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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
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) | 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) | 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) | 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) | 18 months follow up since enrolment with a monthly measurement |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Weight measurement (kg) as part of the anthropometric examination | 18 months follow up since enrolment |
| Height | Height measurement (cm) as part of the anthropometric examination |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnico Universitario de Valencia | Recruiting | Valencia | 46010 | Spain |
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| Label | URL |
|---|---|
| Related Info | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 5, 2022 | Feb 24, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009043 | Motor Activity |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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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.
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|
| 18 months follow up since enrolment |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001519 | Behavior |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |