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

Cancer Pain Clinical Trial

Official title:

DPRESS Study. Case-control Study in Cancer Pain: Uncontrolled Pain as Depression Development Predictor in Oncologic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01402830
• Other study ID #: CR017656
• Secondary ID: FENPAI4055
• Status: Completed
• Phase: Phase 4
• First received: July 25, 2011
• Last updated: February 8, 2013
• Start date: November 2007
• Est. completion date: March 2008

Study information

• Verified date: February 2013
• Source: Janssen-Cilag, S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Drug Agency
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 271
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cancer Pain

Intervention

Other:
• Visual analogue scales (EVAs)
This scale measures the pain intensity.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag, S.A.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beck Depression Inventory		3 months	No
Primary	Visual scales analog (EVAs)		3 months	No
Secondary	Number of patients with cancer pain.		3 months	No