<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/NCT03282097</url>
  </required_header>
  <id_info>
    <org_study_id>1501278953</org_study_id>
    <secondary_id>5R01AG055424-05</secondary_id>
    <nct_id>NCT03282097</nct_id>
  </id_info>
  <brief_title>Decisions About Cancer Screening in Alzheimer's Disease</brief_title>
  <acronym>DECAD</acronym>
  <official_title>Decisions About Cancer Screening in Alzheimer's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indiana University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Indiana University</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 Decisions about Cancer screening in Alzheimer's Disease (DECAD) study is the first study&#xD;
      to test if an evidence-based decision aid for AD caregivers can support decision-making about&#xD;
      mammography and improve the quality of medical decision-making about breast cancer screening.&#xD;
      This large randomized controlled trial will recruit up to 450 dyads (900 individual&#xD;
      participants) of older women with AD and a family caregiver, for a goal of 426 dyad baselines&#xD;
      (852 individual participants), from 24 primary care practices in central Indiana to test this&#xD;
      decision aid.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 17, 2017</start_date>
  <completion_date type="Anticipated">June 30, 2024</completion_date>
  <primary_completion_date type="Actual">April 6, 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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Decisional conflict Scale</measure>
    <time_frame>0-5 days after the POST-Index PCP visit</time_frame>
    <description>The DCS includes 16 questions regarding a medical decision that they have made or that they are about to make. It is a validated and widely accepted measure of decision quality that has been used in previous studies of decision aids intended for AD caregivers</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Decision-making self-efficacy</measure>
    <time_frame>Baseline and 0-5 days after the POST-Index post PCP visit</time_frame>
    <description>To measure decision-making self-efficacy, we will use the Decision Self-Efficacy Scale (DSE). The DSE is a validated, 11-item instrument that measures how confident the respondent is in their ability to make an informed medical decision, including SDM. We will adapt the DSE with five response categories (&quot;not at all confident&quot; to &quot;very confident&quot;) to measure caregiver decision-making self-efficacy for mammography decisions for their relative with AD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiver Role in decision making</measure>
    <time_frame>0-5 days after the PCP Index visit</time_frame>
    <description>Adapted from the Control Preferences Scale, this is a 4-item instrument to assess preferences for and involvement in making decisions on their own or sharing responsibility with the patient or doctor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Role in decision making</measure>
    <time_frame>0-5 days after the PCP Index visit</time_frame>
    <description>Adapted from the Control Preferences Scale, this is a 2-item instrument to assess involvement in making decisions on their own or sharing responsibility with their family or doctor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Record of mammogram</measure>
    <time_frame>15 month followup, 24 month EMR data</time_frame>
    <description>We will ask caregivers at the 15 months post-intervention follow-up, via phone-administered questionnaire, if the patient received a mammogram at any time since intervention date and any burdens of the procedure for the patient or for them. We will also review the patient's EMR to assess primary care notes, radiology records, and other documentation of a mammogram outside of the INPC at the 24 months post-intervention follow-up.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">427</enrollment>
  <condition>Cancer, Breast</condition>
  <arm_group>
    <arm_group_label>Mammogram decision aid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Will be mailed the DECAD decision aid before their next PCP visit in order to better inform their decision to continue or stop mammography.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Home safety guide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The home safety guide is a two-page paper pamphlet developed by the American Geriatrics Society Foundation for Health in Aging. It provides tips about important actions older adults can take to prevent falls, poisoning, and bathroom hazards and protection against abuse, fire and other related hazards. We selected the home safety guide to account for the attention given to the intervention group but not to provide information that would bias the control group away from talking about mammography with the patient's PCP.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>DECAD decision aid</intervention_name>
    <description>A mammography decision aid that will help caregivers of patients with Alzheimer's make decisions about stopping or continuing breast cancer screening.</description>
    <arm_group_label>Mammogram decision aid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Home safety guide</intervention_name>
    <description>The home safety guide provides tips about important actions older adults can take to prevent falls, poisoning, and bathroom hazards and protection against abuse, fire and other related hazards.</description>
    <arm_group_label>Home safety guide</arm_group_label>
    <other_name>control group</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Patient Inclusion Criteria:&#xD;
&#xD;
          -  Female and 75 years or older&#xD;
&#xD;
          -  At least one mammogram in the past five years&#xD;
&#xD;
          -  Primary care visit scheduled in the next 12 months&#xD;
&#xD;
          -  Diagnosis of Alzheimer's disease or related dementia as determined by ICD-10 code&#xD;
&#xD;
          -  Ability to provide informed consent or assent&#xD;
&#xD;
          -  Ability to communicate in English&#xD;
&#xD;
        Patient Exclusion Criteria:&#xD;
&#xD;
          -  Permanent resident of a nursing facility&#xD;
&#xD;
          -  Had a mammogram in the past 6 months&#xD;
&#xD;
          -  Primary care visit scheduled is the first visit with the PCP&#xD;
&#xD;
          -  Made a decision to stop getting mammograms&#xD;
&#xD;
          -  History of Atypical Ductal Hyperplasia, lobular carcinoma in situ, ductal carcinoma in&#xD;
             situ, or non-invasive breast cancer&#xD;
&#xD;
          -  Has mild cognitive impairment, serious mental illness such as bipolar or schizophrenia&#xD;
             as determined by ICD-10 code&#xD;
&#xD;
        Caregiver Inclusion Criteria:&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  Primary family caregiver of the patient*&#xD;
&#xD;
          -  Must have a telephone&#xD;
&#xD;
          -  Ability to provide informed consent&#xD;
&#xD;
          -  Ability to communicate in English&#xD;
&#xD;
        Caregiver Exclusion Criteria:&#xD;
&#xD;
          -  Caregiver is a non-family member who is not a legal Healthcare Power of Attorney&#xD;
&#xD;
          -  Less than a 7th grade education**&#xD;
&#xD;
          -  Made a decision that the patient will stop getting mammograms&#xD;
&#xD;
          -  Has a diagnosis of AD or has a serious mental illness such as bipolar or schizophrenia&#xD;
             as determined by ICD-10 code&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>75 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicole Fowler, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Indiana University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Parkview Health</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alzheimer's Association</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eskenazi Health</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IU Health</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>May 15, 2023</last_update_submitted>
  <last_update_submitted_qc>May 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indiana University</investigator_affiliation>
    <investigator_full_name>Nicole R. Fowler, PhD</investigator_full_name>
    <investigator_title>Assistant Professor of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Alzheimer Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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>April 28, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/97/NCT03282097/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03282097
org study id: 1501278953
secondary id: 5R01AG055424-05
nct id: NCT03282097
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The Decisions about Cancer screening in Alzheimer's Disease (DECAD) study is the first study
      to test if an evidence-based decision aid for AD caregivers can support decision-making about
      mammography and improve the quality of medical decision-making about breast cancer screening.
      This large randomized controlled trial will recruit up to 450 dyads (900 individual
      participants) of older women with AD and a family caregiver, for a goal of 426 dyad baselines
      (852 individual participants), from 24 primary care practices in central Indiana to test this
      decision aid.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Decisional conflict Scale
time frame: 0-5 days after the POST-Index PCP visit
description: The DCS includes 16 questions regarding a medical decision that they have made or that they are about to make. It is a validated and widely accepted measure of decision quality that has been used in previous studies of decision aids intended for AD caregivers
measure: Change in Decision-making self-efficacy
time frame: Baseline and 0-5 days after the POST-Index post PCP visit
description: To measure decision-making self-efficacy, we will use the Decision Self-Efficacy Scale (DSE). The DSE is a validated, 11-item instrument that measures how confident the respondent is in their ability to make an informed medical decision, including SDM. We will adapt the DSE with five response categories ("not at all confident" to "very confident") to measure caregiver decision-making self-efficacy for mammography decisions for their relative with AD.
measure: Caregiver Role in decision making
time frame: 0-5 days after the PCP Index visit
description: Adapted from the Control Preferences Scale, this is a 4-item instrument to assess preferences for and involvement in making decisions on their own or sharing responsibility with the patient or doctor.
measure: Patient Role in decision making
time frame: 0-5 days after the PCP Index visit
description: Adapted from the Control Preferences Scale, this is a 2-item instrument to assess involvement in making decisions on their own or sharing responsibility with their family or doctor.
measure: Record of mammogram
time frame: 15 month followup, 24 month EMR data
description: We will ask caregivers at the 15 months post-intervention follow-up, via phone-administered questionnaire, if the patient received a mammogram at any time since intervention date and any burdens of the procedure for the patient or for them. We will also review the patient's EMR to assess primary care notes, radiology records, and other documentation of a mammogram outside of the INPC at the 24 months post-intervention follow-up.
arm group label: Mammogram decision aid
arm group type: Experimental
description: Will be mailed the DECAD decision aid before their next PCP visit in order to better inform their decision to continue or stop mammography.
arm group label: Home safety guide
arm group type: Active Comparator
description: The home safety guide is a two-page paper pamphlet developed by the American Geriatrics Society Foundation for Health in Aging. It provides tips about important actions older adults can take to prevent falls, poisoning, and bathroom hazards and protection against abuse, fire and other related hazards. We selected the home safety guide to account for the attention given to the intervention group but not to provide information that would bias the control group away from talking about mammography with the patient's PCP.
intervention type: Behavioral
intervention name: DECAD decision aid
description: A mammography decision aid that will help caregivers of patients with Alzheimer's make decisions about stopping or continuing breast cancer screening.
arm group label: Mammogram decision aid
intervention type: Other
intervention name: Home safety guide
description: The home safety guide provides tips about important actions older adults can take to prevent falls, poisoning, and bathroom hazards and protection against abuse, fire and other related hazards.
arm group label: Home safety guide
other name: control group
criteria: 
gender: Female
minimum age: 75 Years
maximum age: N/A
healthy volunteers: No
last name: Nicole Fowler, PhD
role: Principal Investigator
affiliation: Indiana University
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Indiana University
investigator full name: Nicole R. Fowler, PhD
investigator title: Assistant Professor of Medicine
mesh term: Breast Neoplasms
mesh term: Alzheimer Disease
sharing ipd: No
provided document: 