PainNCT01829828
The Effectiveness of a Patient Self-reported Pain Scoring Tool and a Satisfaction Survey on Cancer Pain Management
An observational study of Pain, run by Janssen Korea, Ltd., Korea.
Trial summary
The purpose of this survey is to investigate the usefulness of a patient self-reported scoring tool on patient satisfaction improvement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 587 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to May 2012
- 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: Inpatients admitted for cancer pain management
Who may be able to join
- Patients who have no experience with the study self-reported pain scoring tool
- Patients who are able to understand and answer the pain scoring tool questions
- Patients admitted to a hospital for more than 5 days due to cancer pain
- Patients for whom their pain managing physicians completed the medical staff's survey
Who cannot join
- Patients who cannot answer the questions due to cognitive impairments
About this study
Official title: To Evaluate the Effectiveness of a Patient Self-reported Pain Scoring Tool and a Satisfaction Survey on Cancer Pain Management; Multicenter, Cross-sectional Study
The purpose of this survey is to investigate the usefulness of a patient self-reported scoring tool on patient satisfaction improvement.
- Conditions
- Pain
- Being tested
- No intervention
- Keywords
- Pain, Cancer pain, Self-reported pain scoring tool, Opioid analgesics
- Medical subject headings
- Pain, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionBehavioural
This is an observational study with no investigational drug administered.
| Study group | Role | What they receive |
|---|---|---|
| Inpatients with cancer pain | Inpatients admitted for cancer pain management Receives: Behavioral: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction with the control of cancer-related pain
Patients will answer on a 7-point scale how satisfied they feel about their cancer pain treatment. The scale scores range from 1 (not at all satisfied) to 7 (very much satisfied).
Measured: At baseline
Secondary outcomes (2)
Patient perception of pain
Patients will answer on an 11-point scale how much pain they feel. The scales scores range from 0 (no pain at all) to 10 (pain as bad as you can imagine).
Measured: At baseline
Patient pain assessment by medical staff
The patient's physician will mark on an 11-point scale the intensity of the patient pain. The scale scores range from 0 (no pain at all) to 10 (pain as bad as you can imagine).
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2013 (estimated)
- Study startJan 2012
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 587 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Korea, Ltd., Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Korea, Ltd., Korea Clinical Trial, Study director, Janssen Korea, Ltd., Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01829828
- Sponsor's protocol ID
- CR100835
- Other IDs
- FENPAI4097, FEN-KOR-9052
- Status last verified
- Apr 2013
- First submitted
- 8 Apr 2013
- Last updated
- 11 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Effectiveness of a Patient Self-reported Pain Scoring Tool and a Satisfaction Survey on Cancer Pain Management; Multicenter, Cross-sectional Study
- ClinicalTrials.gov ID
- NCT01829828
- Acronym / sponsor ID
- CR100835
- Conditions
- Pain
- Keywords
- Pain, Cancer pain, Self-reported pain scoring tool, Opioid analgesics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 587 participants (actual)
- Lead sponsor
- Janssen Korea, Ltd., KoreaIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 11 Apr 2013 (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 survey is to investigate the usefulness of a patient self-reported scoring tool on patient satisfaction improvement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inpatients with cancer pain | – | Behavioral: No interventionInpatients admitted for cancer pain management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatients admitted for cancer pain management
Key inclusion criteria (4 listed)
- Patients who have no experience with the study self-reported pain scoring tool
- Patients who are able to understand and answer the pain scoring tool questions
- Patients admitted to a hospital for more than 5 days due to cancer pain
- Patients for whom their pain managing physicians completed the medical staff's survey
Key exclusion criteria (1 listed)
- Patients who cannot answer the questions due to cognitive impairments
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 |
|---|---|---|
| No interventionThis is an observational study with no investigational drug administered. | Behavioural | Inpatients with cancer pain |
Primary outcome
Patient satisfaction with the control of cancer-related pain
Time frame: At baseline
Patients will answer on a 7-point scale how satisfied they feel about their cancer pain treatment. The scale scores range from 1 (not at all satisfied) to 7 (very much satisfied).
2 secondary outcomes
Patient perception of pain
Time frame: At baseline
Patient pain assessment by medical staff
Time frame: At baseline
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 Apr 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 Korea, Ltd., Korea Clinical Trial study director
Janssen Korea, Ltd., Korea
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Janssen Korea, Ltd., Korea.
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 4 inclusion and 1 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 Apr 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?
Patient satisfaction with the control of cancer-related pain (time frame: At baseline). 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 Apr 2013.