Clinical trial NCT02774213: A Study to Collect Data About Analgesia in Patients With Bone Metastasis
Official title: An Observational Study to Collect Data Characterizing Analgesia in Patients Suffering From Bone Metastasis Induced Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Metastasis
Lead sponsor: Tools4Patient
Sponsor class: OTHER
First posted: 2016-05-17
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Patient's Change From Baseline of Pain Severity, as Measured by the Weekly Means of the Daily Average Pain Scores (APS)
timeFrame: Time zero equals baseline up to after at least 4 weeks of observation (Visit 2)
Secondary outcomes:
measure: Patient's Change From Baseline of Pain Severity, as Measured by the Weekly Means of the Daily Worst Pain Score (WPS)
timeFrame: Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)
measure: Patient's Change From Baseline of Pain Severity as Measured by the Brief Pain Inventory (BPI)
timeFrame: Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)
measure: Patient's Change From Baseline of Investigator Global Assessment of Changes (IGAC)
timeFrame: Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)
measure: Patient's Change From Baseline of Patient Global Assessment of Changes (PGAC)
timeFrame: Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)
measure: Patient's Change From Baseline of Pain Intensity Measured After Clinical Pain Assessments (CPAs)
timeFrame: Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)
measure: Patient's Change From Baseline of Quality-of-Life Questionnaire in 30 Questions (QLQ-C30).
timeFrame: Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)
measure: Patient's Change From Baseline of Pain Interference as Measured by the Brief Pain Inventory (BPI)
timeFrame: Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Institut Bordet
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint Luc
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Liège
country: Belgium
facility: ATC, CHU Sart Tilman
city: Le Chesnay
country: France
facility: Hôpital A. Mignot
city: Lille
country: France
facility: Centre Oscar Lambert
city: Marseille
country: France
facility: Hôpital La Timone
city: Paris
country: France
facility: Institut Curie
Study officials:
affiliation: Tools4Patient
name: Alvaro Pereira
role: STUDY_DIRECTOR
References: