Ignite Creation Date:
2024-05-06 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 2:13 PM
Study NCT ID:
NCT05049044
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-10-19
First Post:
2020-11-13
Brief Title:
Observational Prospective Study of Quality of Life in Unresectable TNM Stage III NSCLC OBSTINATE
Sponsor:
Groupe Francais De Pneumo-Cancerologie
Organization:
Groupe Francais De Pneumo-Cancerologie
Study Overview
Official Title:
Observational Prospective Study of Quality of Life in Unresectable TNM Stage III NSCLC OBSTINATE
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OBSTINATE
Brief Summary:
OBSTINATE is an observational national prospective multicentric study on Quality of life in patients with unresecable stade III non-small cell lung cancers
Locally advanced non-small cell lung cancers NSCLCs with a Tumor Node and Metastasis TNM stage III patients represent approximately a third of newly discovered NSCLCs every year and a very heterogeneous group of clinical situations Therapies are multidisciplinary and very heterogeneous across oncology centers Patients with locally advanced NSCLC have a high symptom burden that is known to affect their quality of life Health-related quality of life HR-QoL is a specific and multidimensional type of patient-reported outcome PRO related to the physical psychological and social impact of the disease and its treatment as perceived by patients HR-QoL allows together with data of efficacy and safety a more complete assessment of risks and benefits of each treatment Therefore QoL maintenance is a valuable consideration for treatment decisions especially in the rapidly evolving therapeutic landscape of unresectable NSCLC
The study is designed to collect PROs HR-QoL data from every new patient diagnosed with an unresectable stage III NSCLC over a period of 18 months We also aim to describe clinical characteristics of these patients the therapeutic strategies conducted and outcomes in a real-word oncological practice
Locally advanced non-small cell lung cancers NSCLCs with a Tumor Node and Metastasis TNM stage III patients represent approximately a third of newly discovered NSCLCs every year and a very heterogeneous group of clinical situations Therapies are multidisciplinary and very heterogeneous across oncology centers Patients with locally advanced NSCLC have a high symptom burden that is known to affect their quality of life Health-related quality of life HR-QoL is a specific and multidimensional type of patient-reported outcome PRO related to the physical psychological and social impact of the disease and its treatment as perceived by patients HR-QoL allows together with data of efficacy and safety a more complete assessment of risks and benefits of each treatment Therefore QoL maintenance is a valuable consideration for treatment decisions especially in the rapidly evolving therapeutic landscape of unresectable NSCLC
The study is designed to collect PROs HR-QoL data from every new patient diagnosed with an unresectable stage III NSCLC over a period of 18 months We also aim to describe clinical characteristics of these patients the therapeutic strategies conducted and outcomes in a real-word oncological practice
Detailed Description:
OBSTINATE is an observational prospective national multicentric study conducted in patients newly diagnosed with an unresectable stage III NSCLC with exclusion of early stages NSCLC classified to pathological stage III
OBSTINATE is a study planned to include 450 patients between 50 to 70 GFPC-affiliates or GFPC-associated centers approximately All centers are located in France The participating Site Investigators will be treating physicians within one of the participating centers
After screening for eligibility checks patients will receive the Patient Information Note from the Site Investigators This Patient information Note will describe the study purpose and modalities Patients who meet the eligibility criteria and do not oppose to data collection will be enrolled The schedule of the medical visits in the study center will depend on the patient and hisher routine clinical care Protocol-relevant data will be collected by the treating physician within each center for up to 5 years following the last patients enrollment in the study
Patients included in the study will complete the self-assess questionnaires at enrollment and during routine care follow-up according to pre-specified data collection schedule
Usual practices or modalities of follow-up of patients will remain unchanged compared to the current clinical practice as the study is designed to provide descriptive summary information
OBSTINATE is a study planned to include 450 patients between 50 to 70 GFPC-affiliates or GFPC-associated centers approximately All centers are located in France The participating Site Investigators will be treating physicians within one of the participating centers
After screening for eligibility checks patients will receive the Patient Information Note from the Site Investigators This Patient information Note will describe the study purpose and modalities Patients who meet the eligibility criteria and do not oppose to data collection will be enrolled The schedule of the medical visits in the study center will depend on the patient and hisher routine clinical care Protocol-relevant data will be collected by the treating physician within each center for up to 5 years following the last patients enrollment in the study
Patients included in the study will complete the self-assess questionnaires at enrollment and during routine care follow-up according to pre-specified data collection schedule
Usual practices or modalities of follow-up of patients will remain unchanged compared to the current clinical practice as the study is designed to provide descriptive summary information
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None