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

Completed

• Conditions: Cancer Pain
• Interventions: Other: Visual analogue scales (EVAs)

• Registration Number: NCT01402830
• Lead Sponsor: Janssen-Cilag, S.A.

Brief Summary

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

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

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Study First Submitted: 2011-07-25
• Study First Submitted QC: 2011-07-25
• Study First Posted: 2011-07-26
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-08
• Last Update Posted: 2013-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 271

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
001	Visual analogue scales (EVAs)	Visual analogue scales (EVAs) This scale measures the pain intensity.

Primary Outcome Measures

Name	Time	Method
Beck Depression Inventory	3 months
Visual scales analog (EVAs)	3 months

Secondary Outcome Measures

Name	Time	Method
Number of patients with cancer pain.	3 months