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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Oncology; Symptoms and Signs
• Intervention / Treatment: Other: questionnaires

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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Alain TOLEDANO, MD; Phone Number: + 33 (0)1 84 00 70 07; Email: alain.toledano@horg.fr

Study Locations

• France
  • Institut Rafael
    • Levallois Perret, Institut Rafael, France, 92300
      • Recruiting
      • Institute Rafaël
      • Contact: Alain Toledano; Phone Number: +33 (0)1 47 58 05 96

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival	OS is defined as the time from the starting date of study drug to the date of death due to any cause.	Until death, assessed up to 36 months
progression free survival	PFS is defined as the time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first.	Until progression or death, assessed up to 36 months
incidence of adverse events	graded according to NCI CTCAE v5.0	up to 36 months
incidence of serious adverse events	graded according to NCI CTCAE v5.0	up to 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Questionnaire Core 30 (QLQ-C30) Score	The EORTC QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Individual responses for each of 28 items are given on a 4-point scale (1=Not at All to 4=Very Much), with a lower score indicating a better outcome, and responses for each of 2 items (overall health and overall quality of life) are given on a 7-point scale (1=Very poor to 7=Excellent), with a higher score indicating a better outcome.	every 6 months and up to 36 months
change from baseline in quality of life measured with the EQ5D5L questionnaire	The questionnaire covers five dimensions of health: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. The levels of severity for each dimension ranges from no problems (1) to extreme problems/unable to perform. The raw scores are also converted to an EQ-5D index value using a scoring algorithm (British tariff) ranging from -0.594 (worst perceived health state) to 1.00 (best perceived health state)	every 6 months and up to 36 months

Collaborators and Investigators

• Sponsor: Institut Rafael

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2024
• Primary Completion (Estimated): March 8, 2027
• Study Completion (Estimated): March 8, 2027

Study Registration Dates

• First Submitted: March 8, 2024
• First Submitted That Met QC Criteria: March 14, 2024
• First Posted (Actual): March 19, 2024

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 30, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IR-2023/0002; 2023-A02233-42 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No