Bone MetastasisNCT02774213
A Study to Collect Data About Analgesia in Patients With Bone Metastasis
An observational study of Bone Metastasis, run by Tools4Patient at 8 sites in 2 countries.
Trial summary
Up to 180 patients with bone metastasis and requiring analgesic treatment will be followed during 4 to 10 weeks. All patients will continue to receive their cancer therapeutic treatments and be treated for pain relief exactly as they would normally be by the Investigator based on their needs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Metastasis
- What is being tested?
- Questionnaires completion and Clinical Pain Assessments
- How many people
- 74 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Jul 2014to 28 Apr 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Up to 180 patients diagnosed with bone metastasis suffering from pain will be enrolled into the study to have up to approximately 140 completers
Who may be able to join
- Patients with bone tumors or bone metastasis from any primary cancer origin that is supported by histological or radiological investigations.
- Patients having been or being treated for their bone metastasis and/or their primary cancer.
- Patients who require analgesic treatment for unsatisfactory pain relief.
- Patients will be required to score at least 4 on the WAPS 11-point NRS during the week preceding enrollment.
- Patients undergoing or not a radiotherapy program provided visit procedures are performed before any radiotherapy sessions if scheduled on the same visit days.
- Are men or women of at least 18 years of age.
- Are reliable and willing to make themselves available for the entire duration of the study and are willing to follow study procedures.
- Have given written informed consent approved by the relevant Ethics Committee governing the study site.
Who cannot join
- Patients having had a major surgery within 28 days prior to signing Informed Consent Document or planning to have a major surgery during the study.
- Patients having a life expectancy < 3 months according to Investigator judgment.
- Patients having poor nutritional status or whose condition is unstable or who could be rapidly deteriorating in such a way that they would not be able to complete the study.
- Patients with a current or recent history unrelated to their cancer condition, as determined by the Investigator, of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease which would interfere with the patient's participation in the study.
- Patients having a Karnofsky performance status below 70% or WHO score (Eastern Cooperative Oncology Group (ECOG)/Zubrod score) above 1.
- Are Investigator site staffs directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
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- Any other relevant medical disorder likely to interfere with the trial or represent a risk for the patient.
- Patients under legal protection, according to the country law.
- Patients currently enrolled in a clinical trial involving use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study, or in an exclusion period according to the national law.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Belgium4 sites
Institut Bordet
Brussels, 1000
Cliniques Universitaires Saint Luc
Brussels, 1200
Universitair Ziekenhuis Antwerpen
Edegem, 2650
ATC, CHU Sart Tilman
Liège, 4000
France4 sites
Hôpital A. Mignot
Le Chesnay, 78157
Centre Oscar Lambert
Lille, 59000
Hôpital La Timone
Marseille, 13385
Institut Curie
Paris, 75005
About this study
Official title: An Observational Study to Collect Data Characterizing Analgesia in Patients Suffering From Bone Metastasis Induced Pain
Up to 180 patients with bone metastasis and requiring analgesic treatment will be followed during 4 to 10 weeks. All patients will continue to receive their cancer therapeutic treatments and be treated for pain relief exactly as they would normally be by the Investigator based on their needs. During their regular visits to the Investigator, patients will complete questionnaires and Clinical Pain Assessments.
- Conditions
- Bone Metastasis
- Being tested
- Questionnaires completion, Clinical Pain Assessments
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires completionOther
Clinical Pain AssessmentsOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's Change From Baseline of Pain Severity, as Measured by the Weekly Means of the Daily Average Pain Scores (APS)
11-point Numeric Rating Scale from 0 to 10 with 0 meaning no pain and 10 pain as bad as you can imagine; baseline measure was the Weekly Average Pain Score (WAPS), over the week first visit (the last 7 days); end of study measure was the mean of the APS of the last 7 days prior to last visit (Visit 2)
Measured: Time zero equals baseline up to after at least 4 weeks of observation (Visit 2)
Secondary outcomes (7)
Patient's Change From Baseline of Pain Severity, as Measured by the Weekly Means of the Daily Worst Pain Score (WPS)
11-point Numeric Rating Scale from 0 to 10 with 0 meaning no pain and 10 pain as bad as you can imagine; baseline measure was was the mean of the WPS of the first 7 days after first visit (Visit 1); end of study measure was the mean of the WPS of the last 7 days prior to last visit (Visit 2)
Measured: Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)
Patient's Change From Baseline of Pain Severity as Measured by the Brief Pain Inventory (BPI)
The pain severity score of BPI is an arithmetic average of the 4 severity scores reported on an 11- point NRS going from 0 (no pain) to 10 (pain as bad as you can imagine).
The BPI severity questions are:
- Your pain at its worst in the last 24 hours? 4. Your pain at its least in the last 24 hours? 5. Your pain on the average? 6. How much pain you have right now?
Measured: Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)
Patient's Change From Baseline of Investigator Global Assessment of Changes (IGAC)
Investigator subjective evaluation of patient condition using an 11-point NRS with 0 meaning best and 10 worst
Measured: Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)
Patient's Change From Baseline of Patient Global Assessment of Changes (PGAC)
Patient subjective evaluation of patient condition using an 11-point NRS with 0 meaning best and 10 worst
Measured: Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)
Patient's Change From Baseline of Pain Intensity Measured After Clinical Pain Assessments (CPAs)
Number of symptoms measured after Clinical Pain Assessments (CPAs), 0 no symptom to 3 all the three symptoms : Hyperalgesia, Hypoesthesia, and Sensory loss.
Measured: Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)
Patient's Change From Baseline of Quality-of-Life Questionnaire in 30 Questions (QLQ-C30).
Pain scale of the Quality-of-Life Questionnaire in 30 questions (QLQ-C30); 2 items in the Pain scale ranging each from 1 to 4 (high score for a symptom scale / item represents a high level of symptomatology / problems); Pain score is sum of of the 2 items
Measured: Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)
Patient's Change From Baseline of Pain Interference as Measured by the Brief Pain Inventory (BPI)
The pain interference score of BPI is an arithmetic average of the 7 interference scores reported on an 11-point NRS going from 0 (does not interfere) to 10 (completely interferes)
The BPI interference questions are:
- Pain has interfered in the last 24 hours with
- General Activity?
- Mood?
- Walking Abililty?
- Work?
- Relations with other people?
- Sleep?
- Enjoyment of life?
Measured: Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study startJul 2014
- Primary completion28 Apr 2017
- Study completion28 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bone MetastasisStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tools4Patient
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alvaro Pereira, Study director, Tools4Patient
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02774213
- Sponsor's protocol ID
- T2001-01
- Status last verified
- Jul 2019
- First submitted
- 20 Apr 2016
- Last updated
- 19 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Collect Data Characterizing Analgesia in Patients Suffering From Bone Metastasis Induced Pain
- ClinicalTrials.gov ID
- NCT02774213
- Acronym / sponsor ID
- T2001-01
- Conditions
- Bone Metastasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Tools4PatientUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- 28 Apr 2017 (actual)
- Study completion
- 28 Apr 2017 (actual)
- First posted
- 17 May 2016 (estimated)
- Results
- Posted 19 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Up to 180 patients with bone metastasis and requiring analgesic treatment will be followed during 4 to 10 weeks. All patients will continue to receive their cancer therapeutic treatments and be treated for pain relief exactly as they would normally be by the Investigator based on their needs. During their regular visits to the Investigator, patients will complete questionnaires and Clinical Pain Assessments.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 180 patients diagnosed with bone metastasis suffering from pain will be enrolled into the study to have up to approximately 140 completers
Key inclusion criteria (8 listed)
- Patients with bone tumors or bone metastasis from any primary cancer origin that is supported by histological or radiological investigations.
- Patients having been or being treated for their bone metastasis and/or their primary cancer.
- Patients who require analgesic treatment for unsatisfactory pain relief.
- Patients will be required to score at least 4 on the WAPS 11-point NRS during the week preceding enrollment.
- Patients undergoing or not a radiotherapy program provided visit procedures are performed before any radiotherapy sessions if scheduled on the same visit days.
Key exclusion criteria (9 listed)
- Patients having had a major surgery within 28 days prior to signing Informed Consent Document or planning to have a major surgery during the study.
- Patients having a life expectancy < 3 months according to Investigator judgment.
- Patients having poor nutritional status or whose condition is unstable or who could be rapidly deteriorating in such a way that they would not be able to complete the study.
- Patients with a current or recent history unrelated to their cancer condition, as determined by the Investigator, of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease which would interfere with the patient's participation in the study.
- Patients having a Karnofsky performance status below 70% or WHO score (Eastern Cooperative Oncology Group (ECOG)/Zubrod score) above 1.
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 |
|---|---|---|
| Questionnaires completion | Other | – |
| Clinical Pain Assessments | Other | – |
Primary outcome
Patient's Change From Baseline of Pain Severity, as Measured by the Weekly Means of the Daily Average Pain Scores (APS)
Time frame: Time zero equals baseline up to after at least 4 weeks of observation (Visit 2)
11-point Numeric Rating Scale from 0 to 10 with 0 meaning no pain and 10 pain as bad as you can imagine; baseline measure was the Weekly Average Pain Score (WAPS), over the week first visit (the last 7 days); end of study measure was the mean of the APS of the last 7 days prior to last visit (Visit 2)
7 secondary outcomes
Patient's Change From Baseline of Pain Severity, as Measured by the Weekly Means of the Daily Worst Pain Score (WPS)
Time frame: Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)
Patient's Change From Baseline of Pain Severity as Measured by the Brief Pain Inventory (BPI)
Time frame: Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)
Patient's Change From Baseline of Investigator Global Assessment of Changes (IGAC)
Time frame: Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)
Patient's Change From Baseline of Patient Global Assessment of Changes (PGAC)
Time frame: Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)
Patient's Change From Baseline of Pain Intensity Measured After Clinical Pain Assessments (CPAs)
Time frame: Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)
Patient's Change From Baseline of Quality-of-Life Questionnaire in 30 Questions (QLQ-C30).
Time frame: Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)
Patient's Change From Baseline of Pain Interference as Measured by the Brief Pain Inventory (BPI)
Time frame: Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Alvaro Pereira study director
Tools4Patient
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Metastasis, run by Tools4Patient at 8 sites in 2 countries.
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 9 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 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Belgium, France. 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?
Yes. Results are posted in the registry (first posted 19 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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's Change From Baseline of Pain Severity, as Measured by the Weekly Means of the Daily Average Pain Scores (APS) (time frame: Time zero equals baseline up to after at least 4 weeks of observation (Visit 2)). 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 Aug 2019.