<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/NCT04469569</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-300005305</org_study_id>
    <secondary_id>1U01CA246567-01A1</secondary_id>
    <nct_id>NCT04469569</nct_id>
  </id_info>
  <brief_title>Provider-Focused Intervention for Maximizing HPV Vaccine Uptake in Young Cancer Survivors</brief_title>
  <official_title>Implementation of a Provider-Focused Intervention for Maximizing HPV Vaccine Uptake in Young Cancer Survivors Receiving Follow-Up Care in Pediatric Oncology Practices: A Cluster-Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alabama at Birmingham</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 focus of this research is on increasing the uptake of the human papillomavirus (HPV)&#xD;
      vaccine in young cancer survivors, a vulnerable population at high risk for developing new&#xD;
      cancers (such as cervical and anal cancer) caused by persistent HPV infection. An effective&#xD;
      vaccine exists that can prevent these cancers, but HPV vaccine uptake is low among young&#xD;
      cancer survivors. This research will evaluate the effectiveness and implementation of an&#xD;
      evidence-based intervention, adapted for use by healthcare providers in pediatric oncology&#xD;
      clinics, to increase the uptake of HPV vaccine among young cancer survivors 9-17 years of&#xD;
      age. Results of this research will provide important information that can be used to&#xD;
      implement new strategies to increase the uptake of the HPV vaccine among young cancer&#xD;
      survivors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Childhood cancer survivors are at high risk for developing new cancers (such as cervical and&#xD;
      anal cancer) caused by persistent infection with the human papillomavirus (HPV). Compared&#xD;
      with the age- and sex-matched general population, female and male cancer survivors have a&#xD;
      1.4- to 2.5-fold excess risk, respectively, of developing HPV-related malignancies.&#xD;
      Fortunately, HPV-related malignancies are largely preventable due to availability of the&#xD;
      nonavalent HPV vaccine, which offers protection against ~90% of oncogenic HPV subtypes. We&#xD;
      have previously shown that uptake of the HPV vaccine is significantly lower in cancer&#xD;
      survivors compared with general population peers (22.0% vs 42.5% in those age 13-17yrs), and&#xD;
      that lack of healthcare provider recommendation is the strongest predictor of HPV vaccine&#xD;
      non-initiation in cancer survivors. Strategies that are most successful in increasing HPV&#xD;
      vaccine uptake in the general population focus on improving healthcare provider knowledge&#xD;
      about the HPV vaccine, enhancing the skills that healthcare providers need to effectively&#xD;
      recommend the vaccine to young people and their parents, and reducing barriers to receiving&#xD;
      the vaccine.&#xD;
&#xD;
      This study will evaluate the effectiveness and implementation of an evidence-based&#xD;
      intervention (HPV-PROTECT), adapted for use by healthcare providers in pediatric oncology&#xD;
      clinics, to increase the uptake of HPV vaccine among young cancer survivors (9 to 17 years of&#xD;
      age and at least one year following completion of cancer therapy). The HPV-PROTECT&#xD;
      intervention has three components: i) Provider Communication Training; ii) Assessment and&#xD;
      Peer Feedback/Coaching; and iii) Provider Toolkit, and is designed to increase provider&#xD;
      knowledge regarding use of the HPV vaccine in the cancer survivor population, enhance&#xD;
      provider skills in delivering brief, compelling HPV vaccine recommendations to parents of&#xD;
      young cancer survivors, present ongoing feedback to providers regarding clinic- and&#xD;
      provider-level survivor HPV vaccination rates, and decrease barriers to receipt of vaccine by&#xD;
      survivors through the provision of Vaccine Action Plans. If the intervention is effective in&#xD;
      improving and sustaining increased uptake of the HPV vaccine in young cancer survivors, this&#xD;
      study will contribute important information needed to move forward with testing the&#xD;
      widespread use of the intervention in pediatric oncology practices.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 1, 2021</start_date>
  <completion_date type="Anticipated">January 31, 2026</completion_date>
  <primary_completion_date type="Anticipated">January 31, 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>Sequential Assignment</intervention_model>
    <intervention_model_description>Cluster-randomized stepped-wedge design with 6 clusters</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HPV vaccine initiation rates</measure>
    <time_frame>12 months following implementation of the HPV-PROTECT Intervention.</time_frame>
    <description>Proportion of cancer survivors, age 9-17y and ≥1y post-completion of cancer therapy, who completed a clinic visit (in-person or via telehealth) at one of the participating sites during the intervention year, and who have initiated the HPV vaccine series, as measured via state vaccine registry data</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Provider perspectives regarding intervention feasibility, acceptability, appropriateness, fidelity</measure>
    <time_frame>Months 11-12 of the Intervention Year (i.e., Year 2 for sites D, E, F and Year 3 for sites A, B, C)]</time_frame>
    <description>Descriptive statistics summarizing provider survey data and qualitatively coded provider interview data integrated to evaluate the feasibility (perceived potential for success), acceptability (perceived need), and appropriateness (perceived fit) of the HPV-PROTECT intervention to the pediatric oncology setting, and provider adherence (fidelity) to intervention components (e.g., delivery of recommendations, developing and communicating vaccine action plans to parents and PCPs)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in provider HPV vaccine-related knowledge and practices</measure>
    <time_frame>12 and 24 months [all sites], and 36 months [sites D, E, F only] following implementation of the HPV-PROTECT Intervention)</time_frame>
    <description>Descriptive statistics summarizing provider HPV vaccine-related knowledge and practices as reported on provider surveys</description>
  </secondary_outcome>
  <other_outcome>
    <measure>HPV vaccine series completion rates</measure>
    <time_frame>12 and 24 months (all sites), and 36 months (sites D, E, F only) following implementation of the HPV-PROTECT Intervention</time_frame>
    <description>Proportion of cancer survivors, age 9-17y, and ≥1y post-completion of cancer therapy, who completed a clinic visit (in-person or via telehealth) at one of the participating sites during the intervention or sustainability years, and who have completed the HPV vaccine series, as measured via state vaccine registry data</description>
  </other_outcome>
  <other_outcome>
    <measure>Sustainability of HPV vaccine initiation rates</measure>
    <time_frame>24 months (all sites) and 36 months (sites D, E, F only) following implementation of the HPV-PROTECT Intervention</time_frame>
    <description>Proportion of cancer survivors, age 9-17y and ≥1y post-completion of cancer therapy, who completed a clinic visit (in person or via telehealth) at one of the participating sites during the intervention and/or sustainability years, and who have initiated the HPV vaccine series, as measured via state vaccine registry data</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">5196</enrollment>
  <condition>Papillomavirus Vaccines</condition>
  <arm_group>
    <arm_group_label>Delayed Intervention</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Sites randomized to the Delayed Intervention Arm (Sites A, B, C) will be assigned to the control condition in Years 1 and 2, to the HPV-PROTECT intervention in Year 3, and to the sustainability condition in Year 4</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Early Intervention</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Sites randomized to the Early Intervention Arm (Sites D, E, F) will be assigned to the control condition in Year 1, to the HPV-PROTECT intervention in Year 2, and to the sustainability condition in Years 3 and 4</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>HPV-PROTECT</intervention_name>
    <description>HPV-PROTECT is a multicomponent provider-focused intervention specifically tailored for use in pediatric oncology settings, addressing important survivor-specific vaccine issues. The intervention is comprised of three components, i) Provider Communication Training; ii) Assessment and Peer Feedback/ Coaching; and iii) Provider Toolkit. The HPV-PROTECT intervention is designed to increase provider knowledge regarding use of the HPV vaccine in the cancer survivor population, enhance provider skills in delivering brief, compelling HPV vaccine recommendations to parents of young cancer survivors, present ongoing feedback to providers regarding clinic- and provider-level survivor HPV vaccination rates, and decrease barriers to receipt of vaccine by survivors through the provision of Vaccine Action Plans, tailored to local context.</description>
    <arm_group_label>Delayed Intervention</arm_group_label>
    <arm_group_label>Early Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. HEALTHCARE PROVIDERS (ONCOLOGISTS, ADVANCED PRACTICE PROVIDERS)&#xD;
&#xD;
               -  ≥18y of age&#xD;
&#xD;
               -  Care for cancer survivors seen in the targeted clinic who are age 9-17y, ≥1y&#xD;
                  off-therapy, and reside in the state where clinic is located&#xD;
&#xD;
               -  Licensed to order vaccines&#xD;
&#xD;
               -  Willing to complete surveys and/or interviews&#xD;
&#xD;
          2. CHILDHOOD CANCER SURVIVORS&#xD;
&#xD;
               -  9-17y of age&#xD;
&#xD;
               -  ≥1y following completion of cancer therapy&#xD;
&#xD;
               -  Reside in the state where clinic is located&#xD;
&#xD;
               -  Receive follow-up care (in person or via telehealth) at the participating sites&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        N/A&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wendy Landier, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Wendy Landier, PhD</last_name>
    <phone>205-638-2120</phone>
    <email>wclandier@uabmc.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lindsey Hageman, MPH</last_name>
    <phone>205-638-2120</phone>
    <email>lihageman@uabmc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wendy Landier, PhD</last_name>
      <phone>205-638-2120</phone>
      <email>wclandier@uabmc.edu</email>
    </contact>
    <contact_backup>
      <last_name>Lindsey Hageman, MPH</last_name>
      <phone>205-638-2120</phone>
      <email>lihageman@uabmc.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Wendy Landier, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>James L Klosky, PhD</last_name>
      <phone>404-712-5791</phone>
      <email>james.klosky@emory.edu</email>
    </contact>
    <investigator>
      <last_name>James L Klosky, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455-0341</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lucie Turcotte, MD, MPH, MS</last_name>
      <email>turc0023@umn.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Wake Forest University Health Sciences</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157-0001</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thomas McLean, MD</last_name>
      <email>tmclean@wakehealth.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Oregon Health and Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239-3098</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Susan Lindemulder, MD</last_name>
      <email>lindemul@ohsu.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Baylor College of Medicine</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030-3411</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria M Gramatges, MD, PhD</last_name>
      <email>gramatge@bcm.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>May 18, 2023</last_update_submitted>
  <last_update_submitted_qc>May 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 19, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Wendy Landier, PhD</investigator_full_name>
    <investigator_title>Professor</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/NCT04469569
org study id: IRB-300005305
secondary id: 1U01CA246567-01A1
nct id: NCT04469569
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The focus of this research is on increasing the uptake of the human papillomavirus (HPV)
      vaccine in young cancer survivors, a vulnerable population at high risk for developing new
      cancers (such as cervical and anal cancer) caused by persistent HPV infection. An effective
      vaccine exists that can prevent these cancers, but HPV vaccine uptake is low among young
      cancer survivors. This research will evaluate the effectiveness and implementation of an
      evidence-based intervention, adapted for use by healthcare providers in pediatric oncology
      clinics, to increase the uptake of HPV vaccine among young cancer survivors 9-17 years of
      age. Results of this research will provide important information that can be used to
      implement new strategies to increase the uptake of the HPV vaccine among young cancer
      survivors.
Childhood cancer survivors are at high risk for developing new cancers (such as cervical and
      anal cancer) caused by persistent infection with the human papillomavirus (HPV). Compared
      with the age- and sex-matched general population, female and male cancer survivors have a
      1.4- to 2.5-fold excess risk, respectively, of developing HPV-related malignancies.
      Fortunately, HPV-related malignancies are largely preventable due to availability of the
      nonavalent HPV vaccine, which offers protection against ~90% of oncogenic HPV subtypes. We
      have previously shown that uptake of the HPV vaccine is significantly lower in cancer
      survivors compared with general population peers (22.0% vs 42.5% in those age 13-17yrs), and
      that lack of healthcare provider recommendation is the strongest predictor of HPV vaccine
      non-initiation in cancer survivors. Strategies that are most successful in increasing HPV
      vaccine uptake in the general population focus on improving healthcare provider knowledge
      about the HPV vaccine, enhancing the skills that healthcare providers need to effectively
      recommend the vaccine to young people and their parents, and reducing barriers to receiving
      the vaccine.

      This study will evaluate the effectiveness and implementation of an evidence-based
      intervention (HPV-PROTECT), adapted for use by healthcare providers in pediatric oncology
      clinics, to increase the uptake of HPV vaccine among young cancer survivors (9 to 17 years of
      age and at least one year following completion of cancer therapy). The HPV-PROTECT
      intervention has three components: i) Provider Communication Training; ii) Assessment and
      Peer Feedback/Coaching; and iii) Provider Toolkit, and is designed to increase provider
      knowledge regarding use of the HPV vaccine in the cancer survivor population, enhance
      provider skills in delivering brief, compelling HPV vaccine recommendations to parents of
      young cancer survivors, present ongoing feedback to providers regarding clinic- and
      provider-level survivor HPV vaccination rates, and decrease barriers to receipt of vaccine by
      survivors through the provision of Vaccine Action Plans. If the intervention is effective in
      improving and sustaining increased uptake of the HPV vaccine in young cancer survivors, this
      study will contribute important information needed to move forward with testing the
      widespread use of the intervention in pediatric oncology practices.
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: Cluster-randomized stepped-wedge design with 6 clusters
primary purpose: Prevention
masking: None (Open Label)
measure: HPV vaccine initiation rates
time frame: 12 months following implementation of the HPV-PROTECT Intervention.
description: Proportion of cancer survivors, age 9-17y and ≥1y post-completion of cancer therapy, who completed a clinic visit (in-person or via telehealth) at one of the participating sites during the intervention year, and who have initiated the HPV vaccine series, as measured via state vaccine registry data
measure: Provider perspectives regarding intervention feasibility, acceptability, appropriateness, fidelity
time frame: Months 11-12 of the Intervention Year (i.e., Year 2 for sites D, E, F and Year 3 for sites A, B, C)]
description: Descriptive statistics summarizing provider survey data and qualitatively coded provider interview data integrated to evaluate the feasibility (perceived potential for success), acceptability (perceived need), and appropriateness (perceived fit) of the HPV-PROTECT intervention to the pediatric oncology setting, and provider adherence (fidelity) to intervention components (e.g., delivery of recommendations, developing and communicating vaccine action plans to parents and PCPs)
measure: Change in provider HPV vaccine-related knowledge and practices
time frame: 12 and 24 months [all sites], and 36 months [sites D, E, F only] following implementation of the HPV-PROTECT Intervention)
description: Descriptive statistics summarizing provider HPV vaccine-related knowledge and practices as reported on provider surveys
measure: HPV vaccine series completion rates
time frame: 12 and 24 months (all sites), and 36 months (sites D, E, F only) following implementation of the HPV-PROTECT Intervention
description: Proportion of cancer survivors, age 9-17y, and ≥1y post-completion of cancer therapy, who completed a clinic visit (in-person or via telehealth) at one of the participating sites during the intervention or sustainability years, and who have completed the HPV vaccine series, as measured via state vaccine registry data
measure: Sustainability of HPV vaccine initiation rates
time frame: 24 months (all sites) and 36 months (sites D, E, F only) following implementation of the HPV-PROTECT Intervention
description: Proportion of cancer survivors, age 9-17y and ≥1y post-completion of cancer therapy, who completed a clinic visit (in person or via telehealth) at one of the participating sites during the intervention and/or sustainability years, and who have initiated the HPV vaccine series, as measured via state vaccine registry data
arm group label: Delayed Intervention
arm group type: Other
description: Sites randomized to the Delayed Intervention Arm (Sites A, B, C) will be assigned to the control condition in Years 1 and 2, to the HPV-PROTECT intervention in Year 3, and to the sustainability condition in Year 4
arm group label: Early Intervention
arm group type: Other
description: Sites randomized to the Early Intervention Arm (Sites D, E, F) will be assigned to the control condition in Year 1, to the HPV-PROTECT intervention in Year 2, and to the sustainability condition in Years 3 and 4
intervention type: Behavioral
intervention name: HPV-PROTECT
description: HPV-PROTECT is a multicomponent provider-focused intervention specifically tailored for use in pediatric oncology settings, addressing important survivor-specific vaccine issues. The intervention is comprised of three components, i) Provider Communication Training; ii) Assessment and Peer Feedback/ Coaching; and iii) Provider Toolkit. The HPV-PROTECT intervention is designed to increase provider knowledge regarding use of the HPV vaccine in the cancer survivor population, enhance provider skills in delivering brief, compelling HPV vaccine recommendations to parents of young cancer survivors, present ongoing feedback to providers regarding clinic- and provider-level survivor HPV vaccination rates, and decrease barriers to receipt of vaccine by survivors through the provision of Vaccine Action Plans, tailored to local context.
arm group label: Delayed Intervention
arm group label: Early Intervention
criteria: 
gender: All
minimum age: 9 Years
maximum age: N/A
healthy volunteers: No
last name: Wendy Landier, PhD
role: Principal Investigator
affiliation: University of Alabama at Birmingham
last name: Wendy Landier, PhD
phone: 205-638-2120
email: wclandier@uabmc.edu
last name: Lindsey Hageman, MPH
phone: 205-638-2120
email: lihageman@uabmc.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Wendy Landier, PhD
investigator title: Professor
sharing ipd: No