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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

Tracking Information
First Submitted Date October 8, 2018
First Posted Date November 16, 2018
Last Update Posted Date July 7, 2020
Actual Study Start Date November 21, 2018
Actual Primary Completion Date July 2, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 15, 2018)
  • 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)
  • 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)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 15, 2018)
  • number of hospitalizations [ Time Frame: 6 months ]
    number of hospitalizations will be reported
  • Duration of hospitalizations [ Time Frame: 6 months ]
    Duration of hospitalizations will be reported in hours
  • 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)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Geriatric Intervention Contribution on Quality of Life of Elderly Patients With Metastatic Neoplasia
Official Title Description the Geriatric Intervention Contribution on Quality of Life of Elderly Patients With Metastatic Neoplasia : Prospective Descriptive Non-comparative Cohort ( QUALI Cohort)
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
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Systemic Treatment
  • Metastatic Neoplasia
  • Elderly Patients
Intervention Other: geriatric intervention
Geriatric intervention
Study Groups/Cohorts
  • 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))
    Intervention: Other: geriatric intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: July 3, 2020)
28
Original Estimated Enrollment
 (submitted: November 15, 2018)
100
Actual Study Completion Date July 2, 2020
Actual Primary Completion Date July 2, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 75 Years and older   (Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03743961
Other Study ID Numbers 2018-0801
2018-A02315-50 ( Other Identifier: ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Institut de Cancérologie de la Loire
Study Sponsor Institut de Cancérologie de la Loire
Collaborators Not Provided
Investigators
Principal Investigator: Blandine De Lavigerie, MD Institut de Cancérologie Lucien Neuwirth
PRS Account Institut de Cancérologie de la Loire
Verification Date July 2020