Comparison of Mood Disorders Screening Scales in Geriatric Oncology (Thymog)

August 16, 2017 updated by: University Hospital, Caen

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

Completed

Conditions

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

Observational

Enrollment (Actual)

93

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Caen, France, 14033
        • Caen UH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Men and women 70 years and older with newly diagnosed or relapsed cancer or haematological malignancies (not older than one month)

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

April 1, 2016

First Submitted That Met QC Criteria

June 9, 2016

First Posted (Estimate)

June 15, 2016

Study Record Updates

Last Update Posted (Actual)

August 21, 2017

Last Update Submitted That Met QC Criteria

August 16, 2017

Last Verified

January 1, 2017

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)?

NO

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.

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