Back to resultsEvaluation of Medical Practice in the Management of Bone Metastases After Injectable Bone Antiresorptive Treatment, and Its Influence on Quality of Life (PRISM)
Primary Purpose
Tumor With Bone Metastasis
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
quality of life questionaries
intravenous or oral bone antiresorptive treatments
Sponsored by
About this trial
This is an interventional other trial for Tumor With Bone Metastasis
Eligibility 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
Sites / Locations
- Centre Hospitalier Régional Universitaire de BesançonRecruiting
- Hôpital Nord Franche-ComtéRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
quality of life questionaries
Arm Description
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)
Outcomes
Primary Outcome Measures
evaluation of 4 targeted dimensions of the EORTC-QLQ-BM22 quality of life questionarie
evaluation of 4 parameters: painful sites characteristics of pain, functional impairment, psychosocial aspect
Secondary Outcome Measures
Full Information
NCT ID
NCT02839291
First Posted
July 18, 2016
Last Updated
May 10, 2022
Sponsor
Centre Hospitalier Universitaire de Besancon
1. Study Identification
Unique Protocol Identification Number
NCT02839291
Brief Title
Evaluation of Medical Practice in the Management of Bone Metastases After Injectable Bone Antiresorptive Treatment, and Its Influence on Quality of Life
Acronym
PRISM
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 Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 2016 (undefined)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tumor With Bone Metastasis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
154 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
quality of life questionaries
Arm Type
Experimental
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
quality of life questionaries
Intervention Type
Drug
Intervention Name(s)
intravenous or oral bone antiresorptive treatments
Primary Outcome Measure Information:
Title
evaluation of 4 targeted dimensions of the EORTC-QLQ-BM22 quality of life questionarie
Description
evaluation of 4 parameters: painful sites characteristics of pain, functional impairment, psychosocial aspect
Time Frame
to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefano KIM, Dr
Email
stefanokim@me.com
Facility Information:
Facility Name
Centre Hospitalier Régional Universitaire de Besançon
City
Besançon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefano KIM, Dr
Email
stefanokim@me.com
First Name & Middle Initial & Last Name & Degree
Stefano KIM, Dr
Facility Name
Hôpital Nord Franche-Comté
City
Montbéliard
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefano KIM, Dr
Email
stefanokim@me.com
First Name & Middle Initial & Last Name & Degree
Stefano KIM, Dr
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Medical Practice in the Management of Bone Metastases After Injectable Bone Antiresorptive Treatment, and Its Influence on Quality of Life
We'll reach out to this number within 24 hrs