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/NCT06019442</url>
    </required_header>
    <id_info>
      <org_study_id>LR22-071-91112</org_study_id>
      <nct_id>NCT06019442</nct_id>
    </id_info>
    <brief_title>An Electronic Brief Alcohol Intervention for Women Attending a Breast Screening Service (Health4Her)</brief_title>
    <official_title>An Electronic Brief Intervention to Reduce Alcohol Consumption Intentions, Improve Alcohol Literacy, and Reduce Harmful Use Among Women Attending a Breast Screening Service: a Randomised Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Turning Point</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Monash University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Eastern Health</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>BreastScreen Victoria</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Lifepool</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Shades of Pink</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Turning Point</source>
    <oversight_info>
      <has_dmc>No</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>
        Alcohol is a major modifiable risk factor for female breast cancer; yet, awareness of this&#xD;
        risk remains surprisingly low and is not systematically addressed in healthcare settings.&#xD;
        This study aim to test the effectiveness of a co-designed, automated brief alcohol&#xD;
        intervention (Health4Her-Automated) in reducing women's drinking intentions, improving&#xD;
        alcohol literacy, and reducing consumption.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Alcohol is a major modifiable risk factor for female breast cancer, even in very low amounts.&#xD;
        In Australia, alcohol consumption accounts for 6.6 per cent of cases in post-menopausal&#xD;
        women, and 18 per cent of breast cancer deaths. Yet, awareness of this risk remains low and&#xD;
        is not systematically addressed in healthcare settings. Embedding a brief alcohol&#xD;
        intervention within lifestyle information offered to all women attending breast screening&#xD;
        provides the opportunity to address harmful drinking in a discrete, non-judgmental way, to&#xD;
        prevent alcohol-attributable breast cancer among this at-risk population.&#xD;
  &#xD;
        Brief alcohol interventions are short, single-session programs typically offered in general&#xD;
        practice settings to gather information on a person's alcohol consumption and, in a non&#xD;
        confrontational way, provide strategies and motivate change to reduce consumption and related&#xD;
        risk of harm. An automated brief alcohol intervention, self-completed on a device such as an&#xD;
        iPad, is a low-cost, labour- and time-efficient approach that overcomes many of the issues of&#xD;
        providing intervention within busy healthcare environments.&#xD;
  &#xD;
        Building on the previous pilot trial of a prototype brief e-health intervention (which&#xD;
        included alcohol-related questions asked by a researcher, and an animation viewed on an iPad&#xD;
        that was activated by the researcher), the aim of the current study is to test the&#xD;
        effectiveness of a co-designed, automated brief alcohol intervention (Health4Her-Automated)&#xD;
        in reducing women's drinking intentions, improving alcohol literacy, and reducing&#xD;
        consumption.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">November 2023</completion_date>
    <primary_completion_date type="Anticipated">October 2023</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>Randomised controlled trial (2 arms) + pilot of modified active arm&#xD;
  The pilot group does not form part of the planned randomised controlled trial or power and sample size calculation, but is included based on findings from the previous phase of this research (e.g. women not having time to complete the intervention onsite). Therefore n~20 women who cannot participate on the day of breast screening will be offered to participate in the modified active arm offsite.</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
      <masking_description>The on-site researcher responsible for recruitment will not be blind to treatment assignment; the participating women self-completing baseline assessment, intervention, immediate post-intervention and 4-week follow-up assessments will be blinded to treatment assignment. The researcher who oversees follow-up assessment data collection will be blinded to treatment assignment.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Drinking intentions</measure>
      <time_frame>immediately post-randomisation</time_frame>
      <description>Change in next-month drinking intentions (5-point scale: 1, not at all; 5, to a very large extent)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Drinking intentions</measure>
      <time_frame>4-weeks post-randomisation</time_frame>
      <description>Change in next-month drinking intentions (5-point scale: 1, not at all; 5, to a very large extent)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Drinking intentions - standard drinks</measure>
      <time_frame>4-weeks post-randomisation</time_frame>
      <description>Change in intended number of standard drinks consumed over the next month (composite of intention frequency/quantity response items)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants intending to reduce alcohol consumption</measure>
      <time_frame>immediately post-randomisation</time_frame>
      <description>Proportion of participants intending to reduce their next-month alcohol consumption (5-point scale: 1, not at all; 5, to a very large extent)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants intending to reduce alcohol consumption</measure>
      <time_frame>4-weeks post-randomisation</time_frame>
      <description>Proportion of participants intending to reduce their next-month alcohol consumption (5-point scale: 1, not at all; 5, to a very large extent)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Knowledge of alcohol as a breast cancer risk factor</measure>
      <time_frame>4-weeks post-randomisation</time_frame>
      <description>Proportion of participants accurately identifying alcohol as a clear risk factor for breast cancer</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Alcohol literacy</measure>
      <time_frame>4-weeks post-randomisation</time_frame>
      <description>Proportion of participants accurately identifying i) the increased breast cancer risk associated with drinking one average restaurant serve of wine a day; ii) the number of standard drinks in an average restaurant serve of red wine; iii) the maximum number of standard drinks per week recommended by current Australian Alcohol Guidelines (multiple-choice questions)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Alcohol consumption</measure>
      <time_frame>4-weeks post-randomisation</time_frame>
      <description>Among women who have had an alcohol drink in the past month, change in alcohol consumption (composite of frequency/quantity response items)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Knowledge of other breast cancer risk factors</measure>
      <time_frame>4-weeks post-randomisation</time_frame>
      <description>Proportion of participants accurately identifying inactivity and excess weight as risk factors for breast cancer</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Health Knowledge, Attitudes, Practice</condition>
    <condition>Alcohol Drinking</condition>
    <arm_group>
      <arm_group_label>Brief alcohol intervention (Health4Her-Automated) + lifestyle health promotion</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The intervention arm will receive:&#xD;
  brief alcohol intervention&#xD;
  lifestyle health promotion focused on physical activity and maintaining a healthy weight for reducing breast cancer risk.&#xD;
  Participants will receive an iPad and earphones to self-complete the intervention. Alcohol and lifestyle information will be delivered by way of an animation on an iPad, and self-completed activities to reinforce intervention content.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Lifestyle health promotion</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>The control arm will receive:&#xD;
  lifestyle health promotion focused on physical activity and maintaining a healthy weight for reducing breast cancer risk.&#xD;
  Participants will receive an iPad and earphones to self-complete the control intervention. Lifestyle information will be delivered by way of an animation on an iPad, and a self-completed activity to reinforce intervention content.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Brief alcohol intervention (Health4Her-Automated)</intervention_name>
      <description>Embedded within the lifestyle health promotion provided in both conditions, participants randomised to the experimental condition will receive a brief alcohol intervention. The brief alcohol intervention will comprise information and behaviour-change content regarding alcohol consumption, including: messaging around alcohol risks/harms (with a focus on alcohol use and breast cancer risk), positive-framed messaging on the health benefits of reducing alcohol intake, and alcohol harm-reduction / behaviour change strategies (e.g. drink counting, goal setting, behaviour substitution, problem solving).&#xD;
  Post-session information will be provided via email (i.e. electronic brochure summarising brief alcohol intervention content).</description>
      <arm_group_label>Brief alcohol intervention (Health4Her-Automated) + lifestyle health promotion</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Lifestyle health promotion</intervention_name>
      <description>Lifestyle health promotion, focused on physical activity and maintaining a healthy weight for reducing breast cancer risk, will be provided.&#xD;
  Post-session information will be provided via email (i.e. electronic brochure summarising nutrition for maintaining a healthy weight).</description>
      <arm_group_label>Brief alcohol intervention (Health4Her-Automated) + lifestyle health promotion</arm_group_label>
      <arm_group_label>Lifestyle health promotion</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Female&#xD;
  &#xD;
            -  40+ years of age&#xD;
  &#xD;
            -  Attending routine breast screening&#xD;
  &#xD;
            -  With or without a breast cancer history&#xD;
  &#xD;
            -  Reporting any level of alcohol consumption&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Not able to read or comprehend English to enable participation&#xD;
  &#xD;
            -  No access to a computer, tablet or smartphone to complete follow-up assessment&#xD;
  &#xD;
            -  Women who are pregnant (also an exclusion from breast screening)&#xD;
  &#xD;
            -  Participation in the pilot Health4Her trial&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jasmin Grigg, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Turning Point, Eastern Health; Monash University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jasmin Grigg, PhD</last_name>
      <phone>+61 3 8413 8723</phone>
      <email>jasmin.grigg@monash.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Dan I Lubman, PhD</last_name>
      <phone>+61 3 8413 8413</phone>
      <email>dan.lubman@monash.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Maroondah BreastScreen</name>
        <address>
          <city>Ringwood East</city>
          <state>Victoria</state>
          <zip>3135</zip>
          <country>Australia</country>
        </address>
      </facility>
      <contact>
        <last_name>Darren Lockie, FRANZCR</last_name>
        <email>dlockie@breastscreen.org.au</email>
      </contact>
    </location>
    <location_countries>
      <country>Australia</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Women's health</keyword>
    <keyword>Public health</keyword>
    <keyword>Health promotion</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Alcohol Drinking</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>There is not Ethics approval to seek patient permission to share data outside this study.</ipd_description>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol and Statistical Analysis Plan</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>August 11, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT06019442/Prot_SAP_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/NCT06019442
  org study id: LR22-071-91112
  nct id: NCT06019442
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Alcohol is a major modifiable risk factor for female breast cancer; yet, awareness of this
        risk remains surprisingly low and is not systematically addressed in healthcare settings.
        This study aim to test the effectiveness of a co-designed, automated brief alcohol
        intervention (Health4Her-Automated) in reducing women's drinking intentions, improving
        alcohol literacy, and reducing consumption.
  Alcohol is a major modifiable risk factor for female breast cancer, even in very low amounts.
        In Australia, alcohol consumption accounts for 6.6 per cent of cases in post-menopausal
        women, and 18 per cent of breast cancer deaths. Yet, awareness of this risk remains low and
        is not systematically addressed in healthcare settings. Embedding a brief alcohol
        intervention within lifestyle information offered to all women attending breast screening
        provides the opportunity to address harmful drinking in a discrete, non-judgmental way, to
        prevent alcohol-attributable breast cancer among this at-risk population.
  
        Brief alcohol interventions are short, single-session programs typically offered in general
        practice settings to gather information on a person's alcohol consumption and, in a non
        confrontational way, provide strategies and motivate change to reduce consumption and related
        risk of harm. An automated brief alcohol intervention, self-completed on a device such as an
        iPad, is a low-cost, labour- and time-efficient approach that overcomes many of the issues of
        providing intervention within busy healthcare environments.
  
        Building on the previous pilot trial of a prototype brief e-health intervention (which
        included alcohol-related questions asked by a researcher, and an animation viewed on an iPad
        that was activated by the researcher), the aim of the current study is to test the
        effectiveness of a co-designed, automated brief alcohol intervention (Health4Her-Automated)
        in reducing women's drinking intentions, improving alcohol literacy, and reducing
        consumption.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomised controlled trial (2 arms) + pilot of modified active arm
  The pilot group does not form part of the planned randomised controlled trial or power and sample size calculation, but is included based on findings from the previous phase of this research (e.g. women not having time to complete the intervention onsite). Therefore n~20 women who cannot participate on the day of breast screening will be offered to participate in the modified active arm offsite.
  primary purpose: Other
  masking: Double (Participant, Outcomes Assessor)
  masking description: The on-site researcher responsible for recruitment will not be blind to treatment assignment; the participating women self-completing baseline assessment, intervention, immediate post-intervention and 4-week follow-up assessments will be blinded to treatment assignment. The researcher who oversees follow-up assessment data collection will be blinded to treatment assignment.
  measure: Drinking intentions
  time frame: immediately post-randomisation
  description: Change in next-month drinking intentions (5-point scale: 1, not at all; 5, to a very large extent)
  measure: Drinking intentions
  time frame: 4-weeks post-randomisation
  description: Change in next-month drinking intentions (5-point scale: 1, not at all; 5, to a very large extent)
  measure: Drinking intentions - standard drinks
  time frame: 4-weeks post-randomisation
  description: Change in intended number of standard drinks consumed over the next month (composite of intention frequency/quantity response items)
  measure: Proportion of participants intending to reduce alcohol consumption
  time frame: immediately post-randomisation
  description: Proportion of participants intending to reduce their next-month alcohol consumption (5-point scale: 1, not at all; 5, to a very large extent)
  measure: Proportion of participants intending to reduce alcohol consumption
  time frame: 4-weeks post-randomisation
  description: Proportion of participants intending to reduce their next-month alcohol consumption (5-point scale: 1, not at all; 5, to a very large extent)
  measure: Knowledge of alcohol as a breast cancer risk factor
  time frame: 4-weeks post-randomisation
  description: Proportion of participants accurately identifying alcohol as a clear risk factor for breast cancer
  measure: Alcohol literacy
  time frame: 4-weeks post-randomisation
  description: Proportion of participants accurately identifying i) the increased breast cancer risk associated with drinking one average restaurant serve of wine a day; ii) the number of standard drinks in an average restaurant serve of red wine; iii) the maximum number of standard drinks per week recommended by current Australian Alcohol Guidelines (multiple-choice questions)
  measure: Alcohol consumption
  time frame: 4-weeks post-randomisation
  description: Among women who have had an alcohol drink in the past month, change in alcohol consumption (composite of frequency/quantity response items)
  measure: Knowledge of other breast cancer risk factors
  time frame: 4-weeks post-randomisation
  description: Proportion of participants accurately identifying inactivity and excess weight as risk factors for breast cancer
  arm group label: Brief alcohol intervention (Health4Her-Automated) + lifestyle health promotion
  arm group type: Experimental
  description: The intervention arm will receive:
  brief alcohol intervention
  lifestyle health promotion focused on physical activity and maintaining a healthy weight for reducing breast cancer risk.
  Participants will receive an iPad and earphones to self-complete the intervention. Alcohol and lifestyle information will be delivered by way of an animation on an iPad, and self-completed activities to reinforce intervention content.
  arm group label: Lifestyle health promotion
  arm group type: Other
  description: The control arm will receive:
  lifestyle health promotion focused on physical activity and maintaining a healthy weight for reducing breast cancer risk.
  Participants will receive an iPad and earphones to self-complete the control intervention. Lifestyle information will be delivered by way of an animation on an iPad, and a self-completed activity to reinforce intervention content.
  intervention type: Behavioral
  intervention name: Brief alcohol intervention (Health4Her-Automated)
  description: Embedded within the lifestyle health promotion provided in both conditions, participants randomised to the experimental condition will receive a brief alcohol intervention. The brief alcohol intervention will comprise information and behaviour-change content regarding alcohol consumption, including: messaging around alcohol risks/harms (with a focus on alcohol use and breast cancer risk), positive-framed messaging on the health benefits of reducing alcohol intake, and alcohol harm-reduction / behaviour change strategies (e.g. drink counting, goal setting, behaviour substitution, problem solving).
  Post-session information will be provided via email (i.e. electronic brochure summarising brief alcohol intervention content).
  arm group label: Brief alcohol intervention (Health4Her-Automated) + lifestyle health promotion
  intervention type: Behavioral
  intervention name: Lifestyle health promotion
  description: Lifestyle health promotion, focused on physical activity and maintaining a healthy weight for reducing breast cancer risk, will be provided.
  Post-session information will be provided via email (i.e. electronic brochure summarising nutrition for maintaining a healthy weight).
  arm group label: Brief alcohol intervention (Health4Her-Automated) + lifestyle health promotion
  arm group label: Lifestyle health promotion
  criteria: 
  gender: Female
  minimum age: 40 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Jasmin Grigg, PhD
  role: Principal Investigator
  affiliation: Turning Point, Eastern Health; Monash University
  last name: Jasmin Grigg, PhD
  phone: +61 3 8413 8723
  email: jasmin.grigg@monash.edu
  last name: Dan I Lubman, PhD
  phone: +61 3 8413 8413
  email: dan.lubman@monash.edu
  facility: 
  contact: 
  country: Australia
  responsible party type: Sponsor
  mesh term: Alcohol Drinking
  sharing ipd: No
  ipd description: There is not Ethics approval to seek patient permission to share data outside this study.
  provided document: 