Neoplasms

Symptoms and General Pathology

All Conditions

Musculoskeletal Diseases

Blood and Lymph Conditions

Neoplasm Metastasis

Pain

Bone Neoplasms

Bone Marrow Diseases

Neoplastic Processes

Bone Diseases

Hematologic Diseases

Questionnaires completion

Clinical Pain Assessments

Alvaro Pereira

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.

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

A Study to Collect Data About Analgesia in Patients With Bone Metastasis

An Observational Study to Collect Data Characterizing Analgesia in Patients Suffering From Bone Metastasis Induced Pain

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)

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)

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?

Investigator subjective evaluation of patient condition using an 11-point NRS with 0 meaning best and 10 worst

Patient subjective evaluation of patient condition using an 11-point NRS with 0 meaning best and 10 worst

Number of symptoms measured after Clinical Pain Assessments (CPAs), 0 no symptom to 3 all the three symptoms : Hyperalgesia, Hypoesthesia, and Sensory loss.

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

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

1. General Activity?
2. Mood?
3. Walking Abililty?
4. Work?
5. Relations with other people?
6. Sleep?
7. Enjoyment of life?

Tools4Patient

Not applicable: observational study (no safety measurements)

cancer patients with bone metastasis suffering from pain

Cancer-Induced Bone Pain (CIBP)

Cancer patients with bone metastasis suffering from pain

Age, Continuous

Only subjects completing the study per protocol were analysed

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Stephanie Alvarez

Only the patients completing the study per protocol were analyzed. APS was available for 47 patients amongst the per protocol completers.

Patient's Change From Baseline of Pain Severity, as Measured by the Weekly Means of the Daily Average Pain Scores (APS)

Only the patients completing the study per protocol were analyzed. WPS was available for 46 patients amongst the per protocol completers.

Patient's Change From Baseline of Pain Severity, as Measured by the Weekly Means of the Daily Worst Pain Score (WPS)

Only the patients completing the study per protocol were analyzed. APS was available for 51 patients amongst the per protocol completers.

Patient's Change From Baseline of Pain Severity as Measured by the Brief Pain Inventory (BPI)

Only the patients completing the study per protocol were analyzed. IGAC was available for 48 patients amongst the per protocol completers.

Patient's Change From Baseline of Investigator Global Assessment of Changes (IGAC)

Only the patients completing the study per protocol were analyzed. PGAC was available for 50 patients amongst the per protocol completers.

Spots Global Cancer Trial Database for clinical pain assessments