NCT02799524

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 15, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

August 21, 2017

Status Verified

January 1, 2017

Enrollment Period

1 year

First QC Date

April 1, 2016

Last Update Submit

August 16, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

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

    3 weeks

  • correlation between anxious signs of HADS -A ( ≥11 / 21) and the distress thermometer ( ≥4 / 10) and factors outcome 2

    3 weeks

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

    3 weeks

Interventions

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

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • 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

You may not qualify if:

  • Cognitive problems preventing self

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caen UH

Caen, 14033, France

Location

MeSH Terms

Conditions

Mood Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2016

First Posted

June 15, 2016

Study Start

December 1, 2015

Primary Completion

December 1, 2016

Study Completion

July 1, 2017

Last Updated

August 21, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations