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 — REBECCA-QoL

Breast Cancer Clinical Trial

Official title:
REBECCA-QoL: 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

Status Not yet 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06002022
Study type	Interventional
Source	Fundación para la Investigación del Hospital Clínico de Valencia
Contact
Status	Not yet recruiting
Phase	N/A
Start date	September 1, 2023
Completion date	December 31, 2025

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.