GLAm App for Cancer Survivors' HPV Vaccination

Overseen By Deanna Teoh, MD, MS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Masonic Cancer Center, University of Minnesota

Disqualifiers: Pregnancy, Current cancer treatment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a mobile app called GLAm can increase HPV vaccination rates among young cancer survivors. The goal is to determine if the app encourages more people to start and complete the full HPV vaccine series. Participants will either use the app or receive usual care without it. This trial suits cancer survivors aged 18-26 or caregivers of survivors aged 9-17 who haven't completed the HPV vaccine series and are at least six months past cancer treatment. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve vaccination rates and health outcomes for young cancer survivors.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it allows treatment for graft-versus-host disease, so you may be able to continue some treatments.

What prior data suggests that the GLAm app is safe for cancer survivors?

Research shows that the GLAm app educates and motivates people about the HPV (human papillomavirus) vaccine. The app uses a fun, game-like approach, allowing users to earn digital rewards while learning about the vaccine's importance.

Studies evaluating the app's usability and enjoyment found that participants considered the GLAm app user-friendly and enjoyable. This indicates that people generally like using the app and encounter no major issues. These studies have reported no negative effects related to the app.

As a digital tool, the GLAm app does not have the same safety concerns as a drug or vaccine. Instead, its safety involves user interaction and whether users find it helpful and easy to use. So far, feedback has been positive. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The GLAm app is unique because it offers a game-based learning experience specifically designed for cancer survivors to enhance HPV vaccination uptake. Unlike traditional healthcare interventions that might rely solely on information sessions or reminders, the GLAm app uses an interactive avatar to guide users through educational content, making the learning process engaging and personalized. Researchers are excited about this approach because it combines quality improvement strategies with innovative technology, potentially increasing awareness and acceptance of HPV vaccination in a fun and effective way.

What evidence suggests that the GLAm app is effective for increasing HPV vaccination among cancer survivors?

Research shows that the GLAm app, available to participants in this trial, might help increase HPV vaccination rates among cancer survivors. The app employs a fun, game-like approach to educate and motivate users. One study found that people considered the app easy to use, enhancing its effectiveness in encouraging vaccinations. The app is based on a method that changes behavior by making tasks simple and engaging. While direct data on its impact on HPV vaccination is still being gathered, early signs suggest it could effectively support vaccination efforts. ^{1 3 5 6 7}

Who Is on the Research Team?

Deanna Teoh, MD, MS

Principal Investigator

Masonic Cancer Center, University of Minnesota

Are You a Good Fit for This Trial?

This trial is for pediatric, adolescent, and young adult cancer survivors aged 9-26 who are patients at specific clinics. It's also open to those treated for hematologic disorders with immunosuppression or HSCT. Participants must be at least 6 months post-treatment and either have not started or not completed the HPV vaccine series.

Inclusion Criteria

I've had a bone marrow transplant or immune system treatment for a blood disorder, but I've never had cancer.

You are currently receiving treatment at the University of Minnesota CCSP clinic or the Children's Minnesota Long-Term Follow-up (LTFU) Program clinic.

I was diagnosed with cancer before 26 and am now 18-26, or I care for someone who was and is now 9-17.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either the usual care with quality improvement intervention or the GLAm app with quality improvement intervention

6 months

Regular clinic visits as per intervention protocol

Follow-up

Participants are monitored for HPV vaccination initiation and completion, as well as other secondary outcomes

1 year

Surveys and health record reviews

What Are the Treatments Tested in This Trial?

Interventions

• GLAm app

Trial Overview The study aims to increase HPV vaccination rates among young cancer survivors using a digital application called GLAm app. The focus is on starting and completing the three-dose HPV vaccine regimen in this vulnerable population.

How Is the Trial Designed?

Group I: GLAm App Experimental Treatment 1 Intervention

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.

Group II: Usual care Active Control 1 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 Is Running the Clinical Trial?

Masonic Cancer Center, University of Minnesota

Lead Sponsor

Trials

285

Recruited

15,700+

Published Research Related to This Trial

HPV vaccination, using either Gardasil® or Cervarix®, is a highly effective primary prevention strategy against cervical cancer and other HPV-related diseases, with effects lasting at least 5 years.

Both vaccines are well tolerated, with serious side effects occurring in less than 0.1% of recipients, making them a safe option for adolescents as part of comprehensive cervical cancer prevention programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Position paper--HPV and the primary prevention of cancer; improving vaccine uptake by paediatricians. Ramet, J., van Esso, D., Meszner, Z.[2022]

The HPV vaccine is crucial for females who are cancer survivors, as they are at higher risk for HPV-related complications due to the effects of cancer treatment, and guidelines recommend vaccination for all eligible survivors.

Despite the vaccine's approval in 2006, there is limited understanding of the factors influencing HPV vaccination uptake among cancer survivors, highlighting the need for targeted strategies to improve adherence to vaccination recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human papillomavirus vaccination in survivors of childhood cancer. Klosky, JL., Gamble, HL., Spunt, SL., et al.[2021]

Childhood cancer survivors are at a higher risk of missed opportunities for receiving the HPV vaccine compared to their peers without cancer, with 70% of survivors missing these opportunities versus 59% in the general population sample.

Factors such as higher parental education, living in rural areas, receiving chemotherapy, and younger age at first vaccination were linked to increased missed opportunities, highlighting the need for healthcare providers to actively recommend HPV vaccination during routine vaccine encounters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Missed opportunities for concomitant HPV vaccination among childhood cancer survivors. Ramsay, JM., Kaddas, HK., Ou, JY., et al.[2022]

Childhood cancer survivors often do not fully understand their health risks related to cancer treatment, with a survey of 528 participants showing many are unaware of late effects and less fearful of recurrence compared to their parents.

Web-based platforms like Passport for Care can significantly improve access to health information and awareness about late effects of cancer treatment, potentially enhancing adherence to follow-up care and facilitating further research on survivor health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Childhood Cancer Survivor Care Through Web-Based Platforms. Gramatges, MM., Bonaduce de Nigris, F., King, J., et al.[2018]

In a study involving nearly 30,000 girls and women, the HPV-16/18 Cervarix vaccine showed a favorable safety profile, with no significant differences in serious adverse events or new onset chronic diseases compared to control groups.

While the HPV vaccine group reported higher rates of local and general symptoms, compliance with the vaccination schedule was high (93.4%), indicating that the vaccine is well-tolerated overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine for cervical cancer prevention: a pooled analysis of 11 clinical trials. Descamps, D., Hardt, K., Spiessens, B., et al.[2019]

In a multicenter cohort study involving 147 girls aged 9-26 years, adverse events following HPV vaccination were actively monitored, revealing that most reported reactions were mild or moderate, primarily occurring within the first 5 days post-vaccination.

The most common adverse events included local reactions like pain, swelling, and erythema at the injection site, along with headaches and muscle pain, consistent with findings from previous trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Active surveillance evaluation of anti-HPV vaccine adverse events in Umbria region]. Gianfredi, V., Paoloni, MC., Villarini, M., et al.[2018]

A review of 23 studies found that mobile phone applications are feasible and acceptable tools for supporting cancer survivors during their transition from active treatment to follow-up care, particularly in promoting health through exercise and dietary changes.

Despite the potential benefits, the review highlighted a lack of robust evidence from randomized controlled trials (only three identified), indicating a need for more rigorous studies to better understand the effectiveness of these apps in improving quality of life and self-reported outcomes for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of smartphone applications for cancer survivors. Changrani, K., Chima, S., Sharma, A., et al.[2023]

In a pilot study involving 26 female childhood cancer survivors, the Health Storylines mHealth app was used frequently, with some participants accessing it up to 902 times, but overall, there were no statistically significant improvements in self-efficacy, perceived illness, or health-related quality of life after 3 or 6 months of use.

The study highlighted that while the app's mental health component was utilized by all participants, the effectiveness varied significantly between high and low users, suggesting that further research is needed to identify which individuals benefit most from such mHealth interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use and Effect of the Health Storylines mHealth App on Female Childhood Cancer Survivors' Self-efficacy, Health-Related Quality of Life and Perceived Illness. Cantrell, MA., Ruble, K., Mensinger, J., et al.[2022]

Cancer survivors showed high acceptance of eHealth applications for self-management, but the actual use of mHealth applications was relatively low, indicating a gap between acceptance and adoption.

Younger, more educated, married, employed, and higher-income cancer survivors were more likely to use these applications, while those who were newly diagnosed or still undergoing treatment sought online information and electronic communication with healthcare providers more frequently.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance and Use of eHealth/mHealth Applications for Self-Management Among Cancer Survivors. Jiang, Y., West, BT., Barton, DL., et al.[2018]

A pilot study involving 20 adolescent and young adult cancer patients showed that using a smartphone app for 6 weeks significantly improved quality of life (QoL) in those who were post-treatment, with a notable increase in their overall QoL scores.

The study indicates that mobile health (mHealth) tools like this app are feasible and may provide beneficial support for AYA cancer patients, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health-Related Quality of Life Before and After Use of a Smartphone App for Adolescents and Young Adults With Cancer: Pre-Post Interventional Study. Pappot, H., Assam Taarnhøj, G., Elsbernd, A., et al.[2023]

The HPV vaccine is crucial for females who are survivors of childhood cancer, as they are at a higher risk for HPV-related complications due to the effects of cancer treatment.

The Children's Oncology Group recommends HPV vaccination for all eligible female survivors of childhood cancer, highlighting the need for strategies to improve vaccination uptake among this vulnerable group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human papillomavirus vaccination and the primary prevention of cancer: implications for survivors of childhood cancer. Klosky, JL., Foster, RH., Hodges, J., et al.[2018]

In a study of 592 patients aged 11-26 years, those in a childhood cancer survivor program (CCSP) had HPV vaccination coverage of 60.0%, which was not significantly different from the 66.3% coverage in matched controls without cancer.

Despite similar vaccination rates, only 8.0% of survivorship care plans recommended HPV vaccination, highlighting that initiation and completion of the recommended 3-dose series remain low in this high-risk population for secondary HPV-associated cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HPV vaccination coverage for pediatric, adolescent and young adult patients receiving care in a childhood cancer survivor program. Thomaier, L., Aase, DA., Vogel, RI., et al.[2022]

Only 23.8% of cancer survivors initiated the HPV vaccine, which is significantly lower than the 40.5% initiation rate in the general US population, highlighting a critical gap in vaccination among this high-risk group.

Key factors contributing to the low initiation rates include the absence of a healthcare provider's recommendation and perceived barriers such as lack of insurance coverage, indicating that targeted interventions are needed to improve vaccine uptake among cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human Papillomavirus Vaccination Rates in Young Cancer Survivors. Klosky, JL., Hudson, MM., Chen, Y., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10445170/

Usability and Satisfaction Testing of Game-Based Learning ... We developed a web app, Game-based Learning Avatar-navigated mobile (GLAm), to educate and motivate cervical cancer screening using the Fogg Behavioral Model ...

2. formative.jmir.org formative.jmir.org/2023/1/e45541

Usability and Satisfaction Testing of Game-Based Learning ... We developed a web app, Game-based Learning Avatar-navigated mobile (GLAm), to educate and motivate cervical cancer screening using the Fogg Behavioral Model ...

3. apps.dtic.mil apps.dtic.mil/sti/trecms/pdf/AD1223442.pdf

Increasing HPV Vaccination Coverage Among ... - DTIC The study will also test the efficacy of a game-based learning avatar-navigated mobile (GLAm) app versus usual care at the patient/caregiver ...

4. apps.dtic.mil apps.dtic.mil/sti/trecms/pdf/AD1191014.pdf

Increasing HPV Vaccination Coverage Among ... - DTIC The study will also test the efficacy of a game-based learning avatar-navigated mobile (GLAm) app versus usual care at the patient/caregiver ...

5. researchgate.net researchgate.net/figure/HPV-vaccination-coverage-at-least-1-dose-among-PAYA-cancer-survivors-by-clinical_tbl1_363373307

HPV vaccination coverage (at least 1 dose) among PAYA ... Mean scores showed the app was perceived to be easy to use (mean score 6.17, SD 0.27) and moderately useful to increase cervical cancer screening knowledge and ...

6. glam.ahc.umn.edu glam.ahc.umn.edu/

GLAM Using this app will allow you to earn digital rewards while you learn information about HPV vaccination specifically tailored for survivors of childhood cancer.

7. researchgate.net researchgate.net/publication/366400867_Reasons_for_refusal_of_the_human_papillomavirus_vaccine_among_young_cancer_survivors

Reasons for refusal of the human papillomavirus vaccine ... HPV vaccination is effective in preventing the infections that lead to these cancers, but HPV vaccine uptake is low among young cancer survivors. Lack of a ...