Cancers, PainPhase 4NCT01043068
The Effect of Cancer Pain Management Protocol on Hospitalized Cancer Patients: A Pilot Study
A Phase 4 study testing Cancer pain management in people with Cancers, Pain, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
The purpose of this study was to prospectively evaluate the effect of cancer pain management protocol on hospitalized cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancers, Pain
- What is being tested?
- Cancer pain management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2010to Dec 2010
- Phase
- Phase 4
- 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
Who may be able to join
- Hospitalized patient with the somatic and/or visceral pain having an untreated intensity greater than 3 on a 10 cm visual analog scale (VAS; 0 = no pain, 10 = unbearable pain)over the week prior to enrollment
- A minimum age of 18 years
Who cannot join
- Opioid intolerance
- No longer treatment for their underlying disease.
- Intracerebral primary or metastatic lesion
- Impaired sensory or cognitive function
- Pregnant or lactating woman
- Women of child bearing potential not using a contraceptive method
- Sexually active fertile men not using effective birth control during medication of study drug and up to 6 months after completion of study drug if their partners are women of child-bearing potential
- Any patients judged by the investigator to be unfit to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study: The Effect of Cancer Pain Management Protocol on Hospitalized Cancer Patients
The purpose of this study was to prospectively evaluate the effect of cancer pain management protocol on hospitalized cancer patients.
- Conditions
- Cancers, Pain
- Being tested
- Cancer pain management
- Keywords
- cancer pain, opioid, guideline
- Medical subject headings
- Neoplasms, Pain, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cancer pain managementDrug
Interventions based on published pain guideline. The interventions consisted of the following: (1) nursing pain assessment of current pain, worst pain, pain relief, and acceptability of pain; (2) feedback to guide analgesic prescribing by physician.
| Study group | Role | What they receive |
|---|---|---|
| Pain control | Experimental | Interventions based on published pain guideline. The interventions consisted of the following: (1) nursing pain assessment of current pain, worst pain, pain relief, and acceptability of pain; (2) feedback to guide analgesic prescribing by physician. Receives: Drug: Cancer pain management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in pain scores
Measured: Jan 2010 - October 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancers, 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Collaborators
- Janssen Korea, Ltd., Korea
- Responsible party
- Principal investigator, Sang Myung Woo, National Cancer Center, Korea
- Investigators
- Dae Hyun Kim, Prof, Principal investigator, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01043068
- Sponsor's protocol ID
- CAPAM-1
- Status last verified
- Apr 2012
- First submitted
- 5 Jan 2010
- Last updated
- 27 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study: The Effect of Cancer Pain Management Protocol on Hospitalized Cancer Patients
- ClinicalTrials.gov ID
- NCT01043068
- Acronym / sponsor ID
- CAPAM-1
- Conditions
- Cancers, Pain
- Keywords
- cancer pain, opioid, guideline
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Collaborators
- Janssen Korea, Ltd., Korea
- Study start
- Jan 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 6 Jan 2010 (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 was to prospectively evaluate the effect of cancer pain management protocol on hospitalized cancer patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pain control | Experimental | Drug: Cancer pain managementInterventions based on published pain guideline. The interventions consisted of the following: (1) nursing pain assessment of current pain, worst pain, pain relief, and acceptability of pain; (2) feedback to guide analgesic prescribing by physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hospitalized patient with the somatic and/or visceral pain having an untreated intensity greater than 3 on a 10 cm visual analog scale (VAS; 0 = no pain, 10 = unbearable pain)over the week prior to enrollment
- A minimum age of 18 years
Key exclusion criteria (8 listed)
- Opioid intolerance
- No longer treatment for their underlying disease.
- Intracerebral primary or metastatic lesion
- Impaired sensory or cognitive function
- Pregnant or lactating woman
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 |
|---|---|---|
| Cancer pain managementInterventions based on published pain guideline. The interventions consisted of the following: (1) nursing pain assessment of current pain, worst pain, pain relief, and acceptability of pain; (2) feedback to guide analgesic prescribing by physician. | Drug | Pain control |
Primary outcome
Reduction in pain scores
Time frame: Jan 2010 - October 2010
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 27 Apr 2012.
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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.
Dae Hyun Kim, Prof principal investigator
National Cancer Center, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cancer pain management in people with Cancers, Pain, run by National Cancer Center, Korea at 1 site in South 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 2 inclusion and 8 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 27 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Reduction in pain scores (time frame: Jan 2010 - October 2010). 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 27 Apr 2012.