Bone MetastasesPhase 3PEEPNCT01358539
Palliation: the Effect of Education on Pain
A Phase 3 study testing Pain education in people with Bone Metastases, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Rationale: Although radiotherapy is an effective palliative treatment for patients with painful bone metastases with over 70% responders, pain intensity is not always sufficiently controlled. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bone Metastases
- What is being tested?
- Pain education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 354 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2010to Apr 2016
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- uncomplicated painful bone metastases
- primary malignancy is a solid tumour
- pain intensity on a numeric rating scale of 5 or higher
- indication for short-term radiotherapy
- able to fill out Dutch questionnaires
- able to follow instructions
- informed consent provided
Who cannot join
- Hematological malignancy
- Long-term schedule radiotherapy
- Life expectancy shorter than three months
- Karnofsky Performance Score of 40 or less
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Education for Patients With Painful Bone Metastases Undergoing Palliative Radiotherapy: Reducing Pain by Increasing Patient's Knowledge and Self-management
Rationale: Although radiotherapy is an effective palliative treatment for patients with painful bone metastases with over 70% responders, pain intensity is not always sufficiently controlled. Recent analyses from the randomized Dutch Bone Metastasis Study on 1157 patients show that during weekly follow up, 35% of the patients remain above a pain intensity level of 4 on a numeric rating scale (range 0-10) despite pain medication. According to the WHO criteria, a pain intensity of 5 or higher prompts treatment. As advised in the CBO guideline 'Pijn bij Kanker' educating patients can improve patient empowerment and thereby pain control. However, the effect of a nurse-led education of patients undergoing palliative radiotherapy for painful bone metastases has not been investigated yet.
Objective: This project investigates whether nurse-led pain education in addition to standard care results in better control of pain in patients referred for palliative radiotherapy.
Read more
Study design: A national multicenter phase 3 study (n=450).
Study population: Patients with painful bone metastases referred for short schedule radiotherapy.
Intervention: Patients will be randomized between standard care or standard care with the Pain Education Program, a nurse-led pain education. The pain Education Program will be provided on the same day the radiotherapeutic treatment will start. The nurse will first assess the knowledge of a patient based on a structured interview. Thereafter, lacunas will be taught using the 'Pijninstructie Programma' (Pain Education Program). In addition, nurses will telephone patients at regular intervals during follow-up to monitor their needs.
Main study parameters/endpoints: The primary outcome of this randomized multicenter study is a decrement of the number of patients whose worst pain intensity remains above 4 at any time during the 12 weeks of follow up with regard to the control group. The secondary outcome is improvement of quality of life.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: All patients will fill out the Brief Pain Inventory, the EORTC QLQ-C15-PAL and the EORTC QLQ-BM22 at baseline and, thereafter, weekly for 12 weeks after randomization.
- Conditions
- Bone Metastases
- Being tested
- Pain education
- Keywords
- palliation, pain education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain educationBehavioural
Patients receiving pain education
| Study group | Role | What they receive |
|---|---|---|
| Pain education | Experimental | Patients receiving pain education Receives: Behavioral: Pain education |
| No Pain education | No intervention | Control group, patients receiving no pain education |
What is being measured
The primary outcome is the main question the study is designed to answer.
a decrement of the number of patients whose worst pain intensity remains above 4
The primary outcome of this randomized multicenter study is a decrement of the number of patients whose worst pain intensity remains above 4 at any time during the 12 weeks of follow up with regard to the control group.
Measured: 12 weeks
Secondary outcomes (1)
improvement of quality of life
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2011 (estimated)
- Study startSep 2010
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone MetastasesStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 354 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Kankerbestrijding
- Responsible party
- Sponsor
- Investigators
- A KL Reyners, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01358539
- Sponsor's protocol ID
- ZonMW 11510007
- Acronym
- PEEP
- Status last verified
- Apr 2024
- First submitted
- 19 May 2011
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Education for Patients With Painful Bone Metastases Undergoing Palliative Radiotherapy: Reducing Pain by Increasing Patient's Knowledge and Self-management
- ClinicalTrials.gov ID
- NCT01358539
- Acronym / sponsor ID
- PEEP / ZonMW 11510007
- Conditions
- Bone Metastases
- Keywords
- palliation, pain education
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 354 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Kankerbestrijding
- Study start
- Sep 2010
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 23 May 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.
Rationale: Although radiotherapy is an effective palliative treatment for patients with painful bone metastases with over 70% responders, pain intensity is not always sufficiently controlled. Recent analyses from the randomized Dutch Bone Metastasis Study on 1157 patients show that during weekly follow up, 35% of the patients remain above a pain intensity level of 4 on a numeric rating scale (range 0-10) despite pain medication. According to the WHO criteria, a pain intensity of 5 or higher prompts treatment. As advised in the CBO guideline 'Pijn bij Kanker' educating patients can improve patient empowerment and thereby pain control. However, the effect of a nurse-led education of patients undergoing palliative radiotherapy for painful bone metastases has not been investigated yet.
Objective: This project investigates whether nurse-led pain education in addition to standard care results in better control of pain in patients referred for palliative radiotherapy.
Study design: A national multicenter phase 3 study (n=450).
Study population: Patients with painful bone metastases referred for short schedule radiotherapy.
Intervention: Patients will be randomized between standard care or standard care with the Pain Education Program, a nurse-led pain education. The pain Education Program will be provided on the same day the radiotherapeutic treatment will start. The nurse will first assess the knowledge of a patient based on a structured interview. Thereafter, lacunas will be taught using the 'Pijninstructie Programma' (Pain Education Program). In addition, nurses will telephone patients at regular intervals during follow-up to monitor their needs.
Main study parameters/endpoints: The primary outcome of this randomized multicenter study is a decrement of the number of patients whose worst pain intensity remains above 4 at any time during the 12 weeks of follow up with regard to the control group. The secondary outcome is improvement of quality of life.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: All patients will fill out the Brief Pain Inventory, the EORTC QLQ-C15-PAL and the EORTC QLQ-BM22 at baseline and, thereafter, weekly for 12 weeks after randomization.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pain education | Experimental | Behavioral: Pain educationPatients receiving pain education |
| No Pain education | No intervention | –Control group, patients receiving no pain education |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years or older
- uncomplicated painful bone metastases
- primary malignancy is a solid tumour
- pain intensity on a numeric rating scale of 5 or higher
- indication for short-term radiotherapy
Key exclusion criteria (4 listed)
- Hematological malignancy
- Long-term schedule radiotherapy
- Life expectancy shorter than three months
- Karnofsky Performance Score of 40 or less
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 |
|---|---|---|
| Pain educationPatients receiving pain education | Behavioural | Pain education |
Primary outcome
a decrement of the number of patients whose worst pain intensity remains above 4
Time frame: 12 weeks
The primary outcome of this randomized multicenter study is a decrement of the number of patients whose worst pain intensity remains above 4 at any time during the 12 weeks of follow up with regard to the control group.
1 secondary outcome
improvement of quality of life
Time frame: 12 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 19 Apr 2024.
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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.
A KL Reyners, MD, PhD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pain education in people with Bone Metastases, run by University Medical Center Groningen at 1 site in Netherlands.
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 8 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 19 Apr 2024. 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 Netherlands. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
a decrement of the number of patients whose worst pain intensity remains above 4 (time frame: 12 weeks). 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 19 Apr 2024.