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

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 Overview

• Status: Completed
• Conditions: Bone Metastasis
• Intervention / Treatment: Other: Questionnaires completion; Other: Clinical Pain Assessments

• Study Type: Observational
• Enrollment (Actual): 74

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Cliniques universitaires Saint Luc
  • Brussels, Belgium, 1000
    • Institut Bordet
  • Edegem, Belgium, 2650
    • Universitair Ziekenhuis Antwerpen
  • Liège, Belgium, 4000
    • ATC, CHU Sart Tilman
• France
  • Le Chesnay, France, 78157
    • Hôpital A. Mignot
  • Lille, France, 59000
    • Centre Oscar Lambert
  • Marseille, France, 13385
    • Hôpital La Timone
  • Paris, France, 75005
    • Institut Curie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)	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; General Activity?; Mood?; Walking Abililty?; Work?; Relations with other people?; Sleep?; Enjoyment of life?	Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)

Collaborators and Investigators

• Sponsor: Tools4Patient
• Investigators: Study Director: Alvaro Pereira, Tools4Patient

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): April 28, 2017
• Study Completion (Actual): April 28, 2017

Study Registration Dates

• First Submitted: April 20, 2016
• First Submitted That Met QC Criteria: May 12, 2016
• First Posted (Estimate): May 17, 2016

Study Record Updates

• Last Update Posted (Actual): August 19, 2019
• Last Update Submitted That Met QC Criteria: July 12, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplasms by Site; Hematologic Diseases; Musculoskeletal Diseases; Neoplastic Processes; Bone Diseases; Neoplasm Metastasis; Bone Neoplasms; Bone Marrow Diseases
• Other Study ID Numbers: T2001-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO