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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8,120
- 试验地点
- 6
- 主要终点
- HPV vaccine initiation rates
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HEALTHCARE PROVIDERS (ONCOLOGISTS, ADVANCED PRACTICE PROVIDERS)
- •≥18y of age
- •Care for cancer survivors seen in the targeted clinic who are age 9-17y, ≥1y off-therapy, and reside in the state where clinic is located
- •Licensed to order vaccines
- •Willing to complete surveys and/or interviews
- •CHILDHOOD CANCER SURVIVORS
- •9-17y of age
- •≥1y following completion of cancer therapy
- •Reside in the state where clinic is located
- •Receive follow-up care (in person or via telehealth) at the participating sites
排除标准
- 未提供
研究组 & 干预措施
Delayed Intervention
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
干预措施: HPV-PROTECT (Behavioral)
Early Intervention
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
干预措施: HPV-PROTECT (Behavioral)
结局指标
主要结局
HPV vaccine initiation rates
时间窗: 12 months following implementation of the HPV-PROTECT Intervention.
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
HPV Vaccine Initiation Rates
时间窗: The survivor must have initiated the HPV vaccine as of the final day of the study year
The primary outcome was the percentage 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 study year, and who had initiated the HPV vaccine series as of the final day of the study year, as measured via state vaccine registry records.
次要结局
- Change in provider HPV vaccine-related knowledge and practices(12 and 24 months [all sites], and 36 months [sites D, E, F only] following implementation of the HPV-PROTECT Intervention))
- Provider perspectives regarding intervention feasibility, acceptability, appropriateness, fidelity(Months 11-12 of the Intervention Year (i.e., Year 2 for sites D, E, F and Year 3 for sites A, B, C)])
- Provider Perspectives Regarding Intervention Feasibility, Acceptability, Appropriateness, Fidelity(Qualitative interviews: Months 11-12 of the Intervention Year (i.e., Year 2 for sites D, E, F, and Year 3 for sites A, B, C); Quantitative survey: Administered to providers at end of pre-intervention, intervention, and sustainability phases of the study.)
- Change in Provider HPV Vaccine-related Knowledge(Quantitative survey administered to providers at end of pre-intervention, intervention, and sustainability phases of the study.)
- Change in Provider HPV Vaccine-related Practices(Quantitative survey administered to providers at end of pre-intervention, intervention, and sustainability phases of the study.)
研究者
Wendy Landier, PhD
Professor
University of Alabama at Birmingham