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

490 Participants Needed

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the GLAm app treatment for cancer survivors' HPV vaccination?

Research shows that web-based platforms and mobile apps can improve access to health information and enhance awareness among cancer survivors, which may support better health management. Although not specific to HPV vaccination, these tools have potential to improve self-management and quality of life in cancer survivors. ^{1 2 3 4 5}

Is the GLAm App for Cancer Survivors' HPV Vaccination safe for humans?

The safety of the HPV vaccine, which is relevant to the GLAm App for Cancer Survivors' HPV Vaccination, has been evaluated in a large study involving nearly 30,000 participants. The study found that the vaccine has a favorable safety profile, with no significant differences in serious adverse events or new chronic diseases compared to control groups. ^{6 7 8 9 10}

How does the GLAm app treatment for HPV vaccination in cancer survivors differ from other treatments?

The GLAm app is unique because it is a digital tool designed to support cancer survivors in adhering to HPV vaccination recommendations, which is crucial for preventing HPV-related complications in this high-risk group. Unlike traditional treatments, this app focuses on improving vaccination uptake and adherence through personalized reminders and educational resources, addressing the specific needs of cancer survivors. ^{6 10 11 12 13}

Research Team

Deanna Teoh, MD, MS

Principal Investigator

Masonic Cancer Center, University of Minnesota

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Improving Childhood Cancer Survivor Care Through Web-Based Platforms. [2018]

2. United States 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

A systematic review of smartphone applications for cancer survivors. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Acceptance and Use of eHealth/mHealth Applications for Self-Management Among Cancer Survivors. [2018]

5. Canada 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. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

HPV vaccination coverage for pediatric, adolescent and young adult patients receiving care in a childhood cancer survivor program. [2022]

7. United States 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. [2019]

8. Italy pubmed.ncbi.nlm.nih.gov

[Active surveillance evaluation of anti-HPV vaccine adverse events in Umbria region]. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Human Papillomavirus Vaccination Rates in Young Cancer Survivors. [2023]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Human papillomavirus vaccination and the primary prevention of cancer: implications for survivors of childhood cancer. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Human papillomavirus vaccination in survivors of childhood cancer. [2021]

12. Germany pubmed.ncbi.nlm.nih.gov

Position paper--HPV and the primary prevention of cancer; improving vaccine uptake by paediatricians. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Missed opportunities for concomitant HPV vaccination among childhood cancer survivors. [2022]