Evaluation of Improvements in Patient-reported Quality of Life — REBECCA-QoL  

Breast Cancer Clinical Trial

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

Clinical Trial 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

Clinical Trial 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 and/or 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 REBECCA's 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 chemo/radiotherapies in breast cancer.

• The observed QoL improvements will be associated with REBECCA's PROM Index improvements, as evaluated through the continuous REBECCA real world measurements. ;

Related Conditions & MeSH terms

• Breast Cancer
• Pain
• Physical Activity
• Quality of Life
• Sleep Quality
• Stress

• NCT number: NCT06002022
• Study type: Interventional
• Source: Fundación para la Investigación del Hospital Clínico de Valencia
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Completion date: December 31, 2025