RecruitingNot ApplicableNCT06002022

Evaluation of Improvements in Patient-reported Quality of Life

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

Sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Enrollment

110 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Pain Quality of Life Sleep Quality Stress Physical Activity

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

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Inclusion Criteria6

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 Criteria1

Patients that are not willing to sign an informed consent form

Interventions

DEVICEREBECCA 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