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

NCT06317714 | Recruiting

• 2 other identifiers: IR-2023/00022023-A02233-42
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Oncology; Quality of Life; Symptoms and Signs

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Change from Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Questionnaire Core 30 (QLQ-C30) Score

  every 6 months and up to 36 months

• change from baseline in quality of life measured with the EQ5D5L questionnaire

  every 6 months and up to 36 months

Interventions

questionnaires OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Institut Rafael: lead

Study Sites (1)

Institute Rafaël

Levallois-Perret, Institut Rafael, 92300, France

RECRUITING

MeSH Terms

Conditions

Neoplasms; Signs and Symptoms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Alain TOLEDANO, MD

CONTACT

+ 33 (0)1 84 00 70 07; alain.toledano@horg.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 19, 2024
• Study Start: March 8, 2024
• Primary Completion (Estimated): March 8, 2027
• Study Completion (Estimated): March 8, 2027
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)