DepressionCADEPONCT05681793
Survey on the Clinical Assessment of the Psychological Status of a Patient Over 75 Years Old in Oncology During the Realization of the G8 Score (CADEPO)
An observational study of Depression, run by Hopital Nord Franche-Comte at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 to 95 years
- Conditions the study is for
- Depression
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jan 2023to 2 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 to 95 years
- All sexes
- No healthy volunteers
- Older adult
Study population: All patients over 75 presenting eligibility criteria and undergoing oncological treatment and coming for consultation in the Hôpital Nord Franche-Comté
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Survey on the Clinical Assessment of the Psychological Status of a Patient Over 75 Years Old in Oncology During the Realization of the G8 Score
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:
Read more
- 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.
- Conditions
- Depression
- Medical subject headings
- Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 months
Secondary outcomes (3)
Evaluation of the number of patients over 75 on antidepressants included in this study
Percentage of patients included in this study and being treated with antidepressants
Measured: 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
Percentage of patients with depressive symptoms according to the predisposing factors (age, gender, housing in urban or rural areas,distance (in travel time) between the oncology department and home, social isolation, income, marital status, socio-professional category, type of cancer), taken from a sociodemographic sheet distributed to the patient and from the medical file
Measured: 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
Percentage 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
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start17 Jan 2023
- Primary completion2 Mar 2023
- Study completion2 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Nord Franche-Comte
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05681793
- Sponsor's protocol ID
- 2022-A02329-34
- Acronym
- CADEPO
- Status last verified
- Jun 2023
- First submitted
- 28 Dec 2022
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey on the Clinical Assessment of the Psychological Status of a Patient Over 75 Years Old in Oncology During the Realization of the G8 Score
- ClinicalTrials.gov ID
- NCT05681793
- Acronym / sponsor ID
- CADEPO / 2022-A02329-34
- Conditions
- Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hopital Nord Franche-ComteUniversity, hospital or other
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 2 Mar 2023 (actual)
- Study completion
- 2 Apr 2023 (actual)
- First posted
- 12 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 75 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- All patients over 75 presenting eligibility criteria and undergoing oncological treatment and coming for consultation in the Hôpital Nord Franche-Comté
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: 2 months
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).
3 secondary outcomes
Evaluation of the number of patients over 75 on antidepressants included in this study
Time frame: 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
Time frame: 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
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, run by Hopital Nord Franche-Comte at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.