Cancer PainNCT01402830
Case-control Study- Cancer Pain: Uncontrolled Pain as Depression Development Predictor in Oncologic Patients (Fentanyl)
An observational study of Cancer Pain, run by Janssen-Cilag, S.A..
Trial summary
The purpose of this study is to evaluate the relationship between cancer pain and risk of depression among cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Pain
- What is being tested?
- Visual analogue scales (EVAs)
- How many people
- 271 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to Mar 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with cancer pain who experience depression and pain after cancer diagnosis
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: DPRESS Study. Case-control Study in Cancer Pain: Uncontrolled Pain as Depression Development Predictor in Oncologic Patients
The purpose of this study is to evaluate the relationship between cancer pain and risk of depression among cancer patients.
Read the 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
- Conditions
- Cancer Pain
- Being tested
- Visual analogue scales (EVAs)
- Keywords
- cancer, depression, pain
- Medical subject headings
- Cancer Pain, Neoplasms, Depression, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual analogue scales (EVAs)Other
This scale measures the pain intensity.
| Study group | Role | What they receive |
|---|---|---|
| 001 | Visual analogue scales (EVAs) This scale measures the pain intensity. Receives: Other: Visual analogue scales (EVAs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory
Measured: 3 months
Visual scales analog (EVAs)
Measured: 3 months
Secondary outcomes (1)
Number of patients with cancer pain.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2011 (estimated)
- Study startNov 2007
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial, Study director, Janssen-Cilag, S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01402830
- Sponsor's protocol ID
- CR017656
- Other IDs
- FENPAI4055
- Status last verified
- Feb 2013
- First submitted
- 25 Jul 2011
- Last updated
- 11 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DPRESS Study. Case-control Study in Cancer Pain: Uncontrolled Pain as Depression Development Predictor in Oncologic Patients
- ClinicalTrials.gov ID
- NCT01402830
- Acronym / sponsor ID
- CR017656
- Conditions
- Cancer Pain
- Keywords
- cancer, depression, pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- Janssen-Cilag, S.A.Industry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 26 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 001 | – | Other: Visual analogue scales (EVAs)Visual analogue scales (EVAs) This scale measures the pain intensity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with cancer pain who experience depression and pain after cancer diagnosis
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual analogue scales (EVAs)This scale measures the pain intensity. | Other | 001 |
Primary outcome
Beck Depression Inventory
Time frame: 3 months
Visual scales analog (EVAs)
Time frame: 3 months
1 secondary outcome
Number of patients with cancer pain.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial study director
Janssen-Cilag, S.A.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Pain, run by Janssen-Cilag, S.A..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Depression Inventory (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2013.