Breast CancerREBECCA-QoLNCT06002022
Evaluation of Improvements in Patient-reported Quality of Life
A study testing REBECCA system (smartwatch + mobile app use) in people with Breast Cancer and Quality of Life, run by Fundación para la Investigación del Hospital Clínico de Valencia at 1 site in Spain.
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer, Quality of Life, Physical Activity
- What is being tested?
- REBECCA system (smartwatch + mobile app use)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients that are not willing to sign an informed consent form
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínico Universitario de Valencia
Valencia, 46010
Tania Fleitas, MD, PhD, +34 616315091, tfleitask@gmail.com
About this study
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
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
Read the 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.
- Conditions
- Breast Cancer, Quality of Life, Physical Activity, Sleep Quality, Stress, Pain
- Being tested
- REBECCA system (smartwatch + mobile app use)
- Medical subject headings
- Breast Neoplasms, Motor Activity, Sleep Initiation and Maintenance Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REBECCA system (smartwatch + mobile app use)Device
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
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment | No intervention | Patients in the control arm will be treated as usual after the first-line breast cancer treatment. Specifically, in Valencia, this process entails biannual medical evaluation control visits for the first port-treatment year at the Oncology Department, including standardised blood examinations. On top of that, patients of this group will be offered 3 supportive consultation sessions, over the phone, with generic advice on desired lifestyle choices (physical activity, dietary habits, sleep habits and social mobility) that will be helpful for managing the ongoing treatment |
| Standard treatment + REBECCA | Experimental | Patients will be trained in the use of the complementary monitoring modules of the REBECCA mobile and online monitoring platform, which will be used longitudinally, facilitating the collection of real world data within the REBECCA framework. Their supervising health personnel will be given access to the REBECCA patient dashboard, that provides in-depth information about their lifestyle, as well as continuous REBECCA measurements for their online behaviour and self- or companion-reported measures of emotional state and quality of life.
Unlike those in the "Standard care" study-arm, 3 phone-based consultation sessions in the first 12 months of treatment visits will be scheduled based on system-predicted eminent life functionality and emotional state deteriorations (and potential decrease in treatment compliance), targeting the just-in-time patient support, aiming at improving treatment acceptance and efficacy Receives: Device: REBECCA system (smartwatch + mobile app use) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 18 months follow up since enrolment with a monthly measurement
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)
Measured: 18 months follow up since enrolment with a monthly measurement
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)
Measured: 18 months follow up since enrolment with a monthly measurement
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)
Measured: 18 months follow up since enrolment with a monthly measurement
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)
Measured: 18 months follow up since enrolment with a monthly measurement
Secondary outcomes (2)
Weight
Weight measurement (kg) as part of the anthropometric examination
Measured: 18 months follow up since enrolment
Height
Height measurement (cm) as part of the anthropometric examination
Measured: 18 months follow up since enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Jan 2024
- Primary completion28 Jul 2025
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Control arm: Patients will be treated as usual after the first-line breast cancer treatment. Specifically, this process entails biannual medical evaluation control visits for the first port-treatment year at the Oncology Department, including standardised blood examinations. Experimental arm: Additionally, patients will be trained in the use of the REBECCA mobile and online monitoring platform, which will be used longitudinally, with the collection of real-world data within the REBECCA framework. Their supervising health personnel will be given access to the REBECCA patient dashboard, which provides in-depth information about their lifestyle, as well as continuous REBECCA measurements for their online behaviour and self- or companion-reported measures of emotional state and quality of life.
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06002022
- Sponsor's protocol ID
- 2022/005-QoL
- Acronym
- REBECCA-QoL
- Status last verified
- Aug 2025
- First submitted
- 3 Feb 2023
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06002022
- Acronym / sponsor ID
- REBECCA-QoL / 2022/005-QoL
- Conditions
- Breast Cancer, Quality of Life, Physical Activity, Sleep Quality, Stress, Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de ValenciaUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 28 Jul 2025 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Control arm: Patients will be treated as usual after the first-line breast cancer treatment. Specifically, this process entails biannual medical evaluation control visits for the first port-treatment year at the Oncology Department, including standardised blood examinations. Experimental arm: Additionally, patients will be trained in the use of the REBECCA mobile and online monitoring platform, which will be used longitudinally, with the collection of real-world data within the REBECCA framework. Their supervising health personnel will be given access to the REBECCA patient dashboard, which provides in-depth information about their lifestyle, as well as continuous REBECCA measurements for their online behaviour and self- or companion-reported measures of emotional state and quality of life.
| Arm | Type | Receives |
|---|---|---|
| Standard treatment | No intervention | –Patients in the control arm will be treated as usual after the first-line breast cancer treatment. Specifically, in Valencia, this process entails biannual medical evaluation control visits for the first port-treatment year at the Oncology Department, including standardised blood examinations. On top of that, patients of this group will be offered 3 supportive consultation sessions, over the phone, with generic advice on desired lifestyle choices (physical activity, dietary habits, sleep habits and social mobility) that will be helpful for managing the ongoing treatment |
| Standard treatment + REBECCA | Experimental | Device: REBECCA system (smartwatch + mobile app use)Patients will be trained in the use of the complementary monitoring modules of the REBECCA mobile and online monitoring platform, which will be used longitudinally, facilitating the collection of real world data within the REBECCA framework. Their supervising health personnel will be given access to the REBECCA patient dashboard, that provides in-depth information about their lifestyle, as well as continuous REBECCA measurements for their online behaviour and self- or companion-reported measures of emotional state and quality of life. Unlike those in the "Standard care" study-arm, 3 phone-based consultation sessions in the first 12 months of treatment visits will be scheduled based on system-predicted eminent life functionality and emotional state deteriorations (and potential decrease in treatment compliance), targeting the just-in-time patient support, aiming at improving treatment acceptance and efficacy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients that are not willing to sign an informed consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Standard treatment + REBECCA |
Primary outcome
Resting quality
Time frame: 18 months follow up since enrolment with a monthly measurement
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)
Stress level
Time frame: 18 months follow up since enrolment with a monthly measurement
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)
Stress level related to illness
Time frame: 18 months follow up since enrolment with a monthly measurement
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)
Pain level of the last 24 hours
Time frame: 18 months follow up since enrolment with a monthly measurement
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)
Tiredness level of the last 24 hours
Time frame: 18 months follow up since enrolment with a monthly measurement
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)
2 secondary outcomes
Weight
Time frame: 18 months follow up since enrolment
Height
Time frame: 18 months follow up since enrolment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REBECCA system (smartwatch + mobile app use) in people with Breast Cancer and Quality of Life, run by Fundación para la Investigación del Hospital Clínico de Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting quality (time frame: 18 months follow up since enrolment with a monthly measurement). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.