NCT06317714

Long-term Follow-up and Quality of Life of Patients Treated With Anticancer Drugs

Non-interventional and Longitudinal Study to Evaluate a List of Anticancer Drugs Under Real Conditions of Use and Measure the Quality of Life of Patients Treated at Rafaël Institute

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Institut Rafael · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Currently, aspects related to the effects of anticancer treatments and the quality of life of patients and their needs are still poorly documented at the Rafael Institute. Thus this study will meet a dual objective: (1) the establishment of a registry to collect data on the safety and effectiveness of innovative and expensive anticancer drugs when administered in real life and (2) a measurement quantitative quality of life of patients treated with these drugs.

Detailed description

In France, the promotion of more patient-centered medicine is among the priorities identified by the High Authority for Health in its 2024 strategic project. The patient-centered approach is based on a partnership relationship with the patient, their loved ones, and the healthcare professional or a multi-professional team to built together the best option of care. In this approach, the Rafael Institute was created with the objective of caring for people and not simply pathologies. Initiated around the problem of cancer and the harmful effects of its treatments, the Rafaël Institute offers personalisation of care and continuity of care over time by providing monitoring and support to the patient by a multi-professional and multidisciplinary team. Thus, maintaining quality of life constitutes one of the objectives of the therapeutic management of patients with cancer. Although modern oncological treatments have today enabled real advances on the biomedical level, they often have side effects that must be taken into account for the overall assessment and management of patients. Although most anticancer therapies have a negative impact on the patient's quality of life, this does not always reflect the occurrence of toxicity. Since the 1990s, quality of life has been strongly associated with survival. Patients with high overall quality of life live significantly longer than patients with low overall quality of life. The relationship between symptoms, their intensity and quality of life is essential to study to understand the perceived impact of treatments and optimize their use in daily practice. The effects of treatment and quality of life can be assessed precisely and reliably using standardized and validated self-questionnaires. Completed by patients, they make it possible to measure the qualitative aspects directly linked to their health and to take into account their subjective perception of their state of health.

Conditions

• Oncology
• Quality of Life
• Symptoms and Signs

Interventions

Type	Name	Description
OTHER	questionnaires	o Quality of life questionnaires EORTC QLQC-30 and EQ-5D-5L ° questionnaires NCI- PRO-CTCAE

Timeline

• Start date: 2024-03-08
• Primary completion: 2027-03-08
• Completion: 2027-03-08
• First posted: 2024-03-19
• Last updated: 2024-10-01

Locations

1 site across 1 country: France