Human Papillomavirus (HPV) Vaccination Among Survivors of Childhood Cancer

NCT ID: NCT01117389

Last Updated: 2015-08-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 587 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2012-11-30

Brief Summary

This study will focus on the primary objectives:

• To estimate the prevalence of HPV vaccination among a large cohort of childhood cancer survivors and an acquaintance control group.
• To describe the difference in HPV vaccination rate and HPV vaccination intent among preadolescent/adolescent females surviving childhood cancer and an acquaintance control group.

This study will also focus on the secondary objectives:

• To examine sociodemographic, medical, and psychological differences between those who have/have not initiated HPV vaccination and between those who do/do not intend to get vaccinated in the future.
• To assess the general predictive influence of sociodemographic, medical, and psychological variables on HPV vaccination and intent among mothers with preadolescent/adolescent daughters.

Detailed Description

Effective vaccination is now available to prevent human papillomavirus (HPV), the most common sexually transmitted infection and the cause of cervical cancer, the second most common cancer among women worldwide. HPV vaccine uptake is particularly important for females surviving childhood cancer, many of whom are at high risk for HPV complications due to the direct and indirect effects of cancer treatment. Thus, Version 3.0 of the Children's Oncology Group Long-Term Follow-Up Guidelines for Survivors of Childhood, Adolescent and Young Adult Cancer has recently recommended HPV vaccination for all eligible females surviving childhood cancer. Because this vaccine was only FDA approved in 2006, little is known about the complexity of vaccination uptake among those surviving cancer, and how the factors influencing vaccination decision-making differ among families with and without a history of pediatric cancer.

The purpose of this exploratory study is to estimate the prevalence of HPV vaccination and to assess predictors of HPV vaccination (and intent) among 9-26 year old females who have survived childhood cancer, while making comparisons to healthy acquaintance controls. In a cross-sectional design, those surviving childhood cancer (and acquaintance controls) will be asked to complete a questionnaire which queries sociodemographic, medical, and psychological variables which may relate to HPV vaccination or intent. Current vaccination rates will be examined and factors which associate with HPV vaccination (and intent) will be identified. Findings of the present study will inform recruitment strategies for future studies examining the immunogenicity, safety, tolerability, and behavioral outcomes of HPV vaccination among females surviving childhood cancer. More immediately, this work will further our understanding of familial decision-making regarding HPV vaccination among female survivors of childhood cancer and will determine whether vaccination recruitment models developed for healthy adolescents and young adults generalize to the pediatric cancer population.

Conditions

Human Papillomavirus

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Mothers of Childhood cancer survivors

Mothers or female primary caregivers of active patients (aged 9-17) and young adult female patients aged 18-26 in the After Completion of Therapy (ACT) clinic at SJCRH. Mothers or female primary caregivers of active patients (aged 9-17) and young adult female patients aged 18-26 in the ACT clinic surviving childhood cancer will be asked to complete a questionnaire which queries sociodemographic, medical, and psychological variables which may relate to HPV vaccination.

No interventions assigned to this group

Acquaintance control Group

Mothers or female primary caregivers ( with daughters aged 9-17) and young adult females aged 18-26 referred for study participation by participants from the ACT clinic. Participants have daughters aged 9-17 years or young adult females aged 18-26 at the time of study enrollment For those acquaintance controls electing to complete the paper-and-pencil questionnaire, the study team will send it to them in the mail along with a pre-addressed, stamped, return envelope. For those electing to complete the on-line questionnaire, the participant's email address will be collected and a secured link to our on-line questionnaire will be sent to them in an email.

A supplemental community control sample (meeting the inclusion and exclusion criteria outlined above) will also be utilized via the subject pool in the Department of Psychology at The University of Memphis.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Active females patients (aged 18-26 years) or mothers/female primary caregivers of minor female patients (aged 9-17 years) in the After Completion of Therapy (ACT) clinic at St. Jude Children's Research Hospital (SJCRH).

2. Proficient in reading and writing English.

3. Cognitively intact such that the study questionnaire can be understood and completed.

4. Participant is willing and able to provide informed consent according to institutional guidelines.

An acquaintance control sample will be comprised of a community sample of adult women (aged 18-26 years) and mothers with daughters in the 9-17 year age range who are acquainted with the ACT patient's family.The primary feature distinguishing the acquaintance controls from the SJCRH sample is the presence/nonpresence of personal (for controls aged 18-26) or daughter's (for maternal controls) cancer history.

1. Females (aged 18-26 years) or mothers/female primary caregivers (with daughters aged 9-17 years) referred for study participation by adult survivors or maternal participants from the ACT clinic

2. Proficient in reading and writing English

3. Cognitively intact such that the study questionnaire can be understood and completed.

4. Participant is willing and able to provide informed consent according to institutional guidelines.

According to institutional and NIH policy, the study will approach and consent research participants regardless of ethnic background.Institutional experience confirms broad representation in this regard.

Exclusion Criteria

*Personal history of cancer (for controls aged 18-26 years) or history of having a child diagnosed with cancer (for maternal controls with daughters aged 9-17 years)

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Memphis

OTHER

Sponsor Role: collaborator

St. Jude Children's Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Klosky, Ph.D

Role: PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Locations

St . Jude Children's Research Hospital

Memphis, Tennessee, United States

Countries

United States

Related Links

http://www.stjude.org

St. Jude Children's Research Hospital

Other Identifiers

HPV1

Identifier Type: -

Identifier Source: org_study_id