Cervical CancerNCT00807898
Health Care Decisions for Female Adolescents: The Role of Mothers and Daughters in Decision Making
An observational study of Cervical Cancer, run by University of Louisville at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 13 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jan 2011
- 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 13 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Mother and daughter pairs (n =75) will be recruited.
Who may be able to join
- Adolescent females 13-17 years of age
- and adolescent's mother, any age
- and adolescent not pregnant
- and adolescent has not received vaccine for HPV
Who cannot join
- Males
- daughters younger than 13 yrs of age
- daughters older than 17 yrs of age
- pregnant daughters
- daughters who have received the HPV vaccine
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisville School of Nursing
Louisville, Kentucky, 40292
About this study
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?
Read the 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.
- Conditions
- Cervical Cancer
- Keywords
- Gardasil, HPV vaccine, decision making, mother, daughter
- Medical subject headings
- Uterine Cervical Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionDec 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Mimia Logsdon, University of Louisville
- Investigators
- Mimia C Logsdon, DNS, ARNP, FAAN, Principal investigator, University of Louisville School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00807898
- Sponsor's protocol ID
- OICB080587
- Other IDs
- Merck33563
- Status last verified
- Jan 2011
- First submitted
- 11 Dec 2008
- Last updated
- 5 May 2017
- Results posted
- No
Publications
Hertweck SP, LaJoie AS, Pinto MD, Flamini L, Lynch T, Logsdon MC. Health care decision making by mothers for their adolescent daughters regarding the quadrivalent HPV vaccine. J Pediatr Adolesc Gynecol. 2013 Apr;26(2):96-101. doi: 10.1016/j.jpag.2012.10.009.
PubMed 23518189
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Care Decisions for Female Adolescents: The Role of Mothers and Daughters in Decision Making
- ClinicalTrials.gov ID
- NCT00807898
- Acronym / sponsor ID
- OICB080587
- Conditions
- Cervical Cancer
- Keywords
- Gardasil, HPV vaccine, decision making, mother, daughter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jan 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 12 Dec 2008 (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.
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?
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 13 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Mother and daughter pairs (n =75) will be recruited.
Key inclusion criteria (4 listed)
- Adolescent females 13-17 years of age
- and adolescent's mother, any age
- and adolescent not pregnant
- and adolescent has not received vaccine for HPV
Key exclusion criteria (5 listed)
- Males
- daughters younger than 13 yrs of age
- daughters older than 17 yrs of age
- pregnant daughters
- daughters who have received the HPV vaccine
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
Not reported in the source record.
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 5 May 2017.
- Derived from this study: PubMed 23518189Hertweck SP, LaJoie AS, Pinto MD, Flamini L, Lynch T, Logsdon MC. Health care decision making by mothers for their adolescent daughters regarding the quadrivalent HPV vaccine. J Pediatr Adolesc Gynecol. 2013 Apr;26(2):96-101. doi: 10.1016/j.jpag.2012.10.009.
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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.
Mimia C Logsdon, DNS, ARNP, FAAN principal investigator
University of Louisville School of Nursing
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 Cervical Cancer, run by University of Louisville 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 4 inclusion and 5 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 5 May 2017. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00807898, which also lists 1 linked publication.
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 5 May 2017.