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

NCT ID: NCT01402830

Last Updated: 2013-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

271 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-03-31

Brief Summary

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

Detailed Description

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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

Conditions

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Cancer Pain

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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001

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

Visual analogue scales (EVAs)

Intervention Type OTHER

This scale measures the pain intensity.

Interventions

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Visual analogue scales (EVAs)

This scale measures the pain intensity.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen-Cilag, S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag, S.A.

Other Identifiers

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FENPAI4055

Identifier Type: -

Identifier Source: secondary_id

CR017656

Identifier Type: -

Identifier Source: org_study_id

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