Text Size

Evaluation of States in Major Depressive Patients With Cancer, Hospitalized in a Hospital Palliative (DECAPAL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Francois Baclesse
ClinicalTrials.gov Identifier:
NCT01593085
First received: April 30, 2012
Last updated: February 5, 2013
Last verified: April 2012
History of Changes
  Purpose

The investigators propose a study that aims to develop a methodology for assessing this risk and the psychological consequences of the malignancy in the palliative phase.


Condition Intervention
Cancer
 Behavioral: interview with a doctor for evaluating suicide risk

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of States in Major Depressive Patients With Cancer, Hospitalized in a Hospital Palliative

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre Francois Baclesse:

Primary Outcome Measures:
  • assessing the prevalence of suicide risk in patients with cancer admitted to a palliative care service. [ Time Frame: at inclusion only, during hospitalization in palliative cares ] [ Designated as safety issue: No ]
    assessing the prevalence of suicide risk in patients with cancer admitted to a palliative care service.


Secondary Outcome Measures:
  • Evaluate the feasibility of a methodology for estimating the risk of suicide in patients with cancer admitted to a palliative care service [ Time Frame: at inclusion only, during hospitalization in palliative cares ] [ Designated as safety issue: No ]
    Evaluate the feasibility of a methodology for estimating the risk of suicide in patients with cancer admitted to a palliative care service Questionnaires used are HADS Questionary, Scale HAMILTON, Scale BECK and Scale DUCHER

  • Assess the psychological impact of cancer pathology in patients in palliative [ Time Frame: at inclusion only, during hospitalization in palliative cares ] [ Designated as safety issue: No ]
    Assess the psychological impact of cancer pathology in patients in palliative by evaluating depression score (with HADS HAMILTON, BECK, DUCHER scales)

  • Identify risk factors for suicide in this patient population [ Time Frame: at inclusion only, during hospitalization in palliative cares ] [ Designated as safety issue: No ]
    Identify risk factors for suicide in this patient population with evaluation of type of cancer, psychiatric history, family and social context, quality of life


Enrollment: 55
Study Start Date: April 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
patients in palliative cares
patients with cancer in palliative cares An interview and will be offered to this patient during his hospitalization to be held (with the collection of personal and family psychiatric history of the patient, family and social context, the assessment of chronic pain and fatigue and quality of life,assessment of anxiety, Evaluation of symptoms of depression,asessment of suicide risk)
 Behavioral: interview with a doctor for evaluating suicide risk

patients with cancer in palliative cares An interview and will be offered to this patient during his hospitalization to be held (with the collection of personal and family psychiatric history of the patient, family and social context, the assessment of chronic pain and fatigue and quality of life,assessment of anxiety, Evaluation of symptoms of depression,asessment of suicide risk)

--------------------------------------------------------------------------------

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with cancer in palliative cares

Criteria

Inclusion Criteria:

  • Patient (s) age (s) 18 or more
  • Patient (s) reach (s) of a cancer palliative stage
  • Patient (s) hospital (s) in the palliative care service
  • Patient (s) with cognitive function to an interrogation
  • Patient (s) having a physical condition for an interview lasting 45 minutes
  • Patient (s) that received clear information on the diagnosis and prognosis of their disease.
  • Free and informed consent signed

Exclusion Criteria:

  • Patient (s) age (s) under 18 years
  • Patient (s) under supervision or unable to give informed consent
  • Patient (s) whose cognitive functions do not allow an examination.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01593085

Locations
France
Centre François BACLESSE
Caen, Calvados, France, 14076
Sponsors and Collaborators
Centre Francois Baclesse
Investigators
Principal Investigator: Marie-Christine GRACH, MD Centre François Baclesse
  More Information

No publications provided

Responsible Party: Centre Francois Baclesse
ClinicalTrials.gov Identifier: NCT01593085     History of Changes
Other Study ID Numbers: DECAPAL
Study First Received: April 30, 2012
Last Updated: February 5, 2013
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

Keywords provided by Centre Francois Baclesse:
palliative cares
cancer
suicide risk

ClinicalTrials.gov processed this record on May 16, 2013