- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03230305
Elderly CAncer Patient: Qualitative and Quantitative Factors of Inclusion Failure in Clinical Trials (Quali-SAGE)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Creteil, France, 94010
- Henri Mondor Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Aged 70 years or over
- With solid cancer irrespective of the stage
- Pre-screened or screened for at least one ongoing clinical trial in the center
- Informed oral consent (patient, his/her legal representant, trustworthy person or family member)
- Social security affiliation
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Elderly cancer patient cohort
|
If a patient is invited to participate in the a clinical trial, inclusion's status (included or/not) will be sought.
If a patient is not invited to participate,an ethnographic interview will be held with his physician(s) in charge of him and the clinical trial and with clinical studies technician responsible for management.The reasons for non-invitation will be collected from an epidemiological survey multiple choices.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Invitation to participate in at least one clinical trial currently ongoing
Time Frame: one year follow up
|
one year follow up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Inclusion in at least one clinical trial currently ongoing
Time Frame: one year follow up
|
one year follow up
|
Secondary exclusion or Premature Termination or Withdrawal
Time Frame: one year follow up
|
one year follow up
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Florence Canouï-Poitrine, MD, PhD, Assistance Publique - Hôpitaux de Paris
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NI15022
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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