OncologyTHERAPINNOVNCT06317714
Long-term Follow-up and Quality of Life of Patients Treated With Anticancer Drugs
An observational study of Oncology and Quality of Life, run by Institut Rafael at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncology, Quality of Life, Symptoms and Signs
- What is being tested?
- questionnaires
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 8 Mar 2024to 8 Mar 2027
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- < 18 years old
- Patient deprived of liberty, under guardianship or unable to give consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Institute Rafaël
Levallois-Perret, Institut Rafael, 92300
Alain Toledano, +33 (0)1 47 58 05 96
About this study
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
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.
Read the 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
- Being tested
- questionnaires
- Medical subject headings
- Neoplasms, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesOther
- Quality of life questionnaires EORTC QLQC-30 and EQ-5D-5L
° questionnaires NCI- PRO-CTCAE
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
OS is defined as the time from the starting date of study drug to the date of death due to any cause.
Measured: 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.
Measured: Until progression or death, assessed up to 36 months
incidence of adverse events
graded according to NCI CTCAE v5.0
Measured: up to 36 months
incidence of serious adverse events
graded according to NCI CTCAE v5.0
Measured: 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
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.
Measured: 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)
Measured: every 6 months and up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start8 Mar 2024
- Primary completion8 Mar 2027 (estimated)
- Study completion8 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Institut Rafael
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06317714
- Sponsor's protocol ID
- IR-2023/0002
- Other IDs
- 2023-A02233-42
- Acronym
- THERAPINNOV
- Status last verified
- Sep 2024
- First submitted
- 8 Mar 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06317714
- Acronym / sponsor ID
- THERAPINNOV / IR-2023/0002
- Conditions
- Oncology, Quality of Life, Symptoms and Signs
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Institut RafaelUniversity, hospital or other
- Study start
- 8 Mar 2024 (actual)
- Primary completion
- 8 Mar 2027 (estimated)
- Study completion
- 8 Mar 2027 (estimated)
- First posted
- 19 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- < 18 years old
- Patient deprived of liberty, under guardianship or unable to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaireso Quality of life questionnaires EORTC QLQC-30 and EQ-5D-5L ° questionnaires NCI- PRO-CTCAE | Other | – |
Primary outcome
overall survival
Time frame: Until death, assessed up to 36 months
OS is defined as the time from the starting date of study drug to the date of death due to any cause.
progression free survival
Time frame: Until progression or death, assessed up to 36 months
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.
incidence of adverse events
Time frame: up to 36 months
graded according to NCI CTCAE v5.0
incidence of serious adverse events
Time frame: up to 36 months
graded according to NCI CTCAE v5.0
2 secondary outcomes
Change from Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Questionnaire Core 30 (QLQ-C30) Score
Time frame: every 6 months and up to 36 months
change from baseline in quality of life measured with the EQ5D5L questionnaire
Time frame: every 6 months and up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oncology and Quality of Life, run by Institut Rafael at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alain TOLEDANO, MD (+ 33 (0)1 84 00 70 07, alain.toledano@horg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: Until death, assessed up to 36 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.