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Tracking Information | |||||
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First Received Date † | December 11, 2008 | ||||
Last Updated Date | December 11, 2008 | ||||
Start Date † | January 2009 | ||||
Current Primary Outcome Measures † | |||||
Original Primary Outcome Measures † | |||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | Health Care Decisions for Female Adolescents: The Role of Mothers and Daughters in Decision Making | ||||
Official Title † | Health Care Decisions for Female Adolescents: The Role of Mothers and Daughters in Decision Making | ||||
Brief Summary | Preventing cervical cancer is a public health concern. Since 2006 a quadrivalent vaccine for young women nine to twenty six years of age has been available to protect against the human papillomavirus (HPV) and to prevent some types of cervical cancer (Gardasil). The vaccine is an important health promotion tool to address the widespread prevalence of HPV and cervical cancer, but not all eligible young women receive the vaccine. The vaccine is most effective when administered to young women before their sexual debut. When the vaccine is given to young women less than 18 years of age, parental permission is required. This permission is usually provided by the young woman's mother. Understanding predictors of a mother's decision for her minor daughter to receive the HPV vaccine will inform interventions that seek to increase the number of young women who receive the vaccine. The study will focus on mothers and their adolescent daughters between 13-17 years of age. We hypothesize that the Expanded Theory of Planned Behavior will explain a mother's decision to choose the HPV vaccine for her daughter. Research Questions include: 1)What TPB variables predict a mother's decision to choose HPV vaccine for her daughter? 2)What variables predict the strength of a daughter's influence on the mother's decision to choose HPV vaccine for her daughter? 3) What are the relationships between the mothers' and daughters' scores on the variables related to the decision to choose HPV vaccine? 4) How do the mothers and daughters who chose to receive the HPV vaccine differ descriptively from those mothers and daughters who do not choose to receive the HPV vaccine? |
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Detailed Description | Preventing cervical cancer is a public health concern. Since 2006 a quadrivalent vaccine for young women nine to twenty six years of age has been available to protect against the human papillomavirus (HPV) and to prevent some types of cervical cancer (Gardasil). The vaccine is an important health promotion tool to address the widespread prevalence of HPV and cervical cancer, but not all eligible young women receive the vaccine. The vaccine is most effective when administered to young women before their sexual debut. When the vaccine is given to young women less than 18 years of age, parental permission is required. This permission is usually provided by the young woman's mother. Understanding predictors of a mother's decision for her minor daughter to receive the HPV vaccine will inform interventions that seek to increase the number of young women who receive the vaccine. Health behavior theories, such as the Theory of Planned Behavior (TPB), indicate the factors and mechanisms that predict health promotion decisions and activities. TPB provides a direct statistical model through which variables related to health behaviors can be measured and evaluated, and will be used to guide the proposed study. The study will focus on mothers and their adolescent daughters between 13-17 years of age. The normative changes and realignments in the parent child relationship that arrive with the onset of adolescence, coincide with greater adolescence behavioral autonomy, and influence over parental decisions related to the adolescent. Thus, we expanded the TPB to include the influence of the adolescent on the mother's decision for her daughter to receive the HPV vaccine. Hypothesis: We hypothesize that the Expanded Theory of Planned Behavior will explain a mother's decision to choose the HPV vaccine for her daughter. Research Questions: RSQ1: What TPB variables predict a mother's decision to choose HPV vaccine for her daughter? RSQ2: What variables predict the strength of a daughter's influence on the mother's decision to choose HPV vaccine for her daughter? RSQ3: What are the relationships between the mothers' and daughters' scores on the variables related to the decision to choose HPV vaccine? RSQ4: How do the mothers and daughters who chose to receive the HPV vaccine differ descriptively from those mothers and daughters who do not choose to receive the HPV vaccine? Data will be analyzed using path analysis, multiple regression, and analysis of variance. The model demonstrates multiple potential influences on the mother's decision to choose the HPV vaccine for her daughter, and all influences are potential targets for family teaching interventions and tailored social marketing. Further study will be needed to determine how well the model applies to various family types and diverse cultures and nationalities. |
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Study Phase | |||||
Study Type † | Observational | ||||
Study Design † | Case-Only, Cross-Sectional | ||||
Condition † | Cervical Cancer | ||||
Intervention † | |||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Not yet recruiting | ||||
Enrollment † | 150 | ||||
Estimated Completion Date | December 2009 | ||||
Estimated Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Female | ||||
Ages | 13 Years and older | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts †† |
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Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00807898 | ||||
Responsible Party | Mimia Cynthia Logsdon, DNS, ARNP, FAAN, Professor, Principal Investigator, University of Louisville School of Nursing | ||||
Secondary IDs †† | Merck33563 | ||||
Study Sponsor † | University of Louisville | ||||
Collaborators †† | Merck | ||||
Investigators † |
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Information Provided By | University of Louisville | ||||
Verification Date | December 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |