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

Tools4Patient (Cognivia)

Status: Completed

Conditions: Bone Metastasis

Treatments: Other: Clinical Pain Assessments; Other: Questionnaires completion

Study type: Observational

Funder types: Other

Identifiers

NCT02774213

T2001-01

Details and patient eligibility

About

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.

Enrollment: 74 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design