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/NCT05989477</url>
    </required_header>
    <id_info>
      <org_study_id>20-6232</org_study_id>
      <nct_id>NCT05989477</nct_id>
    </id_info>
    <brief_title>At-home Breast Oncology Care Delivered With E-health Solutions</brief_title>
    <acronym>ABODE</acronym>
    <official_title>At-home Breast Oncology Care Delivered With E-health Solutions The ABODE Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Health Network, Toronto</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Health Network, Toronto</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>
        The COVID-19 pandemic has significantly impacted healthcare service delivery, highlighting&#xD;
        the need for high quality virtual patient care. Our team has developed a multi-dimensional&#xD;
        remote eHealth solution for newly diagnosed breast cancer patients and their practitioners to&#xD;
        use during the diagnostic and follow-up period. The ABODE study involved development of a&#xD;
        Breast Cancer Treatment Application (app) which will facilitate virtual consultations,&#xD;
        deliver patient education material, and collect patient reported outcome measures (PROMs).&#xD;
        Using a randomized controlled trial design, the team will evaluate a variety of outcomes for&#xD;
        breast cancer patients who will use the app throughout their diagnosis and treatment period.&#xD;
  &#xD;
        Primary Objective: To compare changes in patient activation (assessed by PAM-13) over 1 year&#xD;
        among newly diagnosed breast cancer patients between those using the app and those receiving&#xD;
        standard care.&#xD;
  &#xD;
        Secondary Objectives:&#xD;
  &#xD;
          1. Compare additional PROMs between the standard care and intervention groups&#xD;
  &#xD;
          2. Describe health service outcomes among app users&#xD;
  &#xD;
          3. Explore end-user experience of using the app&#xD;
  &#xD;
          4. Measure activity levels using wearable devices&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        To measure the effect of the app compared to the standard care approach, the study team will&#xD;
        conduct a randomized controlled trial of 200 newly diagnosed breast cancer patients seen at a&#xD;
        tertiary care cancer centre in Ontario, Canada. The intervention group (n=100) will receive&#xD;
        access to the app in addition to standard care for 13 months following their diagnosis. The&#xD;
        control group (n=100) will have standard care. Both arms will be provided with a Fitbit&#xD;
        wearable device.&#xD;
  &#xD;
        The PAM-13 scale assesses patient activation, defined as the knowledge and confidence a&#xD;
        patient has in self- management of one's health. Research team will test whether use of the&#xD;
        app improves PAM-13 scores at the 12-month follow-up.&#xD;
  &#xD;
        Additionally, secondary outcomes will be assessed with data from additional patient-reported&#xD;
        outcome measures (PROMs), chart review, hospital administrative databases, and Fitbits. All&#xD;
        participants will complete PROMs at baseline, 6- and 12- months post diagnosis via REDCap&#xD;
        survey links sent through email. The intervention group will have access to the app for 13&#xD;
        months following randomization.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 22, 2023</start_date>
    <completion_date type="Anticipated">June 22, 2026</completion_date>
    <primary_completion_date type="Anticipated">April 22, 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>The intervention group (n=100) will receive access to the app in addition to standard care for 13 months following their diagnosis. The control group (n=100) will have standard care.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>After randomization patients will be told what experimental arm they are in.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Primary Objective</measure>
      <time_frame>At baseline, 6 months and 12 months after enrollment</time_frame>
      <description>To compare changes in patient activation (assessed by Patient Activation Measure -13) over 1 year among newly diagnosed breast cancer patients between those using the Breast Cancer Treatment Application (BCTA) and those receiving standard care.&#xD;
  Difference in Patient Activation Measure (PAM) scores between pre/post intervention. PAM includes 13 questions, each with 4 response options, summed on a 0-100 scale, with higher scores indicating higher activation level.&#xD;
  Patient activation is defined as the knowledge, skills, and confidence a person has in managing their health and care. Studies have shown that higher patient activation is associated with improved health related quality of life (HRQoL) and lower health care utilization.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>PROM 1: Impact of Events Scale - Revised (IES-R)</measure>
      <time_frame>At baseline, 6 and 12 months after diagnosis</time_frame>
      <description>Number of participants with PTSD symptoms, such as distress in regards to their Breast Cancer diagnosis and treatment as assessed by IES-R.&#xD;
  Items are rated on a 5-point scale ranging from 0 (&quot;not at all&quot;) to 4 (&quot;extremely&quot;). The IES-R yields a total score (ranging from 0 to 88); higher scores mean worse symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PROM 2: Generalized Anxiety Disorder (GAD-7)</measure>
      <time_frame>At baseline, 6 and 12 months after diagnosis</time_frame>
      <description>Number of participant with generalized anxiety around their breast cancer diagnosis and treatment assessed by GAD-7.&#xD;
  The GAD-7 is a 7-item scale used to measure or assess the severity of generalized anxiety disorder based on symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PROM 3: European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire (EORTC QLQ-C30)</measure>
      <time_frame>At baseline, 6-months and 12-months post-diagnosis</time_frame>
      <description>Number of participants with changes in their physical, psychological and social functions during and after their diagnosis and surgery, assessed by the EORTC QLQ-C30.&#xD;
  The EORTC Core Questionnaire (QLQ-C30) includes six clearly distinguishable functioning scales that have been thoroughly tested and validated on an international level and that are available in 110 different language versions. About the functional scale and the global health status, the higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PROM 4: European Organisation for Research and Treatment of Cancer - Breast Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23)</measure>
      <time_frame>At baseline, 6-months and 12-months after enrollment</time_frame>
      <description>Number of participants with changes in their quality of life after their breast cancer diagnosis and treatment journey assessed by the EORTC QLQ-BR23.&#xD;
  The survey includes functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Scores average and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PROM 5: Self-Identification Survey</measure>
      <time_frame>At baseline</time_frame>
      <description>Number of participants and their reported identities assessed by the self-identification survey.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PROM 6: European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire INFO 25 (EORTC QLQ-INFO 25).</measure>
      <time_frame>9-months post-diagnosis</time_frame>
      <description>Number of participants and their satisfaction with information provided about treatment received assessed by the EORTC QLQ-INFO25.&#xD;
  The provisional 25-item information questionnaire is Questions used 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Scores average and transformed to 0-100 scale. High score for functional scale=higher satisfaction with provided treatment information.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PROM 7: The Health Information Questionnaire (heiQ)</measure>
      <time_frame>At baseline, 9 months post-diagnosis</time_frame>
      <description>Number of participants and how comfortable they are with the patient educational programs provided throughout the patient's treatment journey, assessed by the heiQ at the beginning and 9 months post diagnosis.&#xD;
  heiQ is a validated, self-reported instrument with 8 domains to comprehensively evaluate patient education program and self-management intervention. Each domain score ranges from 1 to 4; a higher score indicates better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PROM 8: Clinical Evaluation Questionnaire - INS (CEQ-INS)</measure>
      <time_frame>6 and 12 months post-diagnosis</time_frame>
      <description>Number of participants and their experience of cancer care in teams of their receipt of useful and relevant information about cancer, assistance with service navigation, and support from their care team examined with the CEQ-INS half way and end of the study.&#xD;
  CEQ-INS is a self-reported instrument with questions used 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Higher scores correlate with higher patient satisfaction with the information and support provided from their care team.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PROM 9: Other Health App Questionnaire (OHA)</measure>
      <time_frame>6 and 12 months post-diagnosis</time_frame>
      <description>Number of participants and how frequently they use other e-health applications assessed by the OHA.&#xD;
  The OHA is a self reported questionnaire with an array question (yes, no, unsure) regarding the participants involvement with other e-health applications.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PROM 10: The Duke Activity Status Index (DASI)</measure>
      <time_frame>Baseline</time_frame>
      <description>Number of participants and their functional capacity evaluated by the DASI at the beginning of the study.&#xD;
  The Duke Activity Status Index (DASI) is a 12-item questionnaire that utilized self-reported physical work capacity to estimate peak metabolic equivalents (METs) and has been shown to be a valid measurement of functional capacity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PROM 11:The Multidimensional Impact of Cancer Risk Assessment (MICRA)</measure>
      <time_frame>1 Week Post Genetic Test Results via BCTA</time_frame>
      <description>A 25-item tool use to assess participants and the specific impact of result disclosure after genetic testing. The assessment administers 4 point Likert-type questions (never=0 to often=5) regarding how individuals feel after being told their genetic test results.&#xD;
  Distress subscale = Items 1-4, 7 &amp; 8; Uncertainty subscale = Items 9-12, 14-17 &amp; 20; Positive experiences subscale (reverse scored) = Items 5, 6, 18 &amp; 19. Subscales are scored by summing circled numbers</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PROM 12: The Knowgene</measure>
      <time_frame>1 Week Post Genetic Test Results via BCTA</time_frame>
      <description>The number of participants and their general cancer genetic knowledge after cancer genetic counseling and multigene panel testing.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PROM 13: Breast Cancer Treatment Application Review Survey (BCTA)</measure>
      <time_frame>12-months Post-Enrollment</time_frame>
      <description>Patient satisfaction with the app will be measured by utilizing the Breast Cancer Treatment Application Review Survey. The survey will be administered to participants using the application at the 12-month mark, to better understand any barriers to using the app and which aspects were most useful to patients. The 10 item assessment uses 5-point Likert-type questions (strongly disagree to strongly agree) to assess their experience on the application.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PROM 14: Functional Assessment Of Cancer Therapy-Endocrine Subscale (FACT-ES) Score</measure>
      <time_frame>2 to 3 Months Post Start of Endocrine Treatment via Breast Cancer Treatment App</time_frame>
      <description>Investigators will measure relative changes in adverse symptom burden using the Functional Assessment Of Cancer Therapy-Endocrine Subscale (FACT-ES) questionnaire. The FACT-ES is a 46-item questionnaire asking participants to report how much they have been impacted by a variety of symptoms on a 5-point scale where 0 = not at all and 4 = very much. Total raw scores range from 0 to 184, with higher scores indicating greater impact from symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PROM 15: System-Usability Score (SUS)</measure>
      <time_frame>12-months Post-Enrollment</time_frame>
      <description>Usability will be assessed using the System Usability Scale (SUS). We wil collect the input of breast cancer patients to the SUS questions, using in-app surveys and will calculate the SUS score. We will assess overall satisfaction with the app by asking users to provide an answer to the question &quot;How likely are you to recommend this product to a friend&quot; on a scale of 0-10.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Patient Engagement</condition>
    <condition>Patient Activation</condition>
    <condition>Patient Reported Outcome Measures</condition>
    <arm_group>
      <arm_group_label>Control Arm</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The control arm will receive standard treatment.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Interventional Arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Individuals within the intervention will receive standard care and access to the Breast Cancer Treatment Application (BCTA) for 13 months.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>At-home Breast Oncology care Delivered with E-health solutions - ABODE</intervention_name>
      <description>The development and implementation of the Breast Cancer Treatment Application (BCTA) will facilitate a secure approach to virtual care for Breast Cancer patients, provide patient specific treatment education and facilitate evaluation of Patient Reported Outcome Measures.</description>
      <arm_group_label>Interventional Arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Females (assigned female at birth)*&#xD;
  &#xD;
            -  Diagnosed with first, primary invasive BC&#xD;
  &#xD;
            -  Must have surgery as their first step in treatment pathway&#xD;
  &#xD;
            -  Age≥18&#xD;
  &#xD;
            -  Access to an electronic device with connection to the internet&#xD;
  &#xD;
            -  A valid email address&#xD;
  &#xD;
            -  Can communicate in English *Since BC risk is sex-related and based on physiological&#xD;
               values, our inclusion criteria are based on sex (not gender)&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            -  Males (assigned male at birth), as BC surgical treatment options and experiences are&#xD;
               different&#xD;
  &#xD;
            -  Diagnosed with non-operable breast cancer&#xD;
  &#xD;
            -  Stage 4/metastatic (whether determined at diagnosis or during surgery)&#xD;
  &#xD;
            -  Those with hearing or visual challenges&#xD;
  &#xD;
            -  Neo-adjuvant chemotherapy&#xD;
  &#xD;
            -  Should not be enrolled in any other UHN study using an e-Health application&#xD;
  &#xD;
            -  Breast cancer surgery is scheduled for less 5 business days after enrollment&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Tulin Cil, MD, MEd</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Health Network, Toronto</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Tulin Cil, MD, MEd</last_name>
      <phone>416-946-4507</phone>
      <phone_ext>3984</phone_ext>
      <email>tulin.cil@uhn.ca</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Emma Reel, MSW</last_name>
      <phone>647-202-1028</phone>
      <email>emma.reel@uhn.ca</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Tulin Cil</name>
        <address>
          <city>Toronto</city>
          <state>Ontario</state>
          <zip>M5G2M9</zip>
          <country>Canada</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Tulin Cil, MD, MEd</last_name>
        <phone>4169464507</phone>
        <email>tulin.cil@uhn.ca</email>
      </contact>
      <contact_backup>
        <last_name>Emma Reel, MSW</last_name>
        <phone>6472021028</phone>
        <email>emma.reel@uhn.ca</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University Health Network, Toronto</investigator_affiliation>
      <investigator_full_name>Tulin Cil</investigator_full_name>
      <investigator_title>Breast Surgeon</investigator_title>
    </responsible_party>
    <keyword>e-Health</keyword>
    <keyword>m-Health</keyword>
    <keyword>Mobile Application</keyword>
    <keyword>Psychosocial Oncology</keyword>
    <keyword>Survivorship</keyword>
    <keyword>Breast Cancer</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05989477
  org study id: 20-6232
  nct id: NCT05989477
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The COVID-19 pandemic has significantly impacted healthcare service delivery, highlighting
        the need for high quality virtual patient care. Our team has developed a multi-dimensional
        remote eHealth solution for newly diagnosed breast cancer patients and their practitioners to
        use during the diagnostic and follow-up period. The ABODE study involved development of a
        Breast Cancer Treatment Application (app) which will facilitate virtual consultations,
        deliver patient education material, and collect patient reported outcome measures (PROMs).
        Using a randomized controlled trial design, the team will evaluate a variety of outcomes for
        breast cancer patients who will use the app throughout their diagnosis and treatment period.
  
        Primary Objective: To compare changes in patient activation (assessed by PAM-13) over 1 year
        among newly diagnosed breast cancer patients between those using the app and those receiving
        standard care.
  
        Secondary Objectives:
  
          1. Compare additional PROMs between the standard care and intervention groups
  
          2. Describe health service outcomes among app users
  
          3. Explore end-user experience of using the app
  
          4. Measure activity levels using wearable devices
  To measure the effect of the app compared to the standard care approach, the study team will
        conduct a randomized controlled trial of 200 newly diagnosed breast cancer patients seen at a
        tertiary care cancer centre in Ontario, Canada. The intervention group (n=100) will receive
        access to the app in addition to standard care for 13 months following their diagnosis. The
        control group (n=100) will have standard care. Both arms will be provided with a Fitbit
        wearable device.
  
        The PAM-13 scale assesses patient activation, defined as the knowledge and confidence a
        patient has in self- management of one's health. Research team will test whether use of the
        app improves PAM-13 scores at the 12-month follow-up.
  
        Additionally, secondary outcomes will be assessed with data from additional patient-reported
        outcome measures (PROMs), chart review, hospital administrative databases, and Fitbits. All
        participants will complete PROMs at baseline, 6- and 12- months post diagnosis via REDCap
        survey links sent through email. The intervention group will have access to the app for 13
        months following randomization.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The intervention group (n=100) will receive access to the app in addition to standard care for 13 months following their diagnosis. The control group (n=100) will have standard care.
  primary purpose: Supportive Care
  masking: None (Open Label)
  masking description: After randomization patients will be told what experimental arm they are in.
  measure: Primary Objective
  time frame: At baseline, 6 months and 12 months after enrollment
  description: To compare changes in patient activation (assessed by Patient Activation Measure -13) over 1 year among newly diagnosed breast cancer patients between those using the Breast Cancer Treatment Application (BCTA) and those receiving standard care.
  Difference in Patient Activation Measure (PAM) scores between pre/post intervention. PAM includes 13 questions, each with 4 response options, summed on a 0-100 scale, with higher scores indicating higher activation level.
  Patient activation is defined as the knowledge, skills, and confidence a person has in managing their health and care. Studies have shown that higher patient activation is associated with improved health related quality of life (HRQoL) and lower health care utilization.
  measure: PROM 1: Impact of Events Scale - Revised (IES-R)
  time frame: At baseline, 6 and 12 months after diagnosis
  description: Number of participants with PTSD symptoms, such as distress in regards to their Breast Cancer diagnosis and treatment as assessed by IES-R.
  Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The IES-R yields a total score (ranging from 0 to 88); higher scores mean worse symptoms.
  measure: PROM 2: Generalized Anxiety Disorder (GAD-7)
  time frame: At baseline, 6 and 12 months after diagnosis
  description: Number of participant with generalized anxiety around their breast cancer diagnosis and treatment assessed by GAD-7.
  The GAD-7 is a 7-item scale used to measure or assess the severity of generalized anxiety disorder based on symptoms.
  measure: PROM 3: European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire (EORTC QLQ-C30)
  time frame: At baseline, 6-months and 12-months post-diagnosis
  description: Number of participants with changes in their physical, psychological and social functions during and after their diagnosis and surgery, assessed by the EORTC QLQ-C30.
  The EORTC Core Questionnaire (QLQ-C30) includes six clearly distinguishable functioning scales that have been thoroughly tested and validated on an international level and that are available in 110 different language versions. About the functional scale and the global health status, the higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life.
  measure: PROM 4: European Organisation for Research and Treatment of Cancer - Breast Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23)
  time frame: At baseline, 6-months and 12-months after enrollment
  description: Number of participants with changes in their quality of life after their breast cancer diagnosis and treatment journey assessed by the EORTC QLQ-BR23.
  The survey includes functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Scores average and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems.
  measure: PROM 5: Self-Identification Survey
  time frame: At baseline
  description: Number of participants and their reported identities assessed by the self-identification survey.
  measure: PROM 6: European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire INFO 25 (EORTC QLQ-INFO 25).
  time frame: 9-months post-diagnosis
  description: Number of participants and their satisfaction with information provided about treatment received assessed by the EORTC QLQ-INFO25.
  The provisional 25-item information questionnaire is Questions used 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Scores average and transformed to 0-100 scale. High score for functional scale=higher satisfaction with provided treatment information.
  measure: PROM 7: The Health Information Questionnaire (heiQ)
  time frame: At baseline, 9 months post-diagnosis
  description: Number of participants and how comfortable they are with the patient educational programs provided throughout the patient's treatment journey, assessed by the heiQ at the beginning and 9 months post diagnosis.
  heiQ is a validated, self-reported instrument with 8 domains to comprehensively evaluate patient education program and self-management intervention. Each domain score ranges from 1 to 4; a higher score indicates better outcome.
  measure: PROM 8: Clinical Evaluation Questionnaire - INS (CEQ-INS)
  time frame: 6 and 12 months post-diagnosis
  description: Number of participants and their experience of cancer care in teams of their receipt of useful and relevant information about cancer, assistance with service navigation, and support from their care team examined with the CEQ-INS half way and end of the study.
  CEQ-INS is a self-reported instrument with questions used 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Higher scores correlate with higher patient satisfaction with the information and support provided from their care team.
  measure: PROM 9: Other Health App Questionnaire (OHA)
  time frame: 6 and 12 months post-diagnosis
  description: Number of participants and how frequently they use other e-health applications assessed by the OHA.
  The OHA is a self reported questionnaire with an array question (yes, no, unsure) regarding the participants involvement with other e-health applications.
  measure: PROM 10: The Duke Activity Status Index (DASI)
  time frame: Baseline
  description: Number of participants and their functional capacity evaluated by the DASI at the beginning of the study.
  The Duke Activity Status Index (DASI) is a 12-item questionnaire that utilized self-reported physical work capacity to estimate peak metabolic equivalents (METs) and has been shown to be a valid measurement of functional capacity.
  measure: PROM 11:The Multidimensional Impact of Cancer Risk Assessment (MICRA)
  time frame: 1 Week Post Genetic Test Results via BCTA
  description: A 25-item tool use to assess participants and the specific impact of result disclosure after genetic testing. The assessment administers 4 point Likert-type questions (never=0 to often=5) regarding how individuals feel after being told their genetic test results.
  Distress subscale = Items 1-4, 7 & 8; Uncertainty subscale = Items 9-12, 14-17 & 20; Positive experiences subscale (reverse scored) = Items 5, 6, 18 & 19. Subscales are scored by summing circled numbers
  measure: PROM 12: The Knowgene
  time frame: 1 Week Post Genetic Test Results via BCTA
  description: The number of participants and their general cancer genetic knowledge after cancer genetic counseling and multigene panel testing.
  measure: PROM 13: Breast Cancer Treatment Application Review Survey (BCTA)
  time frame: 12-months Post-Enrollment
  description: Patient satisfaction with the app will be measured by utilizing the Breast Cancer Treatment Application Review Survey. The survey will be administered to participants using the application at the 12-month mark, to better understand any barriers to using the app and which aspects were most useful to patients. The 10 item assessment uses 5-point Likert-type questions (strongly disagree to strongly agree) to assess their experience on the application.
  measure: PROM 14: Functional Assessment Of Cancer Therapy-Endocrine Subscale (FACT-ES) Score
  time frame: 2 to 3 Months Post Start of Endocrine Treatment via Breast Cancer Treatment App
  description: Investigators will measure relative changes in adverse symptom burden using the Functional Assessment Of Cancer Therapy-Endocrine Subscale (FACT-ES) questionnaire. The FACT-ES is a 46-item questionnaire asking participants to report how much they have been impacted by a variety of symptoms on a 5-point scale where 0 = not at all and 4 = very much. Total raw scores range from 0 to 184, with higher scores indicating greater impact from symptoms.
  measure: PROM 15: System-Usability Score (SUS)
  time frame: 12-months Post-Enrollment
  description: Usability will be assessed using the System Usability Scale (SUS). We wil collect the input of breast cancer patients to the SUS questions, using in-app surveys and will calculate the SUS score. We will assess overall satisfaction with the app by asking users to provide an answer to the question "How likely are you to recommend this product to a friend" on a scale of 0-10.
  arm group label: Control Arm
  arm group type: No Intervention
  description: The control arm will receive standard treatment.
  arm group label: Interventional Arm
  arm group type: Experimental
  description: Individuals within the intervention will receive standard care and access to the Breast Cancer Treatment Application (BCTA) for 13 months.
  intervention type: Other
  intervention name: At-home Breast Oncology care Delivered with E-health solutions - ABODE
  description: The development and implementation of the Breast Cancer Treatment Application (BCTA) will facilitate a secure approach to virtual care for Breast Cancer patients, provide patient specific treatment education and facilitate evaluation of Patient Reported Outcome Measures.
  arm group label: Interventional Arm
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Tulin Cil, MD, MEd
  role: Principal Investigator
  affiliation: University Health Network, Toronto
  last name: Tulin Cil, MD, MEd
  phone: 416-946-4507
  phone ext: 3984
  email: tulin.cil@uhn.ca
  last name: Emma Reel, MSW
  phone: 647-202-1028
  email: emma.reel@uhn.ca
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Canada
  responsible party type: Principal Investigator
  investigator affiliation: University Health Network, Toronto
  investigator full name: Tulin Cil
  investigator title: Breast Surgeon
  mesh term: Neoplasms
  sharing ipd: No