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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaires completion | Other | |||
| Clinical Pain Assessments | Other |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Time zero equals baseline up to after at least 4 weeks of observation (Visit 2) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Up to 180 patients diagnosed with bone metastasis suffering from pain will be enrolled into the study to have up to approximately 140 completers
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| Name | Affiliation | Role |
|---|---|---|
| Alvaro Pereira | Tools4Patient | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Bordet | Brussels | 1000 | Belgium | |||
| Cliniques Universitaires Saint Luc |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cancer-Induced Bone Pain (CIBP) | Cancer patients with bone metastasis suffering from pain |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cancer-Induced Bone Pain (CIBP) | Cancer patients with bone metastasis suffering from pain |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Only the patients completing the study per protocol were analyzed. APS was available for 47 patients amongst the per protocol completers. | Posted | Mean | Standard Deviation | units on a scale | Time zero equals baseline up to after at least 4 weeks of observation (Visit 2) |
|
Not applicable: observational study (no safety measurements)
Not applicable: observational study (no safety measurements)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cancer-Induced Bone Pain (CIBP) | cancer patients with bone metastasis suffering from pain |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Alvarez | Tools4Patient | +32 71 14 | 02 00 | stephanie.alvarez@tools4patient.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 10, 2017 | Apr 23, 2019 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Nov 24, 2014 | Apr 23, 2019 | Prot_001.pdf |
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Use of potentially available archived tumor tissue block and/or aliquot of standard safety laboratory blood sample for genotyping purposes are optional in this study for patients recruited in Belgium.
This optional research is not proposed to any patient recruited in France
| 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: 3. 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? | 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 | 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 | 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. | 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 | 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: 9. Pain has interfered in the last 24 hours with
| Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2) |
| Brussels |
| 1200 |
| Belgium |
| Universitair Ziekenhuis Antwerpen | Edegem | 2650 | Belgium |
| ATC, CHU Sart Tilman | Liège | 4000 | Belgium |
| Hôpital A. Mignot | Le Chesnay | 78157 | France |
| Centre Oscar Lambert | Lille | 59000 | France |
| Hôpital La Timone | Marseille | 13385 | France |
| Institut Curie | Paris | 75005 | France |
| years |
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| Sex: Female, Male | Only subjects completing the study per protocol were analysed | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
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| Secondary | 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) | Only the patients completing the study per protocol were analyzed. WPS was available for 46 patients amongst the per protocol completers. | Posted | Mean | Standard Deviation | units on a scale | Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2) |
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|
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| Secondary | 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: 3. 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? | Only the patients completing the study per protocol were analyzed. APS was available for 51 patients amongst the per protocol completers. | Posted | Mean | Standard Deviation | score on a scale | Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2) |
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| Secondary | 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 | Only the patients completing the study per protocol were analyzed. IGAC was available for 48 patients amongst the per protocol completers. | Posted | Mean | Standard Deviation | units on a scale | Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2) |
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| Secondary | 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 | Only the patients completing the study per protocol were analyzed. PGAC was available for 50 patients amongst the per protocol completers. | Posted | Mean | Standard Deviation | units on a scale | Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2) |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Number of symptoms | Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2) |
|
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|
| Secondary | 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 | Posted | Mean | Standard Deviation | score on a scale | Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2) |
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|
| Secondary | 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: 9. Pain has interfered in the last 24 hours with
| Posted | Mean | Standard Deviation | score on a scale | Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2) |
|
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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