이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Human Papillomavirus (HPV) Vaccination Among Survivors of Childhood Cancer

2015년 8월 26일 업데이트: St. Jude Children's Research Hospital

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.

연구 개요

상태

완전한

상세 설명

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.

연구 유형

관찰

등록 (실제)

587

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Tennessee
      • Memphis, Tennessee, 미국, 38105
        • St . Jude Children's Research Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

9년 (어린이, 성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

여성

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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 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.

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
To estimate the prevalence of HPV vaccination among a large cohort of childhood cancer survivors and an acquaintance control group.
기간: 1 year
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.
기간: 1 year
1 year

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: James Klosky, Ph.D, St. Jude Children's Research Hospital

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2010년 5월 1일

기본 완료 (실제)

2012년 11월 1일

연구 완료 (실제)

2012년 11월 1일

연구 등록 날짜

최초 제출

2010년 4월 30일

QC 기준을 충족하는 최초 제출

2010년 5월 4일

처음 게시됨 (추정)

2010년 5월 5일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2015년 8월 27일

QC 기준을 충족하는 마지막 업데이트 제출

2015년 8월 26일

마지막으로 확인됨

2013년 8월 1일

추가 정보

이 연구와 관련된 용어

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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