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Geriatric Intervention Contribution on Quality of Life of Elderly Patients With Metastatic Neoplasia (QUALI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03743961
Recruitment Status : Terminated (Low rythm of inclusions)
First Posted : November 16, 2018
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Institut de Cancérologie de la Loire

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

Condition or disease Intervention/treatment
Systemic Treatment Metastatic Neoplasia Elderly Patients Other: geriatric intervention

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.

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Study Type : Observational
Actual Enrollment : 28 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Description the Geriatric Intervention Contribution on Quality of Life of Elderly Patients With Metastatic Neoplasia : Prospective Descriptive Non-comparative Cohort ( QUALI Cohort)
Actual Study Start Date : November 21, 2018
Actual Primary Completion Date : July 2, 2020
Actual Study Completion Date : July 2, 2020

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))
Other: geriatric intervention
Geriatric intervention




Primary Outcome Measures :
  1. 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)

  2. 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)


Secondary Outcome Measures :
  1. number of hospitalizations [ Time Frame: 6 months ]
    number of hospitalizations will be reported

  2. Duration of hospitalizations [ Time Frame: 6 months ]
    Duration of hospitalizations will be reported in hours

  3. 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)



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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes 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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03743961


Locations
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France
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, France, 42270
Sponsors and Collaborators
Institut de Cancérologie de la Loire
Investigators
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Principal Investigator: Blandine De Lavigerie, MD Institut de Cancérologie Lucien Neuwirth
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Responsible Party: Institut de Cancérologie de la Loire
ClinicalTrials.gov Identifier: NCT03743961    
Other Study ID Numbers: 2018-0801
2018-A02315-50 ( Other Identifier: ANSM )
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut de Cancérologie de la Loire:
quality of life
elderly
metastatic neoplasia
systemic therapies
Additional relevant MeSH terms:
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Neoplasms