Clinical trial NCT05665543: Increasing HPV Vaccination in Pediatric, Adolescent, and Young Adult (PAYA) Cancer Survivors
Official title: Increasing HPV Vaccination Coverage Among Pediatric, Adolescent, and Young Adult (PAYA) Cancer Survivors: A Multilevel Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
HPV Associated Cancer
Keywords: HPV vaccine
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2022-12-27
Enrollment: 490
Sex: ALL
Minimum age (years): 9
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Study enrollment
timeFrame: within 6 months of index clinic visit
Secondary outcomes:
measure: Change in HPV and HPV vaccination knowledge pre- and post-intervention
timeFrame: baseline and 1 year post survivorship clinic visit
measure: Number of participants intent to vaccinate against HPV
timeFrame: At the time of index clinic visit, baseline
measure: Proportion of participants intending to vaccinate initiating and completing the vaccine series
timeFrame: 1 year post index clinic visit
measure: Demographics differences associated with vaccination status
timeFrame: 1 year post index clinic visit
measure: Cancer occurrences associated with vaccination status
timeFrame: 1 year post index clinic visit
measure: Treatment differences associated with vaccination status
timeFrame: 1 year post index clinic visit
measure: Number of participants experiencing barriers to vaccination
timeFrame: 1 year post index clinic visit
measure: Number of participants using and accepting the game based learning app
timeFrame: 1 year post index clinic visit
measure: Concordance between reported and documented vaccination against HPV
timeFrame: 1 year post index clinic visit
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Masonic Cancer Center
state: Minnesota
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Deanna Teoh, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: