xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06002022</url>
    </required_header>
    <id_info>
      <org_study_id>2022/005-QoL</org_study_id>
      <nct_id>NCT06002022</nct_id>
    </id_info>
    <brief_title>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</brief_title>
    <acronym>REBECCA-QoL</acronym>
    <official_title>REBECCA-QoL: 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</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fundación para la Investigación del Hospital Clínico de Valencia</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fundación para la Investigación del Hospital Clínico de Valencia</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Local intervention trial for the evaluation of improvements in patient-reported Quality of&#xD;
        Life and treatment satisfaction, in breast cancer patients (BCP), as a result of flexible&#xD;
        treatment planning supported by REBECCA-collected real-world data, in comparison with&#xD;
        standard care&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Local intervention trial which will evaluate the potential of using real-world patient&#xD;
        measurements collected by the REBECCA system for improving the patient-reported&#xD;
        quality-of-life, through just-in-time support consultations, during the first 12 months after&#xD;
        radiology and/or chemotherapy treatment. The effects of the REBECCA-assisted treatment on&#xD;
        QoL, in relation to baseline, will be compared against standard&#xD;
  &#xD;
        The use of REBECCA-collected patient information by BCP-supervising health professionals&#xD;
        (based on the continuous REBECCA real-world measurements), aims to estimate to which extent&#xD;
        it:&#xD;
  &#xD;
        - Improves the quality of the provided treatment at 12 months, resulting in an improved QoL,&#xD;
        in comparison with standard treatment practice&#xD;
  &#xD;
        It will also evaluate that:&#xD;
  &#xD;
          -  The observed improvements will persist long-term, at least till the point of the&#xD;
             18-month follow-up evaluation&#xD;
  &#xD;
          -  The observed QoL improvements will be associated with REBECCA's Functional Life Index&#xD;
             improvements, as evaluated through the continuous REBECCA real world measurements. This&#xD;
             will act as an assessment of the RWD use for safer and more effective post-treatment&#xD;
             management of interventions with first line chemo/radiotherapies in breast cancer.&#xD;
  &#xD;
          -  The observed QoL improvements will be associated with REBECCA's PROM Index improvements,&#xD;
             as evaluated through the continuous REBECCA real world measurements.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">March 28, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_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.&#xD;
  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.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Resting quality</measure>
      <time_frame>18 months follow up since enrolment with a monthly measurement</time_frame>
      <description>Emotional state deterioration from QoL questionnaires of the last 24 hours prior to the measurement.&#xD;
  Scale scored from 1-5 (1 not rested, 5 very rested)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Stress level</measure>
      <time_frame>18 months follow up since enrolment with a monthly measurement</time_frame>
      <description>Emotional state deterioration from QoL questionnaires of the last 24 hours prior to the measurement.&#xD;
  Scale scored from 1-5 (1 not stressed, 5 very stressed)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Stress level related to illness</measure>
      <time_frame>18 months follow up since enrolment with a monthly measurement</time_frame>
      <description>Emotional state deterioration from QoL questionnaires of the last 24 hours prior to the measurement.&#xD;
  Scale scored from 1-5 (1 not stressed, 5 very stressed)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pain level of the last 24 hours</measure>
      <time_frame>18 months follow up since enrolment with a monthly measurement</time_frame>
      <description>Emotional state deterioration from QoL questionnaires of the last 24 hours prior to the measurement.&#xD;
  Scale scored from 1-5 (1 not bad, 5 very bad)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Tiredness level of the last 24 hours</measure>
      <time_frame>18 months follow up since enrolment with a monthly measurement</time_frame>
      <description>Emotional state deterioration from QoL questionnaires of the last 24 hours prior to the measurement.&#xD;
  Scale scored from 1-5 (1 not tired, 5 very tired)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Weight</measure>
      <time_frame>18 months follow up since enrolment</time_frame>
      <description>Weight measurement (kg) as part of the anthropometric examination</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Height</measure>
      <time_frame>18 months follow up since enrolment</time_frame>
      <description>Height measurement (cm) as part of the anthropometric examination</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">110</enrollment>
    <condition>Breast Cancer</condition>
    <condition>Quality of Life</condition>
    <condition>Physical Activity</condition>
    <condition>Sleep Quality</condition>
    <condition>Stress</condition>
    <condition>Pain</condition>
    <arm_group>
      <arm_group_label>Standard treatment</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>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.&#xD;
  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</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard treatment + REBECCA</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.&#xD;
  Unlike those in the &quot;Standard care&quot; 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</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>REBECCA system (smartwatch + mobile app use)</intervention_name>
      <description>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</description>
      <arm_group_label>Standard treatment + REBECCA</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Before patient registration, written informed consent must be given according to&#xD;
               national and local regulations.&#xD;
  &#xD;
            -  Participants have had histologically proven stage I-III breast cancer undergoing&#xD;
               endocrine treatment (with or without prior chemotherapy) no more than 12 months prior&#xD;
               to randomization.&#xD;
  &#xD;
            -  Be between 18 and 75 years of age.&#xD;
  &#xD;
            -  Have increased life expectancy beyond the initial 3 months post-treatment initiation.&#xD;
  &#xD;
            -  Have the ability to understand protocol, participate in testing and willingness to&#xD;
               sign a written informed consent.&#xD;
  &#xD;
            -  Absence of any psychological, familial, sociological or geographical condition&#xD;
               potentially hampering compliance with the study protocol and follow-up schedule.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients that are not willing to sign an informed consent form&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Hospital Clínico Universitario de Valencia</name>
        <address>
          <city>Valencia</city>
          <zip>46010</zip>
          <country>Spain</country>
        </address>
      </facility>
      <contact>
        <last_name>Cristina Hernando</last_name>
        <phone>+34 689567412</phone>
        <email>c.hernandomelia@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <link>
      <url>http://rebeccaproject.eu/</url>
      <description>Related Info</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>February 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Fundación para la Investigación del Hospital Clínico de Valencia</investigator_affiliation>
      <investigator_full_name>Cristina Hernando</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Breast Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Informed Consent Form</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>January 5, 2022</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/22/NCT06002022/ICF_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06002022
  org study id: 2022/005-QoL
  nct id: NCT06002022
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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:
  
          -  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention 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.
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Resting quality
  time frame: 18 months follow up since enrolment with a monthly measurement
  description: 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)
  measure: Stress level
  time frame: 18 months follow up since enrolment with a monthly measurement
  description: 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)
  measure: Stress level related to illness
  time frame: 18 months follow up since enrolment with a monthly measurement
  description: 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)
  measure: Pain level of the last 24 hours
  time frame: 18 months follow up since enrolment with a monthly measurement
  description: 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)
  measure: Tiredness level of the last 24 hours
  time frame: 18 months follow up since enrolment with a monthly measurement
  description: 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)
  measure: Weight
  time frame: 18 months follow up since enrolment
  description: Weight measurement (kg) as part of the anthropometric examination
  measure: Height
  time frame: 18 months follow up since enrolment
  description: Height measurement (cm) as part of the anthropometric examination
  arm group label: Standard treatment
  arm group type: No Intervention
  description: 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
  arm group label: Standard treatment + REBECCA
  arm group type: Experimental
  description: 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
  intervention type: Device
  intervention name: REBECCA system (smartwatch + mobile app use)
  description: 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
  arm group label: Standard treatment + REBECCA
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  facility: 
  contact: 
  country: Spain
  url: http://rebeccaproject.eu/
  description: Related Info
  responsible party type: Principal Investigator
  investigator affiliation: Fundación para la Investigación del Hospital Clínico de Valencia
  investigator full name: Cristina Hernando
  investigator title: Principal Investigator
  mesh term: Breast Neoplasms
  sharing ipd: Undecided
  provided document: 