Long-term Follow-up and Quality of Life of Patients Treated With Anticancer Drugs
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitut Rafael
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
< 18 years old
Patient deprived of liberty, under guardianship or unable to give consent
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
questionnaires
Other interventiono Quality of life questionnaires EORTC QLQC-30 and EQ-5D-5L ° questionnaires NCI- PRO-CTCAE
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
overall survival
OS is defined as the time from the starting date of study drug to the date of death due to any cause.
Time frame
Until death, assessed up to 36 months2
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.
Time frame
Until progression or death, assessed up to 36 months3
incidence of adverse events
graded according to NCI CTCAE v5.0
Time frame
up to 36 months4
incidence of serious adverse events
graded according to NCI CTCAE v5.0
Time frame
up to 36 monthsSecondary outcomes
1
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.
Time frame
every 6 months and up to 36 months2
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)
Time frame
every 6 months and up to 36 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov