<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/NCT04484194</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00002661</org_study_id>
    <nct_id>NCT04484194</nct_id>
  </id_info>
  <brief_title>Assessing Health Electronically for Adolescent and Young Adult Oncology</brief_title>
  <acronym>AHEAD</acronym>
  <official_title>Assessing Health Electronically for Adolescent and Young Adult Oncology (AHEAD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seattle Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tickit Health Solutions</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Seattle Children's Hospital</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>
      The purpose of this study is to modify an existing Seattle Children's Hospital&#xD;
      investigator-developed, patient-centered, electronic health assessment (eHA) called &quot;Check&#xD;
      Yourself&quot; for AYAs with cancer. The investigators will then evaluate the new eHA prototype&#xD;
      for feasibility and acceptability among AYAs with cancer and their oncology providers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Unmet needs among Adolescents and Young Adults (AYAs) with cancer translate to poor physical&#xD;
      and psychosocial outcomes. This is particularly true when it comes to AYA sexual health. Our&#xD;
      team has found that intimate relationships and risky health behaviors are common among AYAs&#xD;
      during their cancer experience, that oncology clinicians rarely ask about these behaviors,&#xD;
      and that AYAs rarely volunteer to share these behaviors. As a result, AYAs with cancer are&#xD;
      deprived of the surveillance, anticipatory guidance, and normative support participants would&#xD;
      have received if participants were well. Currently there is no standard screening process for&#xD;
      risk behaviors and the recommended psychosocial screening for AYAs in the SCH oncology clinic&#xD;
      setting. To address this problem, the investigators propose to adapt a validated AYA-targeted&#xD;
      electronic health assessment (eHA) screening tool for use in oncology clinics.&#xD;
&#xD;
      The purpose of this study is to modify an existing Seattle Children's Hospital&#xD;
      investigator-developed, patient-centered, electronic health assessment (eHA) for AYAs with&#xD;
      cancer. The investigators will then evaluate the new eHA prototype for feasibility and&#xD;
      acceptability among AYAs with cancer and their oncology providers.&#xD;
&#xD;
      AIM 1. To evaluate the modified eHA program prototype for feasibility, acceptability, and&#xD;
      process measures. The investigators will enroll a cohort of N=25 AYAs with cancer and N=10&#xD;
      providers from our institution to &quot;beta-test&quot; the program.&#xD;
&#xD;
      Hypothesis 1: There will be applicable and nonapplicable eHA content for AYAs with cancer in&#xD;
      the current electronic health assessment (eHA) tool in addition to content relative to AYAs&#xD;
      with cancer that should be developed and added.&#xD;
&#xD;
      Hypothesis 2: AYAs will report that the modified AYA oncology specific eHA is both useful and&#xD;
      easy to use. Additionally, oncology providers will report that the eHA tool was useful and&#xD;
      positively impacted patient care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 15, 2021</start_date>
  <completion_date type="Actual">March 31, 2023</completion_date>
  <primary_completion_date type="Actual">March 31, 2022</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Single center pilot feasibility study.</intervention_model_description>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Determine the feasibility of eHA tool in AYA patients undergoing cancer directed therapy.</measure>
    <time_frame>12 months</time_frame>
    <description>Determine the feasibility of Electronic Health Assessment (eHA) tool in AYA population with cancer diagnosis using the feasibility of intervention measure (FIM) tool survey.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Determine the acceptability of eHA tool in AYA patients undergoing cancer directed therapy.</measure>
    <time_frame>12 months</time_frame>
    <description>Determine the acceptability of Electronic Health Assessment (eHA) tool in AYA population with cancer diagnosis using the acceptability of intervention measure (AIM) tool survey.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Determine the usability of eHA tool in AYA patients undergoing cancer directed therapy.</measure>
    <time_frame>12 months</time_frame>
    <description>Determine the usability of Electronic Health Assessment (eHA) tool in AYA population with cancer diagnosis using the usability of intervention of appropriateness measure (IAM) tool survey.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Risk Reduction Behavior</condition>
  <arm_group>
    <arm_group_label>eHA Screening</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receiving eHA screening tool.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Check Yourself - Oncology</intervention_name>
    <description>A validated AYA-targeted electronic health assessment (eHA) screening tool for use in oncology clinics.</description>
    <arm_group_label>eHA Screening</arm_group_label>
    <other_name>Electronic Health Assessment (eHA)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eligible adolescents and young adults will be 13 to 29 years old, have an oncologic&#xD;
             diagnosis for which they are receiving cancer directed therapy, have an appointment to&#xD;
             see an SCH oncology provider and will be able to understand English.&#xD;
&#xD;
          -  Eligible oncology providers will either be a Physician (Fellow or Attending) or&#xD;
             Advance Practice Provider (Nurse Practitioner or Physicians Assistant), have an&#xD;
             appointment to see an adolescent or young adult receiving cancer directed therapy&#xD;
             receiving who is also enrolled on the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants will be excluded from the study if they do not meet age requirements, do&#xD;
             not have an appointment in oncology clinic, lack the means to complete follow-up&#xD;
             interviews (i.e., has neither telephone nor internet access), and/or are not able to&#xD;
             understand English. Our experience in the Seattle region is that, because of English&#xD;
             Language Learning schooling supports, inability to read or understand English is a&#xD;
             barrier for &lt;0.5% of adolescents. Thus, we do not anticipate that language&#xD;
             restrictions will significantly limit the demographic distribution of our&#xD;
             participants.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>29 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tyler G Ketterl, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seattle Children's Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seattle Children's</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>April 11, 2023</last_update_submitted>
  <last_update_submitted_qc>April 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seattle Children's Hospital</investigator_affiliation>
    <investigator_full_name>Tyler Ketterl, MD, MS</investigator_full_name>
    <investigator_title>Assistant Professor, Department of Pediatrics</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04484194
org study id: STUDY00002661
nct id: NCT04484194
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to modify an existing Seattle Children's Hospital
      investigator-developed, patient-centered, electronic health assessment (eHA) called "Check
      Yourself" for AYAs with cancer. The investigators will then evaluate the new eHA prototype
      for feasibility and acceptability among AYAs with cancer and their oncology providers.
Unmet needs among Adolescents and Young Adults (AYAs) with cancer translate to poor physical
      and psychosocial outcomes. This is particularly true when it comes to AYA sexual health. Our
      team has found that intimate relationships and risky health behaviors are common among AYAs
      during their cancer experience, that oncology clinicians rarely ask about these behaviors,
      and that AYAs rarely volunteer to share these behaviors. As a result, AYAs with cancer are
      deprived of the surveillance, anticipatory guidance, and normative support participants would
      have received if participants were well. Currently there is no standard screening process for
      risk behaviors and the recommended psychosocial screening for AYAs in the SCH oncology clinic
      setting. To address this problem, the investigators propose to adapt a validated AYA-targeted
      electronic health assessment (eHA) screening tool for use in oncology clinics.

      The purpose of this study is to modify an existing Seattle Children's Hospital
      investigator-developed, patient-centered, electronic health assessment (eHA) for AYAs with
      cancer. The investigators will then evaluate the new eHA prototype for feasibility and
      acceptability among AYAs with cancer and their oncology providers.

      AIM 1. To evaluate the modified eHA program prototype for feasibility, acceptability, and
      process measures. The investigators will enroll a cohort of N=25 AYAs with cancer and N=10
      providers from our institution to "beta-test" the program.

      Hypothesis 1: There will be applicable and nonapplicable eHA content for AYAs with cancer in
      the current electronic health assessment (eHA) tool in addition to content relative to AYAs
      with cancer that should be developed and added.

      Hypothesis 2: AYAs will report that the modified AYA oncology specific eHA is both useful and
      easy to use. Additionally, oncology providers will report that the eHA tool was useful and
      positively impacted patient care.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single center pilot feasibility study.
primary purpose: Screening
masking: None (Open Label)
measure: Determine the feasibility of eHA tool in AYA patients undergoing cancer directed therapy.
time frame: 12 months
description: Determine the feasibility of Electronic Health Assessment (eHA) tool in AYA population with cancer diagnosis using the feasibility of intervention measure (FIM) tool survey.
measure: Determine the acceptability of eHA tool in AYA patients undergoing cancer directed therapy.
time frame: 12 months
description: Determine the acceptability of Electronic Health Assessment (eHA) tool in AYA population with cancer diagnosis using the acceptability of intervention measure (AIM) tool survey.
measure: Determine the usability of eHA tool in AYA patients undergoing cancer directed therapy.
time frame: 12 months
description: Determine the usability of Electronic Health Assessment (eHA) tool in AYA population with cancer diagnosis using the usability of intervention of appropriateness measure (IAM) tool survey.
arm group label: eHA Screening
arm group type: Experimental
description: Patients receiving eHA screening tool.
intervention type: Behavioral
intervention name: Check Yourself - Oncology
description: A validated AYA-targeted electronic health assessment (eHA) screening tool for use in oncology clinics.
arm group label: eHA Screening
other name: Electronic Health Assessment (eHA)
criteria: 
gender: All
minimum age: 13 Years
maximum age: 29 Years
healthy volunteers: No
last name: Tyler G Ketterl, MD, MS
role: Principal Investigator
affiliation: Seattle Children's Research Institute
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Seattle Children's Hospital
investigator full name: Tyler Ketterl, MD, MS
investigator title: Assistant Professor, Department of Pediatrics
sharing ipd: No