Mood DisordersThymogNCT02799524
Comparison of Mood Disorders Screening Scales in Geriatric Oncology
An observational study of Mood Disorders, run by University Hospital, Caen at 1 site in France.
Trial summary
The objective of this study is to evaluate the scales commonly used in geriatrics and oncology distress thermometer ( analogue scale rated from 0 to 1 for the emotional distress ) , the GDS15 (15 issues closed binary response seeking signs of depression ) the HADS (14 questions assessing the intensity of anxiety signs… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Mood Disorders
- What is being tested?
- comparison of screening scales
- How many people
- 93 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2015to Jul 2017
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Men and women 70 years and older with newly diagnosed or relapsed cancer or haematological malignancies (not older than one month)
Who may be able to join
- Patient 70 years and older with diagnosis of cancer or haematological malignancies ,
- New diagnosis or relapse announced
- Supported in the 2 c among : in consultation , or hospital geriatric or oncology / hematology specialty
- Affiliated Health Insurance
Who cannot join
- Cognitive problems preventing self
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to evaluate the scales commonly used in geriatrics and oncology distress thermometer ( analogue scale rated from 0 to 1 for the emotional distress ) , the GDS15 (15 issues closed binary response seeking signs of depression ) the HADS (14 questions assessing the intensity of anxiety signs and signs of depression listed 0-3 ).
The prospective observational study will be conducted in parallel on two sites ( University Hospital Centre and François Baclesse ) after informed patient information.
It will be offered to patients 70 years and over with a new diagnosis or relapse of cancer or haematological malignancies in the hospital to meet the mood disorder screening questionnaires .
Read the detailed description
There are various tools validated and recommended by the SiO and SFPO for screening mood disorders in geriatric oncology . The choice among them depends on the usual practices of the various teams , only some scales assessing depressive signs and other signs of anxiety too. None were assessed in a population aged diagnosis of cancer or hematologic malignancy in pre- therapeutic situation.
The objective of this study is to evaluate the scales commonly used in geriatrics and oncology distress thermometer ( analogue scale rated from 0 to 1 for the emotional distress ) , the GDS15 (15 issues closed binary response seeking signs of depression ) the HADS (14 questions assessing the intensity of anxiety signs and signs of depression listed 0-3 ) The prospective observational study will be conducted in parallel on two sites ( University Hospital Centre and François Baclesse ) after informed patient information.
It will be offered to patients 70 years and over with a new diagnosis or relapse of cancer or haematological malignancies in the hospital to meet the mood disorder screening questionnaires .
If one test is abnormal , a clinical psychological care will be offered . When returning home : telephone contact will be made the same day with the doctor , asking him to please make thymic revaluation within 2 weeks ( informed patient). It will be sent to the doctor by post a rubric of Major Depressive Episode criteria of the DSM V to return . If the patient remains hospitalized , the doctor taking care of patient will be contacted to obtain the same information .
In addition, the investigators will study the impact on the management (change or introduction of an antidepressant and / or anxiolytic use of psychotherapy or psychological counseling ... ) to 5 weeks
- Conditions
- Mood Disorders
- Being tested
- comparison of screening scales
- Medical subject headings
- Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comparison of screening scalesOther
Concordance degrees Assessment of each of 2 scales ( HADS and GDS ) from the DSM- V , for diagnostic confirmation of major depressive episodes in elderly patients with cancer or haematological malignancies
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance degrees Assessment (HADS and GDS )
Concordance degrees Assessment of each of 2 scales ( HADS and GDS ) from the DSM- V , for diagnostic confirmation of major depressive episodes in elderly patients with cancer or haematological malignancies
Measured: 3 weeks
Secondary outcomes (3)
Correlation between the presence of signs of depression screening by HADS -D ( ≥11 / 21) and GDS ( > 5/15)
Correlation between the presence of signs of depression screening by HADS -D ( ≥11 / 21) and GDS ( > 5/15) with the following factors: the type of cancer, concept of relapse, there is an oncologic therapeutic project or no , sex , social status, loss of autonomy, presence of pain , severe comorbidities ( CIRS - G≥3 ) , psychiatric history , psychotropic treatment ( anxiolytic , antidepressant) in place
Measured: 3 weeks
correlation between anxious signs of HADS -A ( ≥11 / 21) and the distress thermometer ( ≥4 / 10) and factors outcome 2
correlation between anxious signs of HADS -A ( ≥11 / 21) and the distress thermometer ( ≥4 / 10) and the type of cancer, concept of relapse, oncologic therapeutic project or no, sex, social status, loss of autonomy, presence of pain, severe comorbidities, psychiatric history , psychotropic treatment in place
Measured: 3 weeks
Comparison of the distress thermometer score between screening and revaluation to 3 weeks
Comparison of the distress thermometer score between screening and revaluation to 3 weeks
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2016
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mood DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Francois Baclesse
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02799524
- Sponsor's protocol ID
- 2015-A00836-43
- Other IDs
- 15-087
- Acronym
- Thymog
- Status last verified
- Jan 2017
- First submitted
- 1 Apr 2016
- Last updated
- 21 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Mood Disorders Screening Scales in Geriatric Oncology
- ClinicalTrials.gov ID
- NCT02799524
- Acronym / sponsor ID
- Thymog / 2015-A00836-43
- Conditions
- Mood Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- Centre Francois Baclesse
- Study start
- Dec 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 15 Jun 2016 (estimated)
- 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 objective of this study is to evaluate the scales commonly used in geriatrics and oncology distress thermometer ( analogue scale rated from 0 to 1 for the emotional distress ) , the GDS15 (15 issues closed binary response seeking signs of depression ) the HADS (14 questions assessing the intensity of anxiety signs and signs of depression listed 0-3 ).
The prospective observational study will be conducted in parallel on two sites ( University Hospital Centre and François Baclesse ) after informed patient information.
It will be offered to patients 70 years and over with a new diagnosis or relapse of cancer or haematological malignancies in the hospital to meet the mood disorder screening questionnaires .
Detailed description
There are various tools validated and recommended by the SiO and SFPO for screening mood disorders in geriatric oncology . The choice among them depends on the usual practices of the various teams , only some scales assessing depressive signs and other signs of anxiety too. None were assessed in a population aged diagnosis of cancer or hematologic malignancy in pre- therapeutic situation.
The objective of this study is to evaluate the scales commonly used in geriatrics and oncology distress thermometer ( analogue scale rated from 0 to 1 for the emotional distress ) , the GDS15 (15 issues closed binary response seeking signs of depression ) the HADS (14 questions assessing the intensity of anxiety signs and signs of depression listed 0-3 ) The prospective observational study will be conducted in parallel on two sites ( University Hospital Centre and François Baclesse ) after informed patient information.
It will be offered to patients 70 years and over with a new diagnosis or relapse of cancer or haematological malignancies in the hospital to meet the mood disorder screening questionnaires .
If one test is abnormal , a clinical psychological care will be offered . When returning home : telephone contact will be made the same day with the doctor , asking him to please make thymic revaluation within 2 weeks ( informed patient). It will be sent to the doctor by post a rubric of Major Depressive Episode criteria of the DSM V to return . If the patient remains hospitalized , the doctor taking care of patient will be contacted to obtain the same information .
In addition, the investigators will study the impact on the management (change or introduction of an antidepressant and / or anxiolytic use of psychotherapy or psychological counseling ... ) to 5 weeks
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Men and women 70 years and older with newly diagnosed or relapsed cancer or haematological malignancies (not older than one month)
Key inclusion criteria (4 listed)
- Patient 70 years and older with diagnosis of cancer or haematological malignancies ,
- New diagnosis or relapse announced
- Supported in the 2 c among : in consultation , or hospital geriatric or oncology / hematology specialty
- Affiliated Health Insurance
Key exclusion criteria (1 listed)
- Cognitive problems preventing self
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| comparison of screening scalesConcordance degrees Assessment of each of 2 scales ( HADS and GDS ) from the DSM- V , for diagnostic confirmation of major depressive episodes in elderly patients with cancer or haematological malignancies | Other | – |
Primary outcome
Concordance degrees Assessment (HADS and GDS )
Time frame: 3 weeks
Concordance degrees Assessment of each of 2 scales ( HADS and GDS ) from the DSM- V , for diagnostic confirmation of major depressive episodes in elderly patients with cancer or haematological malignancies
3 secondary outcomes
Correlation between the presence of signs of depression screening by HADS -D ( ≥11 / 21) and GDS ( > 5/15)
Time frame: 3 weeks
correlation between anxious signs of HADS -A ( ≥11 / 21) and the distress thermometer ( ≥4 / 10) and factors outcome 2
Time frame: 3 weeks
Comparison of the distress thermometer score between screening and revaluation to 3 weeks
Time frame: 3 weeks
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 21 Aug 2017.
- 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 Mood Disorders, run by University Hospital, Caen 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 4 inclusion and 1 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 21 Aug 2017. 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?
Concordance degrees Assessment (HADS and GDS ) (time frame: 3 weeks). 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 21 Aug 2017.