Evaluation of Improvements in Patient-reported Quality of Life
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: REBECCA system (smartwatch + mobile app use).
- Who it may be relevant to
- Registry conditions: Breast Cancer, Quality of Life, Physical Activity, Sleep Quality. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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
Detailed 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.
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 sy
Primary outcome measures
- Resting quality [Time frame: 18 months follow up since enrolment with a monthly measurement]
- Stress level [Time frame: 18 months follow up since enrolment with a monthly measurement]
- Stress level related to illness [Time frame: 18 months follow up since enrolment with a monthly measurement]
- Pain level of the last 24 hours [Time frame: 18 months follow up since enrolment with a monthly measurement]
- Tiredness level of the last 24 hours [Time frame: 18 months follow up since enrolment with a monthly measurement]
Secondary outcome measures (2)
- Weight [Time frame: 18 months follow up since enrolment]
- Height [Time frame: 18 months follow up since enrolment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Spain · 1 center
- Hospital Clínico Universitario de Valencia — Valencia
Identifiers
NCT: NCT06002022 · 2022/005-QoL