NCT05681793

Brief Summary

The goal of this observational study is to make a statement concerning the identification of depressive symptoms at the time of the realization of the G8 score in patients over 75 with cancer and followed in oncology. The main question it aims to answer are:

  • Compare the medical hetero-evaluation of depressive symptoms via the G8 "neuro-psychiatric disorders" item score with a self-evaluation via the GDS-15 score
  • Evaluate the number of patients over 75 treated with antidepressants
  • Evaluate the proportion of patients with depressive symptoms according to the predisposing factors
  • Compare the number of patients followed in oncogeriatrics over the period from 01/01/2022 to 02/28/2022 and the period from 01/01/2023 to 02/28/2023 Participants will complete a self-questionnaire (GDS-15 score) as well as a socio-demographic sheet.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 12, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

January 17, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2023

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

1 month

First QC Date

December 28, 2022

Last Update Submit

June 20, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Comparison the medical hetero-evaluation of depressive symptoms via the G8 "neuro-psychiatric disorders" item score with a self-evaluation via the GDS-15 score, in patients over 75 years of age with cancer and follow-up in oncology

    Difference between the evaluation of the health professionals of the item "Neuropsychiatric problems" of the G8 score (no depression versus moderate or severe depression) and the responses of the patients to the self-administered questionnaire GDS-15 (Geriatric Depression Scale) ( 0 to 4: normal versus 5 to 15: moderate to severe depression).

    2 months

Secondary Outcomes (3)

  • Evaluation of the number of patients over 75 on antidepressants included in this study

    2 months

  • Evaluation of the proportion of patients with depressive symptoms according to the predisposing factors with a sociodemographic sheet and from the medical file

    2 months

  • Compare the number of patients followed in oncogeriatrics over the period from 01/01/22 to 02/28/22 and the period from 01/01/2023 to 02/28/2023

    2 months

Eligibility Criteria

Age75 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients over 75 presenting eligibility criteria and undergoing oncological treatment and coming for consultation in the Hôpital Nord Franche-Comté

You may qualify if:

  • Patients aged 75 and over
  • Patients receiving treatment at the day hospital or oncology week hospital
  • Patients informed and having not presented any opposition to their participation

You may not qualify if:

  • Patients under the age of 75
  • Patients under guardianship or curatorship
  • Patients without social security
  • Cognitive disorders compromising the understanding of the information and the performance of the study (in particular the completion of a self-administered questionnaire), in the opinion of the oncologist

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Nord Franche-Comté

Trévenans, 90400, France

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2022

First Posted

January 12, 2023

Study Start

January 17, 2023

Primary Completion

March 2, 2023

Study Completion

April 2, 2023

Last Updated

June 22, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations