ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Medical Practice in the Management of Bone Metastases After Injectable Bone Antiresorptive Treatment, and Its Influence on Quality of Life (PRISM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02839291
Recruitment Status : Recruiting
First Posted : July 20, 2016
Last Update Posted : July 21, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Brief Summary:
To evaluate the current medical practice and its influence on health-related quality of life, in patients who are treated with injectable bone antiresorptive drugs (biphosphonates or denosumab) for at least one year.

Condition or disease Intervention/treatment Phase
Tumor With Bone Metastasis Other: quality of life questionaries Drug: intravenous or oral bone antiresorptive treatments Not Applicable

Detailed Description:

This protocol will evaluate the pursuit of injectable bone antiresorptive treatments or their switch to oral biphosphonates, or treatment stop, in the contexte of medical practice.

The primary end-point is the health-related quality of life (QoL). Secondary endpoints are safety, overall survial, the impact of toxicities of the treatment on QoL, and the description of supportive care.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 154 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Evaluation of Medical Practice in the Management of Bone Metastases After Injectable Bone Antiresorptive Treatment, and Its Influence on Quality of Life
Study Start Date : May 2016
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : May 2021

Arm Intervention/treatment
Experimental: quality of life questionaries
Patients should complete 3 quality of life questionaries (EORTC-QLQ C30 ; EORTC QLQ-BM22 and Euroqol EQ-5D) at many time points : at inclusion, every 3 months and at the end of study visit (2 years after inclusion)
Other: quality of life questionaries
Drug: intravenous or oral bone antiresorptive treatments



Primary Outcome Measures :
  1. evaluation of 4 targeted dimensions of the EORTC-QLQ-BM22 quality of life questionarie [ Time Frame: to 6 months ]
    evaluation of 4 parameters: painful sites characteristics of pain, functional impairment, psychosocial aspect



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with histologically proven tumor with bone metastasis, single or multiple (with or without metastasis extra-osseous)
  • Patients treated with injectable bone antiresorptive therapy for 12 months or more
  • Signed written informed consent

Exclusion Criteria:

  • patient with any medical or psychiatric condition or disease which would make the patient inappropriate to complete quality of life questionaries
  • patient under guardianship, curator or under the protection of justice, pregnant or breast-feeding women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02839291


Contacts
Contact: Stefano KIM, Dr stefanokim@me.com

Locations
France
Centre Hospitalier Régional Universitaire de Besançon Recruiting
Besançon, France
Contact: Stefano KIM, Dr       stefanokim@me.com   
Principal Investigator: Stefano KIM, Dr         
Hôpital Nord Franche-Comté Recruiting
Montbéliard, France
Contact: Stefano KIM, Dr       stefanokim@me.com   
Principal Investigator: Stefano KIM, Dr         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon

Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02839291     History of Changes
Other Study ID Numbers: P/2015/279
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: July 21, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Neoplasm Metastasis
Bone Neoplasms
Bone Marrow Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases