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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLAm App | Experimental | Participants will have access to Game based Learning Avatar navigated mobile (GLAm ) app and will receive the receive the quality improvement (QI) intervention plus the GLAm app. |
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| Usual care | No Intervention | Participants in the control group will not receive the access to the GLAm app. They will receive the quality improvement (QI) intervention only. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLAm app | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of participants intent to vaccinate against HPV |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deanna Teoh, MD, MS | Masonic Cancer Center, University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota Masonic Cancer Center | Minneapolis | Minnesota | 55455 | United States |
At the end of the study, the link between subjects' identifiable identification codes and their identifiable information will be destroyed per the AHC protocol at the time of data disposal. The original data records will be archived for 7 years (in accordance with data practices).
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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Randomized controlled trial
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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 |
| 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 |
| Demographics differences associated with vaccination status | measure through health record review | 1 year post index clinic visit |
| Cancer occurrences associated with vaccination status | measure through health record review | 1 year post index clinic visit |
| Treatment differences associated with vaccination status | measure through health record review | 1 year post index clinic visit |
| Number of participants experiencing barriers to vaccination | Survey measurement | 1 year post index clinic visit |
| Number of participants using and accepting the game based learning app | Survey measurement | 1 year post index clinic visit |
| Concordance between reported and documented vaccination against HPV | measured through surveys and health record review | 1 year post index clinic visit |