- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03743961
Geriatric Intervention Contribution on Quality of Life of Elderly Patients With Metastatic Neoplasia (QUALI)
July 3, 2020 updated by: Institut de Cancérologie de la Loire
Description the Geriatric Intervention Contribution on Quality of Life of Elderly Patients With Metastatic Neoplasia : Prospective Descriptive Non-comparative Cohort ( QUALI Cohort)
The aim of this study is to describe the impact of : Geriatric intervention contribution on quality of life of elderly patients receiving systemic treatments for metastatic neoplasia
Study Overview
Status
Terminated
Intervention / Treatment
Detailed Description
Elderly cancer incidence increases exponentially with advancing age.
However, elderly patients are largely underrepresented in cancer treatment trials.
The geriatric population presents particular physical, mental, psychological or social specificities that may condition the prognosis especially for patients with metastatic neoplasia.
Recently, the measurement of quality of life (QoL) in aging population is being recognized as an important part of clinical decision.
It is therefore essential to set up prospective studies to evaluate the impact of oncogeriatric practices on the quality of life of elderly patients with metastatic neoplasia.
The main objective of this prospective study is to describe the contribution of geriatric intervention on quality of life for for elderly (> 75 years) with metastatic solid cancer receiving systemic treatment during the first 6 months of their therapeutic management.
Study Type
Observational
Enrollment (Actual)
28
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Saint-Priest-en-Jarez, France, 42270
- Institut de Cancerologie Lucien Neuwirth
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
75 years and older (Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with minimum 75 years old will perform two questionnaires about quality of life and then, according to these scores they will perform a geriatric intervention.
Description
Inclusion Criteria:
- Patient with solid metastatic neoplasia
- 75 years old or more
- Men or women
- ECOG between 0 and 3
- Patient receiving systemic antineoplasic treatment (chemotherapy, hormonotherapy, immunotherapy, targeted therapy)
Exclusion Criteria:
- ECOG 4
- Localized cancer
- Patients already included in a study witch could modify quality of life
- Patient unable to give their consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group A : control group
Evaluation of quality of life with the EORTC QoL ELD 14 (Quality Qf Life ELDerly patients with 14 Questions) and QoL EORTC Q30 (Quality Qf Life with 30 Questions) for patients with G8 score > 14/17 |
|
Group B : geriatric intervention group
Evaluation of quality of life with the EORTC QoL ELD 14 (Quality Qf Life ELDerly patients) and QoL (Quality Qf Life) EORTC Q30 for patients with G8 score ≤14/17 ( in this arm there is two groups : patient who received geriatric intervention before treatment initiation (group A) and group of patient did not received geriatric intervention before treatment initiation( group B))
|
Geriatric intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Level of quality of life
Time Frame: 6 months
|
Level of quality of life will be measured with the QoL ELD 14 (Quality Qf Life ELDerly patients with 14 Questions)
|
6 months
|
Level of quality of life
Time Frame: 6 months
|
Level of quality of life will be measured with the QoL Q30 (Quality Qf Life with 30 Questions)
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of hospitalizations
Time Frame: 6 months
|
number of hospitalizations will be reported
|
6 months
|
Duration of hospitalizations
Time Frame: 6 months
|
Duration of hospitalizations will be reported in hours
|
6 months
|
Number of toxicities ( grade 3 and 4)
Time Frame: 6 months
|
Number of toxicities (grade 3 and 4) will be reported according to the CTCAE v4.0 (Common Terminology Criteria for Adverse Events)
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Blandine De Lavigerie, MD, Institut de Cancerologie Lucien Neuwirth
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 21, 2018
Primary Completion (Actual)
July 2, 2020
Study Completion (Actual)
July 2, 2020
Study Registration Dates
First Submitted
October 8, 2018
First Submitted That Met QC Criteria
November 15, 2018
First Posted (Actual)
November 16, 2018
Study Record Updates
Last Update Posted (Actual)
July 7, 2020
Last Update Submitted That Met QC Criteria
July 3, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-0801
- 2018-A02315-50 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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