NCT01402830

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
271

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2007

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 26, 2011

Completed
Last Updated

February 11, 2013

Status Verified

February 1, 2013

Enrollment Period

4 months

First QC Date

July 25, 2011

Last Update Submit

February 8, 2013

Conditions

Cancer Pain

Keywords

cancerdepressionpain

Outcome Measures

Primary Outcomes (2)

  • Beck Depression Inventory

    3 months

  • Visual scales analog (EVAs)

    3 months

Secondary Outcomes (1)

  • Number of patients with cancer pain.

    3 months

Study Arms (1)

001

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

Other: Visual analogue scales (EVAs)

Interventions

Visual analogue scales (EVAs)OTHER

This scale measures the pain intensity.

001

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with cancer pain who experience depression and pain after cancer diagnosis

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cancer PainNeoplasmsDepressionPain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Study Officials

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

    Janssen-Cilag, S.A.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2011

First Posted

July 26, 2011

Study Start

November 1, 2007

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

February 11, 2013

Record last verified: 2013-02