Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06002022
Status:
RECRUITING
Last Update Posted:
2024-05-20
First Post:
2023-02-03
Brief Title:
Evaluation of Improvements in Patient-reported Quality of Life
Sponsor:
Cristina Hernando
Organization:
Fundación para la Investigación del Hospital Clínico de Valencia
Study Overview
Official Title:
Local Intervention Trial for the Evaluation of Improvements in Patient-reported Quality of Life and Treatment Satisfaction in BCP as a Result of Flexible Treatment Planning Supported by REBECCA-collected RWD
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REBECCA-QoL
Brief Summary:
Local intervention trial for the evaluation of improvements in patient-reported Quality of Life and treatment satisfaction in breast cancer patients BCP as a result of flexible treatment planning supported by REBECCA-collected real-world data in comparison with standard care
Detailed Description:
Local intervention trial which will evaluate the potential of using real-world patient measurements collected by the REBECCA system for improving the patient-reported quality-of-life through just-in-time support consultations during the first 12 months after radiology andor chemotherapy treatment The effects of the REBECCA-assisted treatment on QoL in relation to baseline will be compared against standard
The use of REBECCA-collected patient information by BCP-supervising health professionals based on the continuous REBECCA real-world measurements aims to estimate to which extent it
- Improves the quality of the provided treatment at 12 months resulting in an improved QoL in comparison with standard treatment practice
It will also evaluate that
The observed improvements will persist long-term at least till the point of the 18-month follow-up evaluation
The observed QoL improvements will be associated with REBECCAs Functional Life Index improvements as evaluated through the continuous REBECCA real world measurements This will act as an assessment of the RWD use for safer and more effective post-treatment management of interventions with first line chemoradiotherapies in breast cancer
The observed QoL improvements will be associated with REBECCAs PROM Index improvements as evaluated through the continuous REBECCA real world measurements
The use of REBECCA-collected patient information by BCP-supervising health professionals based on the continuous REBECCA real-world measurements aims to estimate to which extent it
- Improves the quality of the provided treatment at 12 months resulting in an improved QoL in comparison with standard treatment practice
It will also evaluate that
The observed improvements will persist long-term at least till the point of the 18-month follow-up evaluation
The observed QoL improvements will be associated with REBECCAs Functional Life Index improvements as evaluated through the continuous REBECCA real world measurements This will act as an assessment of the RWD use for safer and more effective post-treatment management of interventions with first line chemoradiotherapies in breast cancer
The observed QoL improvements will be associated with REBECCAs PROM Index improvements as evaluated through the continuous REBECCA real world measurements
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None