Study Stopped
Low rythm of inclusions
Geriatric Intervention Contribution on Quality of Life of Elderly Patients With Metastatic Neoplasia
QUALI
Description the Geriatric Intervention Contribution on Quality of Life of Elderly Patients With Metastatic Neoplasia : Prospective Descriptive Non-comparative Cohort ( QUALI Cohort)
2 other identifiers
observational
28
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2018
CompletedFirst Posted
Study publicly available on registry
November 16, 2018
CompletedStudy Start
First participant enrolled
November 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 2, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 2, 2020
CompletedJuly 7, 2020
July 1, 2020
1.6 years
October 8, 2018
July 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Level of quality of life
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
Level of quality of life will be measured with the QoL Q30 (Quality Qf Life with 30 Questions)
6 months
Secondary Outcomes (3)
number of hospitalizations
6 months
Duration of hospitalizations
6 months
Number of toxicities ( grade 3 and 4)
6 months
Study Arms (2)
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))
Interventions
Eligibility Criteria
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.
You may qualify if:
- Patient with solid metastatic neoplasia
- years old or more
- Men or women
- ECOG between 0 and 3
- Patient receiving systemic antineoplasic treatment (chemotherapy, hormonotherapy, immunotherapy, targeted therapy)
You may not qualify if:
- ECOG 4
- Localized cancer
- Patients already included in a study witch could modify quality of life
- Patient unable to give their consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, 42270, France
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Blandine De Lavigerie, MD
Institut de Cancérologie Lucien Neuwirth
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2018
First Posted
November 16, 2018
Study Start
November 21, 2018
Primary Completion
July 2, 2020
Study Completion
July 2, 2020
Last Updated
July 7, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share