Increasing HPV Vaccination in Pediatric, Adolescent, and Young Adult (PAYA) Cancer Survivors

Cancer Clinical Trial

Official title:

Increasing HPV Vaccination Coverage Among Pediatric, Adolescent, and Young Adult (PAYA) Cancer Survivors: A Multilevel Intervention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05665543
• Other study ID #: 2021LS099
• Status: Recruiting
• Phase: N/A
• Start date: July 24, 2023
• Est. completion date: August 2026

Study information

• Verified date: December 2023
• Source: Masonic Cancer Center, University of Minnesota
• Contact: Deanna Teoh, MD, MS
• Phone: 612-625-6503
• Email: dkteoh[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objectives of this study are to increase HPV vaccination initiation and 3-dose completion among pediatric, adolescent, and young adult (PAYA) cancer survivors

Description:

PAYA cancer survivors are 2.8 times more likely to develop a secondary human papillomavirus (HPV)-associated cancer than the general population. Unfortunately, HPV vaccination coverage among PAYA cancer survivors is even lower than that in the general population. Provision of adequate vaccine information and instructions for timing of vaccination post-treatment is associated with an increased intention to vaccinate. Nonetheless, research show a minority of cancer care teams specifically discuss HPV vaccination with PAYA cancer survivors and their caregivers. The purpose of this study is to test the efficacy of an oncologist- and clinic-level intervention and the additional effect of a patient-level app-based intervention to improve initiation and 3-dose completion of the HPV vaccine series.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 490
• Est. completion date: August 2026
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 26 Years

Eligibility

Inclusion Criteria:

• Current patient in the University of Minnesota CCSP clinic or the Children's Minnesota Long-Term Follow-up (LTFU) Program clinic.
• Patients seen in the CCSP clinic who do not have a history of cancer but who have received immunosuppressive therapy or HSCT for treatment of a hematologic disorder.
• Survivor of childhood cancer (defined as diagnosed with cancer at age 25 years or younger) who is currently 18-26 years of age OR a caregiver of a survivor of childhood cancer who is currently 9-17 years of age.
• 6+ months post-treatment; current treatment for graft-versus-host disease allowed
• No previous HPV vaccination or incomplete HPV vaccination (defined as <3 doses post-cancer therapy). Individuals who are unsure of their HPV vaccination status who are unable to find vaccination records per the procedures detailed in Section 5.2, EHR support will be eligible, in concordance with real-world clinical practice regarding HPV vaccination.

Exclusion Criteria:

• Previous completion of the HPV vaccination series. Those who are eligible for re-vaccination per the CDC guidelines will be encouraged by their oncologist to re-vaccinate, but will not be included in the QI study or RCT.
• Unable to read/write in English per self-report (only applies to participants in the RCT [Aim 2]).
• Pregnant at the time of enrollment or plans to become pregnant in the next year. Pregnancy test at the time of enrollment is not required if pregnancy not clinically suspected in concordance with clinical guidelines for HPV vaccine administration.
• Currently receiving treatment for cancer or hematologic disorder or plan for treatment within 12 months of enrollment; treatment for graft-versus-host disease allowed.
• Other contraindications to the HPV vaccine (e.g. history of immediate hypersensitivity reaction to any vaccine component, including yeast).

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• GLAm app
Game-based Learning Avatar-navigated mobile (app) provides information on HPV infection susceptibility, risk of HPV-associated cancers, screening methods, and ways to overcome screening barriers. Users navigate the app using an avatar, and earn points for game components completed. The app prompts screening using text message reminders based on patient-entered information, and links to schedule cervical cancer screening. Completing cervical cancer screening earns an electronic badge visible to other users via an anonymous screen name and avatar.

Locations

Country	Name	City	State
United States	University of Minnesota Masonic Cancer Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study enrollment	Number of participants who complete the 3-dose HPV vaccine series within 12 months of study enrollment.	within 6 months of index clinic visit
Secondary	Change in HPV and HPV vaccination knowledge pre- and post-intervention	The change in knowledge is assessed through self reported surveys administered to participants	baseline and 1 year post survivorship clinic visit
Secondary	Number of participants intent to vaccinate against HPV	The number of participants with intent to vaccinate is assessed through self reported surveys administered to participants	At the time of index clinic visit, baseline
Secondary	Proportion of participants intending to vaccinate initiating and completing the vaccine series	The Proportion of participants intending to vaccinate initiating and completing the vaccine series is measured through surveys and health record review	1 year post index clinic visit
Secondary	Demographics differences associated with vaccination status	measure through health record review	1 year post index clinic visit
Secondary	Cancer occurrences associated with vaccination status	measure through health record review	1 year post index clinic visit
Secondary	Treatment differences associated with vaccination status	measure through health record review	1 year post index clinic visit
Secondary	Number of participants experiencing barriers to vaccination	Survey measurement	1 year post index clinic visit
Secondary	Number of participants using and accepting the game based learning app	Survey measurement	1 year post index clinic visit
Secondary	Concordance between reported and documented vaccination against HPV	measured through surveys and health record review	1 year post index clinic visit