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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • France
      • Saint-Priest-en-Jarez, France, 42270
        • Institut de Cancérologie 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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))
Other: geriatric intervention
Geriatric intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut de Cancérologie de la Loire

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Blandine De Lavigerie, MD, Institut de Cancérologie 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 21, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 2, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 2, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 8, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 16, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 7, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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