Recruiting
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 breast cancer patients (BCP), as a result of flexible treatment planning supported by REBECCA-collected real-world data, in comparison with standard care
ClinicalTrials.gov IDNCT06002022
PhaseNA
Enrollment110
SponsorFundación para la Investigación del Hospital Clínico de Valencia
Age18 Years
SexFEMALE
Conditions studied
Breast Cancer, Quality of Life, Physical Activity, Sleep Quality, Stress, Pain
About this study
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
Interventions
- 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
Primary outcomes
- Resting quality (18 months follow up since enrolment with a monthly measurement)
- Stress level (18 months follow up since enrolment with a monthly measurement)
- Stress level related to illness (18 months follow up since enrolment with a monthly measurement)
- Pain level of the last 24 hours (18 months follow up since enrolment with a monthly measurement)
- Tiredness level of the last 24 hours (18 months follow up since enrolment with a monthly measurement)
Eligibility information
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
Study locations
- Hospital Clínico Universitario de Valencia, Valencia, 46010 Spain
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.