Human PapillomavirusNCT01117389
Human Papillomavirus (HPV) Vaccination Among Survivors of Childhood Cancer
An observational study of Human Papillomavirus, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 26 years, women only
- Conditions the study is for
- Human Papillomavirus
- Type of treatment
- Vaccines
- How many people
- 587 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Nov 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 26 years
- Women only
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
- The following represents the inclusion criteria for acquaintance control participants:
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
St . Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
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.
Read more
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.
Read the 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
- Keywords
- Human Papillomavirus Vaccination, Childhood cancer survivors, cervical cancer, sexually transmitted infection
- Medical subject headings
- Uterine Cervical Neoplasms, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the prevalence of HPV vaccination among a large cohort of childhood cancer survivors and an acquaintance control group.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study startMay 2010
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human PapillomavirusStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 587 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Memphis
- Responsible party
- Sponsor
- Investigators
- James Klosky, Ph.D, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01117389
- Sponsor's protocol ID
- HPV1
- Status last verified
- Aug 2013
- First submitted
- 30 Apr 2010
- Last updated
- 27 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Papillomavirus (HPV) Vaccination Among Survivors of Childhood Cancer
- ClinicalTrials.gov ID
- NCT01117389
- Acronym / sponsor ID
- HPV1
- Conditions
- Human Papillomavirus
- Keywords
- Human Papillomavirus Vaccination, Childhood cancer survivors, cervical cancer, sexually transmitted infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 587 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Collaborators
- University of Memphis
- Study start
- May 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 5 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 9 to 26 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To estimate the prevalence of HPV vaccination among a large cohort of childhood cancer survivors and an acquaintance control group.
Time frame: 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.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2015.
- St. Jude Children's Research HospitalLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Klosky, Ph.D principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Papillomavirus, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To estimate the prevalence of HPV vaccination among a large cohort of childhood cancer survivors and an acquaintance control group. (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2015.