HPVIQ-PedOnc Intervention in Maximizing HPV Vaccine Uptake in Young Cancer Survivors

Active:	Yes
Cancer Type:	Hematopoietic Malignancies Solid Tumor	NCT ID:	NCT04469569
Trial Phases:		Protocol IDs:	XUAB2035 (primary) NCI-2021-00009
Eligibility:	9 Years and older, Male and Female	Study Type:	Prevention
Study Sponsor:	University of Alabama at Birmingham Cancer Center
NCI Full Details:	http://clinicaltrials.gov/show/NCT04469569

Summary

This clinical trial evaluates the impact of implementing an evidence-based, provider-focused intervention called HPVIQ-PedOnc on human papillomavirus (HPV) vaccination rates in young cancer survivors. HPVIQ-PedOnc 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 HPVIQ-PedOnc 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. HPVIQ-PedOnc may increase the uptake of the HPV vaccine and ultimately decrease the risk of developing HPV-related cancers in young cancer survivors.

Objectives

PRIMARY OBJECTIVE:
I. Among childhood cancer survivors 9-17 year (y) and >= 1y post-completion of cancer therapy (targeted age/time frame for vaccination) who are returning for follow-up care (in-person or via telehealth) across 6 geographically-diverse pediatric oncology clinics: Conduct a cluster-randomized, stepped wedge trial to evaluate the effectiveness of HPVIQPedOnc, in improving HPV vaccine initiation rates 1y post-intervention.

SECONDARY OBJECTIVES:
I. Ascertain healthcare provider perspectives regarding feasibility, acceptability, and appropriateness of HPVIQ-PedOnc in the pediatric oncology setting.
II. Assess intervention fidelity.
III. Estimate change in healthcare provider HPV vaccine-related knowledge and practices.

EXPLORATORY OBJECTIVE:
I. Estimate the effect of HPVIQ-PedOnc on: series completion; and ongoing improvement in initiation rates in the years subsequent to HPVIQ-PedOnc implementation (sustainability).

OUTLINE: Sites are randomized to 1 of 2 groups.

GROUP I (EARLY INTERVENTION [SITES A, B, C]): During Year 1, sites proceed with usual care and measure HPV vaccination rates of the targeted population using state vaccine registry data accessible via the electronic medical record (EMR) at their site. In Years 2 and 3, sites implement HPVIQ-PedOnc. In Year 4, sustainability of HPVIQ-PedOnc is assessed at the sites.

GROUP II (DELAYED INTERVENTION [SITES D, E, F]): During Years 1 and 2, sites proceed with usual care and measure HPV vaccination rates of the targeted population using state vaccine registry data accessible via the EMR at their site. In Year 3, sites implement HPVIQ-PedOnc. In Year 4, sustainability of HPVIQ-PedOnc is assessed at the sites.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.