Thymog: Comparison of Mood Disorders Screening Scales in Geriatric Oncology

Sponsor
University Hospital, Caen (Other)
Overall Status
Completed
CT.gov ID
NCT02799524
Collaborator
Centre Francois Baclesse (Other)
93
1
19
4.9

Study Details

Study Description

Brief 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 .

Condition or Disease Intervention/Treatment Phase
  • Other: comparison of screening scales

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

Study Type:
Observational
Actual Enrollment :
93 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Comparison of Mood Disorders Screening Scales in Geriatric Oncology
Study Start Date :
Dec 1, 2015
Actual Primary Completion Date :
Dec 1, 2016
Actual Study Completion Date :
Jul 1, 2017

Outcome Measures

Primary Outcome Measures

  1. Concordance degrees Assessment (HADS and GDS ) [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

Secondary Outcome Measures

  1. Correlation between the presence of signs of depression screening by HADS -D ( ≥11 / 21) and GDS ( > 5/15) [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

  2. correlation between anxious signs of HADS -A ( ≥11 / 21) and the distress thermometer ( ≥4 / 10) and factors outcome 2 [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. Comparison of the distress thermometer score between screening and revaluation to 3 weeks [3 weeks]

    Comparison of the distress thermometer score between screening and revaluation to 3 weeks

Eligibility Criteria

Criteria

Ages Eligible for Study:
70 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Caen UH Caen France 14033

Sponsors and Collaborators

  • University Hospital, Caen
  • Centre Francois Baclesse

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT02799524
Other Study ID Numbers:
  • 2015-A00836-43
  • 15-087
First Posted:
Jun 15, 2016
Last Update Posted:
Aug 21, 2017
Last Verified:
Jan 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 21, 2017