MoCA vs. MMS: Which Tool to Detect Cognitive Disorders in Oncogeriatric? (MOCA-2)
Primary Purpose
Neoplasms
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Passation of neuropsychological test
Sponsored by
About this trial
This is an interventional other trial for Neoplasms focused on measuring oncogeriatric, MMS, MoCA
Eligibility Criteria
Inclusion Criteria:
- Patient aged over 70 years
- Patient with cancer (solid tumor or haemopathy) for whom a first line treatment is envisaged (whatever it is). Surgery and radiotherapy are allowed before entry into the study.
- Patient candidate for oncogeriatric assessment
- Patient agree to participate in the study
- Using the French language
Exclusion Criteria:
- Primary central nervous system or cerebral metastasis
- Evolutionary psychiatric pathology known (e.g. schizophrenia)
- Severe Visual and / or Auditory Impairment
- Patients unable to respond to cognitive tests
- Patient (s) deprived of liberty, under guardianship or curatorship
- Refusal of participation
Sites / Locations
- Centre François Baclesse
- CHU
- CH
- Ch Compiegne
- Centre Henri Becquerel
- Centre Hospitalier
Outcomes
Primary Outcome Measures
Evaluate the sensitivity of MoCA test
MoCA is considered clinically relevant if its sensitivity to identify patients with cognitive impairment is at least 75%
Secondary Outcome Measures
Full Information
NCT ID
NCT03299855
First Posted
September 26, 2017
Last Updated
October 17, 2023
Sponsor
Centre Francois Baclesse
Collaborators
UCOG (Unite de coordination en Onco-Gériatrie)
1. Study Identification
Unique Protocol Identification Number
NCT03299855
Brief Title
MoCA vs. MMS: Which Tool to Detect Cognitive Disorders in Oncogeriatric?
Acronym
MOCA-2
Official Title
MoCA vs. MMS: Which Tool to Detect Cognitive Disorders in Oncogeriatric?
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 13, 2017 (Actual)
Primary Completion Date
October 13, 2023 (Actual)
Study Completion Date
October 13, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Francois Baclesse
Collaborators
UCOG (Unite de coordination en Onco-Gériatrie)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study concerns elderly patients with cancer with onco-geriatric assessment.
This study propose to associate the collection of the results with the Mini-Cog and the CODEX with the passing of the MoCA and the MMS tests, as well as a neuropsychological assessment, in order to determine if the patients have cognitive impairments, to evaluate the sensitivity of these 4 screening tests in elderly patients seeking treatment for their cancer. The results of this study will make it possible, where appropriate, to adapt the practice in the context of oncogeriatric assessment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms
Keywords
oncogeriatric, MMS, MoCA
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Passation of MMS and MoCA tests associated to passation of neuropsychological test
Masking
Participant
Allocation
N/A
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Passation of neuropsychological test
Intervention Description
Passation of MoCA and MMS tests associated with neuropsychological test
Primary Outcome Measure Information:
Title
Evaluate the sensitivity of MoCA test
Description
MoCA is considered clinically relevant if its sensitivity to identify patients with cognitive impairment is at least 75%
Time Frame
Up 2 months after inclusion, before initiation of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient aged over 70 years
Patient with cancer (solid tumor or haemopathy) for whom a first line treatment is envisaged (whatever it is). Surgery and radiotherapy are allowed before entry into the study.
Patient candidate for oncogeriatric assessment
Patient agree to participate in the study
Using the French language
Exclusion Criteria:
Primary central nervous system or cerebral metastasis
Evolutionary psychiatric pathology known (e.g. schizophrenia)
Severe Visual and / or Auditory Impairment
Patients unable to respond to cognitive tests
Patient (s) deprived of liberty, under guardianship or curatorship
Refusal of participation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
florence JOLY, prof
Organizational Affiliation
Centre François Baclesse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre François Baclesse
City
Caen
Country
France
Facility Name
CHU
City
Caen
Country
France
Facility Name
CH
City
Cherbourg
Country
France
Facility Name
Ch Compiegne
City
Compiègne
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
Country
France
Facility Name
Centre Hospitalier
City
Saint-Lô
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
MoCA vs. MMS: Which Tool to Detect Cognitive Disorders in Oncogeriatric?
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