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

NCT02774213 | Completed Results

• 1 other identifier: T2001-01
• Study Type: observational
• Target: 74
• Locations: 2 countries
• Sites: 8

Brief 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. During their regular visits to the Investigator, patients will complete questionnaires and Clinical Pain Assessments.

Conditions

Bone Metastasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

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

  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 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 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 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 zero equals baseline up to after at least 4 weeks of treatment (Visit 2)

Interventions

Questionnaires completion OTHER

Clinical Pain Assessments OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tools4Patient: lead

Study Sites (8)

Institut Bordet

Brussels, 1000, Belgium

Location

Cliniques Universitaires Saint Luc

Brussels, 1200, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, 2650, Belgium

Location

ATC, CHU Sart Tilman

Liège, 4000, Belgium

Location

Hôpital A. Mignot

Le Chesnay, 78157, France

Location

Centre Oscar Lambert

Lille, 59000, France

Location

Hôpital La Timone

Marseille, 13385, France

Location

Institut Curie

Paris, 75005, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

Results Point of Contact

• Title: Stephanie Alvarez
• Organization: Tools4Patient

stephanie.alvarez@tools4patient.com

+32 71 14

Study Officials

• Alvaro Pereira

  Tools4Patient

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2016
• First Posted: May 17, 2016
• Study Start: July 1, 2014
• Primary Completion: April 28, 2017
• Study Completion: April 28, 2017
• Last Updated: August 19, 2019
• Results First Posted: August 19, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (4); FR (4)