du poumon
Centre Hospitalier Universitaire de Besancon (Voir sur ClinicalTrials)
février 2019
août 2025
29 juin 2024
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.
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Etablissements

Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CHU de Besançon - Besançon - France Sophie Paget-Bailly, PhD En recrutement Contact (sur clinicalTrials)

Critères

Tous
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