Comparison of Mood Disorders Screening Scales in Geriatric Oncology

Mood Disorders Clinical Trial

— Thymog  

Official title:

Comparison of Mood Disorders Screening Scales in Geriatric Oncology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02799524
• Other study ID #: 2015-A00836-43
• Secondary ID: 15-087
• Status: Completed
• Phase: N/A
• First received: April 1, 2016
• Last updated: August 16, 2017
• Start date: December 2015
• Est. completion date: July 2017

Study information

• Verified date: January 2017
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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 .

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: July 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Mood Disorders

Intervention

Other:
• comparison of screening scales
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

Locations

Country	Name	City	State
France	Caen UH	Caen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Caen	Centre Francois Baclesse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 weeks
Secondary	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	3 weeks
Secondary	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	3 weeks
Secondary	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	3 weeks