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Human Papillomavirus (HPV) Vaccination Among Survivors of Childhood Cancer


N/A
9 Years
26 Years
Open (Enrolling)
Female
Human Papillomavirus

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Trial Information

Human Papillomavirus (HPV) Vaccination Among Survivors of Childhood Cancer


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.

Inclusion Criteria


Inclusion Criteria- Mothers of ACT patients

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 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.

Inclusion criteria for acquaintance control participants:

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.

The following represents the inclusion criteria for acquaintance control participants:

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 for acquaintance control group

*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)

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.

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Cross-Sectional

Outcome Measure:

To estimate the prevalence of HPV vaccination among a large cohort of childhood cancer survivors and an acquaintance control group.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

James Klosky, Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Institutional Review Board

Study ID:

HPV1

NCT ID:

NCT01117389

Start Date:

May 2010

Completion Date:

November 2012

Related Keywords:

  • Human Papillomavirus
  • Human Papillomavirus Vaccination
  • Childhood cancer survivors
  • cervical cancer
  • sexually transmitted infection

Name

Location

St . Jude Children's Research HospitalMemphis, Tennessee  38105