NeoplasmsNCT01313234
Educational Intervention Targeting Nurses Attitudes and Knowledge About Cancer-related Pain Management
A study testing Education in people with Neoplasms, run by Blekinge Institute of Technology at 1 site in Sweden.
Trial summary
The purpose of this study is to investigate whether an intervention consisting of the implementation of guidelines about daily systematic pain assessment following a theory based education, targeting cancer-related pain and pain treatment, lead to a significantly positive improvement in RNs knowledge of, and attitudes… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2011to Dec 2011
- Phase
- Interventional
- 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
- Cancer diagnosis
- Aged 18 years and above
- Cognitively intact and able to verbally communicate
- At admission pain intensity >1 on Visual Analogue Scale (VAS)
Who cannot join
- Trauma or planned and/or acute surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Theory Based Educational Intervention Targeting Nurses Attitudes and Knowledge Concerning Cancer-related Pain Management: A Study Protocol of a Quasi-experimental Study Design
The purpose of this study is to investigate whether an intervention consisting of the implementation of guidelines about daily systematic pain assessment following a theory based education, targeting cancer-related pain and pain treatment, lead to a significantly positive improvement in RNs knowledge of, and attitudes towards their pain management. Furthermore will the interventions targeting the RNs influence the admitted patient's perception of their cancer-related pain?
- Conditions
- Neoplasms
- Being tested
- Education
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
Theory based education and systematic daily assessment
| Study group | Role | What they receive |
|---|---|---|
| Education | Experimental | Educational theory based intervention and systematic daily pain assessment Receives: Behavioral: Education |
| Control | No intervention | Control group with care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of the total score of Knowledge and Attitudes Survey Regarding Pain
Nurses attitude and knowledge as measured by a modified version of the instrument: Knowledge and Attitudes Survey Regarding Pain
Measured: Measurement will occur at first session of the educational intervention and 2 and 6 weeks after
Secondary outcomes (1)
Change from Baseline - Brief Pain Inventory, Short Form (BPI-SF)
BPI-SF is a pain-assessment instrument developed for cancer patient. The instrument consists of nine items, and a figure depicting a human body where the patient marks position and type of pain. BPI-SF includes items concerning the degree of pain right now, pain during the last day and pain on average as well as items concerning effect of pain treatment, walking ability, mood, work, relationships and if sleep are affected by pain.
Measured: Measurement will occur at admission of the patient and at discharge from the hospital. Estimated average time period from admission to discharge is 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionJun 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies 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 N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Blekinge Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01313234
- Sponsor's protocol ID
- BFR20100046019
- Status last verified
- Jan 2013
- First submitted
- 5 Mar 2011
- Last updated
- 8 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Gustafsson M, Borglin G. Can a theory-based educational intervention change nurses' knowledge and attitudes concerning cancer pain management? A quasi-experimental design. BMC Health Serv Res. 2013 Aug 19;13:328. doi: 10.1186/1472-6963-13-328.
PubMed 23958335Borglin G, Gustafsson M, Krona H. A theory-based educational intervention targeting nurses' attitudes and knowledge concerning cancer-related pain management: a study protocol of a quasi-experimental design. BMC Health Serv Res. 2011 Sep 23;11:233. doi: 10.1186/1472-6963-11-233.
PubMed 21942991
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Theory Based Educational Intervention Targeting Nurses Attitudes and Knowledge Concerning Cancer-related Pain Management: A Study Protocol of a Quasi-experimental Study Design
- ClinicalTrials.gov ID
- NCT01313234
- Acronym / sponsor ID
- BFR20100046019
- Conditions
- Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Blekinge Institute of TechnologyUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 11 Mar 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 investigate whether an intervention consisting of the implementation of guidelines about daily systematic pain assessment following a theory based education, targeting cancer-related pain and pain treatment, lead to a significantly positive improvement in RNs knowledge of, and attitudes towards their pain management. Furthermore will the interventions targeting the RNs influence the admitted patient's perception of their cancer-related pain?
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education | Experimental | Behavioral: EducationEducational theory based intervention and systematic daily pain assessment |
| Control | No intervention | –Control group with care as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cancer diagnosis
- Aged 18 years and above
- Cognitively intact and able to verbally communicate
- At admission pain intensity >1 on Visual Analogue Scale (VAS)
Key exclusion criteria (1 listed)
- Trauma or planned and/or acute surgery.
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 |
|---|---|---|
| EducationTheory based education and systematic daily assessment | Behavioural | Education |
Primary outcome
Change from baseline of the total score of Knowledge and Attitudes Survey Regarding Pain
Time frame: Measurement will occur at first session of the educational intervention and 2 and 6 weeks after
Nurses attitude and knowledge as measured by a modified version of the instrument: Knowledge and Attitudes Survey Regarding Pain
1 secondary outcome
Change from Baseline - Brief Pain Inventory, Short Form (BPI-SF)
Time frame: Measurement will occur at admission of the patient and at discharge from the hospital. Estimated average time period from admission to discharge is 2 weeks
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 8 Jan 2013.
- Derived from this study: PubMed 23958335Gustafsson M, Borglin G. Can a theory-based educational intervention change nurses' knowledge and attitudes concerning cancer pain management? A quasi-experimental design. BMC Health Serv Res. 2013 Aug 19;13:328. doi: 10.1186/1472-6963-13-328.
- Derived from this study: PubMed 21942991Borglin G, Gustafsson M, Krona H. A theory-based educational intervention targeting nurses' attitudes and knowledge concerning cancer-related pain management: a study protocol of a quasi-experimental design. BMC Health Serv Res. 2011 Sep 23;11:233. doi: 10.1186/1472-6963-11-233.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Neoplasms, run by Blekinge Institute of Technology at 1 site in Sweden.
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 8 Jan 2013. 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 Sweden. 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.
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?
Change from baseline of the total score of Knowledge and Attitudes Survey Regarding Pain (time frame: Measurement will occur at first session of the educational intervention and 2 and 6 weeks after). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01313234, which also lists 2 linked publications.
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 8 Jan 2013.