Human Papillomavirus (HPV) Vaccination Among Survivors of Childhood Cancer

NCT01117389 | Completed DMC

• 1 other identifier: HPV1
• Study Type: observational
• Target: 587
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Papillomavirus

Keywords

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

Outcome Measures

Primary Outcomes (2)

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

  1 year

• To describe the difference in HPV vaccination rate and HPV vaccination intent among preadolescent/adolescent females surviving childhood cancer and an acquaintance control group.

  1 year

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 9 Years - 26 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Maternal participants and young adult females (18-26) enrolled from the ACT clinic will provide contact information for acquaintances in their communities who have daughters (in the young adult arm 18-26 years old peers) roughly the same age as the targeted ACT patient. This will obtain a control sample demographically most like the cancer group. Typically, this will take the form of having the participants access their cell phones, and provide the contact information of the mothers (or 18-26 year old peers) who they identify as potential acquaintance controls. This information will then be used as a means to contact the potential acquaintance control participants. These participants will be mothers with daughters between the ages of 9 and 17 years-of-age or 18-26 year old females. Participants aged 18-26 years will now complete self-reported questionnaires as part of this survey study.

You may qualify if:

• 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).
• Proficient in reading and writing English.
• Cognitively intact such that the study questionnaire can be understood and completed.
• 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.
• 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
• Proficient in reading and writing English
• Cognitively intact such that the study questionnaire can be understood and completed.
• 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.

You may not qualify if:

• \*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)

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead
• University of Memphis: collaborator

Study Sites (1)

St . Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Communicable Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• James Klosky, Ph.D

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2010
• First Posted: May 5, 2010
• Study Start: May 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: August 27, 2015

Record last verified: 2013-08

Locations

US (1)