Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT03230305
Status:
COMPLETED
Last Update Posted:
2020-11-23
First Post:
2017-07-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Elderly CAncer Patient: Qualitative and Quantitative Factors of Inclusion Failure in Clinical Trials
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Elderly CAncer Patient: Qualitative and Quantitative Factors of Inclusion Failure in Clinical Trials
Status:
COMPLETED
Status Verified Date:
2020-11
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:
Quali-SAGE
Brief Summary:
The transposition of the results of biomedical research to medical management of patients in real-life setting depends highly from patient's selection. In Europe and the United States, the majority of cancers occur after 65 years. In France, 45% of cancers diagnosed in 2012 were after 70 years or 158,722 in absolute value. In this context, the median age at diagnosis was 72 years old. Disease particularly affecting the elderly, cancer is also characterized by the importance of biomedical research devoted to it. Despite the dynamism of the research activity in oncology and therefore the number of affected patients, the elderly are paradoxically sparsely included in clinical trials. Numerous studies have focused in recent years, to identify possible causes of under-representation of elderly patients in clinical trials but most of them focused on eligibility criteria and few on barriers related to non-invitation or non-inclusion in eligible patients.
The investigator postulate that a qualitative survey based on an structured epidemiological device will able to objective evidences of reasons related to the patient, participant familial caregivers, participant physician and the clinical center organization for participating or not to a clinical trial and the interrelations between the identified reasons.
The main objective is to assess reasons of non-participation of older patients with cancer in clinical trials, from the physicians, patients and family caregivers' perspectives using qualitative and quantitative methods.
The secondary objectives are:
To investigate the social representation and construction of being "aged" from the patient, physician and family caregiver perspective (qualitative part).
To compare the reasons of non-participation regarding age class (old and very old), localized versus metastatic disease and tumor site (quantitative part).
To characterize the profiles of participants and non-participants to clinical trial among older patients with cancer thanks to qualitative and quantitative data.
Method Quali SAGE is a French, socio-epidemiologic, multicenter prospective study that includes patients aged 70 years or over, with solid tumor (irrespective of the stage) in French hospitals.
The investigator postulate that a qualitative survey based on an structured epidemiological device will able to objective evidences of reasons related to the patient, participant familial caregivers, participant physician and the clinical center organization for participating or not to a clinical trial and the interrelations between the identified reasons.
The main objective is to assess reasons of non-participation of older patients with cancer in clinical trials, from the physicians, patients and family caregivers' perspectives using qualitative and quantitative methods.
The secondary objectives are:
To investigate the social representation and construction of being "aged" from the patient, physician and family caregiver perspective (qualitative part).
To compare the reasons of non-participation regarding age class (old and very old), localized versus metastatic disease and tumor site (quantitative part).
To characterize the profiles of participants and non-participants to clinical trial among older patients with cancer thanks to qualitative and quantitative data.
Method Quali SAGE is a French, socio-epidemiologic, multicenter prospective study that includes patients aged 70 years or over, with solid tumor (irrespective of the stage) in French hospitals.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: