Evaluation of Improvements in Patient-reported Quality of Life
NCT06002022 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110
Last updated 2025-08-06
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
Conditions
- Breast Cancer
- Quality of Life
- Physical Activity
- Sleep Quality
- Stress
- Pain
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
Sponsors & Collaborators
-
Fundación para la Investigación del Hospital Clínico de Valencia
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-01-01
- Primary Completion
- 2025-07-28
- Completion
- 2025-12-31
Countries
- Spain
Study Locations
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