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

Breast Cancer Clinical Trial

— REBECCA-QoL  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06002022
• Other study ID #: 2022/005-QoL
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2023
• Source: Fundación para la Investigación del Hospital Clínico de Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: December 31, 2025
• Est. primary completion date: March 28, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Before patient registration, written informed consent must be given according to national and local regulations.
• Participants have had histologically proven stage I-III breast cancer undergoing endocrine treatment (with or without prior chemotherapy) no more than 12 months prior to randomization.
• Be between 18 and 75 years of age.
• Have increased life expectancy beyond the initial 3 months post-treatment initiation.
• Have the ability to understand protocol, participate in testing and willingness to sign a written informed consent.
• Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

Exclusion Criteria:

• Patients that are not willing to sign an informed consent form

Related Conditions & MeSH terms

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

Intervention

Device:
• REBECCA system (smartwatch + mobile app use)
Patients will be trained in the use of the REBECCA system, which will provide in-depth information about their lifestyle (including physical activity levels, dietary habits, sleep quality and social mobility), as well as of their online behaviour (with outcome indicators of anxiety, PTSD and depression development) and self- or companion-reported measures of emotional state and quality of life. Based on the additional information, exploiting the enhanced monitoring capabilities of the REBECCA system, the supervising clinicians will be given the opportunity to continuously evaluate the progress of the patients, allowing them to schedule up to 3 phone-based consultation sessions in the first 12 months of treatment

Locations

Country	Name	City	State
Spain	Hospital Clínico Universitario de Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Fundación para la Investigación del Hospital Clínico de Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resting quality	Emotional state deterioration from QoL questionnaires of the last 24 hours prior to the measurement.; Scale scored from 1-5 (1 not rested, 5 very rested)	18 months follow up since enrolment with a monthly measurement
Primary	Stress level	Emotional state deterioration from QoL questionnaires of the last 24 hours prior to the measurement.; Scale scored from 1-5 (1 not stressed, 5 very stressed)	18 months follow up since enrolment with a monthly measurement
Primary	Stress level related to illness	Emotional state deterioration from QoL questionnaires of the last 24 hours prior to the measurement.; Scale scored from 1-5 (1 not stressed, 5 very stressed)	18 months follow up since enrolment with a monthly measurement
Primary	Pain level of the last 24 hours	Emotional state deterioration from QoL questionnaires of the last 24 hours prior to the measurement.; Scale scored from 1-5 (1 not bad, 5 very bad)	18 months follow up since enrolment with a monthly measurement
Primary	Tiredness level of the last 24 hours	Emotional state deterioration from QoL questionnaires of the last 24 hours prior to the measurement.; Scale scored from 1-5 (1 not tired, 5 very tired)	18 months follow up since enrolment with a monthly measurement
Secondary	Weight	Weight measurement (kg) as part of the anthropometric examination	18 months follow up since enrolment
Secondary	Height	Height measurement (cm) as part of the anthropometric examination	18 months follow up since enrolment

External Links

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