Clinical trial NCT06317714: Long-term Follow-up and Quality of Life of Patients Treated With Anticancer Drugs
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Oncology
Quality of Life
Symptoms and Signs
Lead sponsor: Institut Rafael
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated at the Rafael Institute for whom treatment with an anticancer drug (innovative/expensive molecule from the list annexed to the protocol) has been indicated.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Age equal to or greater than 18 years (adult)
* Patients treated with an anticancer drug included in the list of innovative/expensive therapies (protocol appendix)
* Patients benefiting from non-pharmacological treatment at the Rafael Institute
* Who understands the French language

Exclusion Criteria:

* \< 18 years old
* Patient deprived of liberty, under guardianship or unable to give consent

Primary outcomes:
measure: overall survival
timeFrame: Until death, assessed up to 36 months
measure: progression free survival
timeFrame: Until progression or death, assessed up to 36 months
measure: incidence of adverse events
timeFrame: up to 36 months
measure: incidence of serious adverse events
timeFrame: up to 36 months
Secondary outcomes:
measure: Change from Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Questionnaire Core 30 (QLQ-C30) Score
timeFrame: every 6 months and up to 36 months
measure: change from baseline in quality of life measured with the EQ5D5L questionnaire
timeFrame: every 6 months and up to 36 months
Other outcomes:
Locations:
city: Levallois Perret
country: France
facility: Institute Rafaël
state: Institut Rafael
Study officials:
References: