Papillomavirus Vaccines
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALHPV-PROTECT
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.
Sponsors
University of Alabama at Birmingham
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Cluster-randomized stepped-wedge design with 6 clusters
Eligibility
Sex/Gender
ALL
Age
9 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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 2. 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
Exclusion criteria
N/A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HPV Vaccine Initiation Rates | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Descriptive statistics summarizing provider survey data and qualititatively coded provider interview data were integrated to evaluate the feasability, acceptability, and appropriateness of the HPV-PROTECT intervention to the pediatric oncology setting, and provider adherence (fidelity) to intervention components. Quantitative item: Change in healthcare provider practice of recommending HPV vaccine to their patients (item 13c): Percentage of participants reporting "often/always" |
| 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 healthcare provider HPV and HPV vaccine-related knowledge, as measured quantitatively via 16 survey items, and reported as a combined mean score of proportion of items answered correctly (lowest possible mean score: 0; highest possible mean score: 1.0). A higher score indicates more HPV vaccine-related knowledge. |
| Change in Provider HPV Vaccine-related Practices | Quantitative survey administered to providers at end of pre-intervention, intervention, and sustainability phases of the study. | Change in HPV vaccine-related practices, as measured by the mean score +/- standard deviation of the healthcare provider survey responses to the following items: (a) "I order the HPV vaccine to be given to my patients in the pediatric oncology clinic" and (b) "I check to make sure that my patients complete the HPV vaccine series." Each of these two items were rated by the providers using a Likert scale with the lowest possible score of 1 ("Never") and the highest possible score of 5 ("Always"). Outcomes are reported as the Mean and Standard Deviation of the Likert scale score for each of these two survey items. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORWendy Landier, PhD
University of Alabama at Birmingham
Participant flow
Recruitment details
Patients included all cancer survivors, age 9-17y and ≥1y post-completion of cancer therapy, who completed a clinic visit at one of the sites during at least one study year, resided in the state where the clinic is located, and had a record in the state vaccine registry were included. Providers included all healthcare providers licensed to order vaccines who were caring for cancer survivors, age 9-17y and ≥1y post-completion of cancer therapy at one of the sites during at least one study year
Pre-assignment details
Patients who continued to meet inclusion criteria were included in each study year during which they completed at least one clinic visit at a participating site. Healthcare providers who continued to meet inclusion criteria were invited to participate in each study year during which they continued to care for cancer survivors at a participating site
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 12.7 years STANDARD_DEVIATION 2.48 |
| Age, Customized 30-39 years | 39 Participants |
| Age, Customized 40-49 years | 86 Participants |
| Age, Customized 50-59 years | 16 Participants |
| Age, Customized 60 years and older | 33 Participants |
| Age, Customized Less than 30 years | 7 Participants |
| Race/Ethnicity, Customized Hispanic | 944 Participants |
| Race/Ethnicity, Customized Missing | 5 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 393 Participants |
| Race/Ethnicity, Customized Non-Hispanic Other | 231 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 3867 Participants |
| Sex: Female, Male Female | 1370 Participants |
| Sex: Female, Male Male | 1720 Participants |
| Sex/Gender, Customized Sex/Gender, Customized Female | 69 Participants |
| Sex/Gender, Customized Sex/Gender, Customized Male | 30 Participants |
| Sex/Gender, Customized Sex/Gender, Customized Missing | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 105 | 0 / 70 | 0 / 100 |
| other Total, other adverse events | 0 / 105 | 0 / 70 | 0 / 100 |
| serious Total, serious adverse events | 0 / 105 | 0 / 70 | 0 / 100 |
Outcome results
None listed