Case-control Study- Cancer Pain: Uncontrolled Pain as Depression Development Predictor in Oncologic Patients (Fentanyl)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag, S.A.
ClinicalTrials.gov Identifier:
NCT01402830
First received: July 25, 2011
Last updated: February 8, 2013
Last verified: February 2013
  Purpose

The purpose of this study is to evaluate the relationship between cancer pain and risk of depression among cancer patients.


Condition Intervention Phase
Cancer Pain
Other: Visual analogue scales (EVAs)
Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: DPRESS Study. Case-control Study in Cancer Pain: Uncontrolled Pain as Depression Development Predictor in Oncologic Patients

Resource links provided by NLM:


Further study details as provided by Janssen-Cilag, S.A.:

Primary Outcome Measures:
  • Beck Depression Inventory [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Visual scales analog (EVAs) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients with cancer pain. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 271
Study Start Date: November 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
001
Visual analogue scales (EVAs) This scale measures the pain intensity.
Other: Visual analogue scales (EVAs)
This scale measures the pain intensity.

Detailed Description:

This is a retrospective observational and case-control multicenter study. The main objective of this study is determine the degree of association between cancer pain and depression by impact assessment of adequate control of pain associated with cancer risk depression in patients attending the Oncology Unit. The assessment of pain intensity will be performed by using visual analogue scales (EVAs) and verbal descriptive scales, as an observational study, not limit or modify the use of any drug. The patients included in this study have a medical history of cancer pain and mild depression (Beck = 8). The controls are patients with history of cancer pain and mild or absent depression (Beck = 7). n/a

  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 pain who experience depression and pain after cancer diagnosis

Criteria

Inclusion Criteria:

  • Patients =18 years old
  • have medical data of = 3 months
  • experience pain after cancer diagnosis and complete the Beck Depression Inventory (BDI)
  • patients who give informed written consent
  • patients with no mental or physical disorders that unable them to complete the BDI.

Exclusion Criteria:

  • Patients with diagnosis of depression before cancer diagnosis
  • patients with chronic pain prior to the diagnosis of cancer, and cancer disease has not changed its course
  • patients with other previous mental disorders
  • patients who do not give their informed written consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01402830

Sponsors and Collaborators
Janssen-Cilag, S.A.
Investigators
Study Director: Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial Janssen-Cilag, S.A.
  More Information

No publications provided

Responsible Party: Janssen-Cilag, S.A.
ClinicalTrials.gov Identifier: NCT01402830     History of Changes
Other Study ID Numbers: CR017656, FENPAI4055
Study First Received: July 25, 2011
Last Updated: February 8, 2013
Health Authority: Spain: Spanish Drug Agency

Keywords provided by Janssen-Cilag, S.A.:
cancer
depression
pain

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 27, 2014