- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02799524
Comparison of Mood Disorders Screening Scales in Geriatric Oncology (Thymog)
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 .
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Caen, France, 14033
- Caen UH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Cognitive problems preventing self
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between the presence of signs of depression screening by HADS -D ( ≥11 / 21) and GDS ( > 5/15)
Time Frame: 3 weeks
|
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
|
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
|
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
|
3 weeks
|
Comparison of the distress thermometer score between screening and revaluation to 3 weeks
Time Frame: 3 weeks
|
Comparison of the distress thermometer score between screening and revaluation to 3 weeks
|
3 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-A00836-43
- 15-087 (Other Identifier: CHU Caen)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mood Disorders
-
Université du Québec a MontréalCiusss de L'Est de l'Île de Montréal; PhysioExtra; EnergirRecruitingDepression ; Anxiety With Depressed Mood ; Mood Disorder, Adjustment Disorder With Depressed MoodCanada
-
Joliet Center for Clinical ResearchAbbottCompleted
-
National Institute of Mental Health (NIMH)Completed
-
National Institute of Mental Health (NIMH)Completed
-
University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)Completed
-
University of Colorado, DenverCompletedMood Disorders | Irritable MoodUnited States
-
VA Office of Research and DevelopmentCompleted
-
Baskent UniversityZİYAFET UĞURLURecruitingDisaster; Personality | Disorder, MoodTurkey
-
Fayoum University HospitalCompletedKetamine-Induced Mood DisorderEgypt
-
Mayo ClinicCompletedMood Disorders in Children and AdolescentsUnited States
Clinical Trials on comparison of screening scales
-
AstesCompletedSleep Apnea, ObstructiveBelgium
-
University College London HospitalsCompleted
-
Aberdeen Royal InfirmaryCompletedBreast CancerUnited Kingdom
-
SonoCine, Inc.UnknownBreast Neoplasms | UltrasonographyUnited States
-
Jonsson Comprehensive Cancer CenterCompleted
-
Jewish Hospital and St. Mary's HealthcareUnknownLung CancerUnited States
-
Fox Chase Cancer CenterNational Cancer Institute (NCI)Withdrawn
-
Gloucestershire Hospitals NHS Foundation TrustUnknownEsophageal Cancer | Precancerous ConditionUnited Kingdom
-
Universidade da CoruñaRecruitingLigament Rupture | Ligament Injury | Ligament DisordersPortugal
-
US Department of Veterans AffairsNational Cancer Institute (NCI)UnknownEsophageal Cancer | Precancerous ConditionUnited States