CancerNCT05665543
Increasing HPV Vaccination in Pediatric, Adolescent, and Young Adult (PAYA) Cancer Survivors
A study testing GLAm app in people with Cancer and HPV Associated Cancer, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 9 to 26 years
- Conditions the study is for
- Cancer, HPV Associated Cancer
- What is being tested?
- GLAm app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2023to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, 55455
About this study
Official title: Increasing HPV Vaccination Coverage Among Pediatric, Adolescent, and Young Adult (PAYA) Cancer Survivors: A Multilevel Intervention
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
Read the 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.
- Conditions
- Cancer, HPV Associated Cancer
- Being tested
- GLAm app
- Keywords
- HPV vaccine
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLAm appBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: GLAm app |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study enrollment
Number of participants who complete the 3-dose HPV vaccine series within 12 months of study enrollment.
Measured: within 6 months of index clinic visit
Secondary outcomes (9)
Change in HPV and HPV vaccination knowledge pre- and post-intervention
The change in knowledge is assessed through self reported surveys administered to participants
Measured: baseline and 1 year post survivorship clinic visit
Number of participants intent to vaccinate against HPV
The number of participants with intent to vaccinate is assessed through self reported surveys administered to participants
Measured: 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
Measured: 1 year post index clinic visit
Demographics differences associated with vaccination status
measure through health record review
Measured: 1 year post index clinic visit
Cancer occurrences associated with vaccination status
measure through health record review
Measured: 1 year post index clinic visit
Treatment differences associated with vaccination status
measure through health record review
Measured: 1 year post index clinic visit
Number of participants experiencing barriers to vaccination
Survey measurement
Measured: 1 year post index clinic visit
Number of participants using and accepting the game based learning app
Survey measurement
Measured: 1 year post index clinic visit
Concordance between reported and documented vaccination against HPV
measured through surveys and health record review
Measured: 1 year post index clinic visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start24 Jul 2023
- Primary completion15 Aug 2025
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deanna Teoh, MD, MS, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05665543
- Sponsor's protocol ID
- 2021LS099
- Status last verified
- Aug 2026
- First submitted
- 19 Dec 2022
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing HPV Vaccination Coverage Among Pediatric, Adolescent, and Young Adult (PAYA) Cancer Survivors: A Multilevel Intervention
- ClinicalTrials.gov ID
- NCT05665543
- Acronym / sponsor ID
- 2021LS099
- Conditions
- Cancer, HPV Associated Cancer
- Keywords
- HPV vaccine
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- Oct 2026 (estimated)
- First posted
- 27 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| GLAm App | Experimental | Behavioral: GLAm appParticipants 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. |
| 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. |
Who may qualify
- Ages
- 9 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLAm appGame-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. | Behavioural | GLAm App |
Primary outcome
Study enrollment
Time frame: within 6 months of index clinic visit
Number of participants who complete the 3-dose HPV vaccine series within 12 months of study enrollment.
9 secondary outcomes
Change in HPV and HPV vaccination knowledge pre- and post-intervention
Time frame: baseline and 1 year post survivorship clinic visit
Number of participants intent to vaccinate against HPV
Time frame: At the time of index clinic visit, baseline
Proportion of participants intending to vaccinate initiating and completing the vaccine series
Time frame: 1 year post index clinic visit
Demographics differences associated with vaccination status
Time frame: 1 year post index clinic visit
Cancer occurrences associated with vaccination status
Time frame: 1 year post index clinic visit
Treatment differences associated with vaccination status
Time frame: 1 year post index clinic visit
Number of participants experiencing barriers to vaccination
Time frame: 1 year post index clinic visit
Number of participants using and accepting the game based learning app
Time frame: 1 year post index clinic visit
Concordance between reported and documented vaccination against HPV
Time frame: 1 year post index clinic visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deanna Teoh, MD, MS principal investigator
Masonic Cancer Center, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GLAm app in people with Cancer and HPV Associated Cancer, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study enrollment (time frame: within 6 months of index clinic visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.