Skin CancerNCT00346021
Sun Protection for Florida's Children
A study testing Increasing hat use in people with Skin Cancer, run by University of South Florida at 1 site in United States.
Trial summary
Purpose of the project is to develop a school-based intervention aimed at increasing hat use when children are outside at home and at school. The intervention is targeted to fourth grade children in Hillsborough County, Florida and is based on Theory of Reasoned Action and Planned Behavior. Read more about this study
- Who is it for?
- Ages 8 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Cancer
- What is being tested?
- Increasing hat use
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,984 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Aug 2011
- Phase
- Interventional
- 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 8 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- One fourth/one fifth grade class.
- 20 students minimum.
- 25% of students are Caucasian.
- Principle/teachers agree to participate.
- Majority of parents agree to participate.
- Majority of 4th grade students provide written assent.
Show all 11Show fewer
- One outdoor session lasting 20 minutes once per week where children are directly exposed to the sun.
- Outdoor session in an area observable by data monitors.
- School can accommodate intervention components of study.
- School environment stable over the intervention period.
- Randomized control school delay sun protection initiatives until project is completed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Purpose of the project is to develop a school-based intervention aimed at increasing hat use when children are outside at home and at school. The intervention is targeted to fourth grade children in Hillsborough County, Florida and is based on Theory of Reasoned Action and Planned Behavior. It is structured to accomplish the following goals: (a) increase sun protection knowledge of children in regards to hat use,(b) foster more positive attitudes in regard to wearing hats,(c) change the subjective norms of wearing hats (d) target persons that children perceive as controlling their behavior of wearing hats(parents,teachers) and increase the use of hats when children are outdoors at school(primary outcome) and when outdoors at times other than school(secondary outcome).
Read the detailed description
Intervention is aimed at encouraging students to use a wide brim hat when participating in outdoor activities. To accomplish this goal our approach will be multifaceted and will include:
- individual sessions with school principals to facilitate a school policy that encourages hat use when children are outdoors.
- sessions with fourth grade teachers that explains the importance of sun protection and hat use, and that addresses potential concerns by teachers.
- classroom sessions with fourth grade children that improves sun protection knowledge, fosters more positive attitudes about hat use. and that changes the subjective norm of wearing hats when at school.
- follow-up sessions in which children are provided free hats with a customized design that represents their school.
- sun protection educational materials that are mailed to the parents of targeted children.
- Conditions
- Skin Cancer
- Being tested
- Increasing hat use
- Keywords
- Children's behavior towards hat use
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Increasing hat useBehavioural
Sun protection intervention that address sun protection knowledge, attitudes, social norms, and perceived behavioral controls. Intervention also provides free wide brimmed hats
| Study group | Role | What they receive |
|---|---|---|
| Sun Protection Intervention | Experimental | School based sun protection education, provision of free hats. Receives: Behavioral: Increasing hat use |
| Control arm | No intervention | Usual sun protection practices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase the use of hats when children are outside at school
Measured: june 2008
Secondary outcomes (1)
Increase the hat use when children are outside at times other than school
Measured: june 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2006 (estimated)
- Study startFeb 2005
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,984 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Roetzheim, University of South Florida
- Investigators
- Richard G Roetzheim, MD, MSPH, Principal investigator, Department of Family Medicine, USF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00346021
- Sponsor's protocol ID
- R01CA103965-01
- Status last verified
- Jun 2012
- First submitted
- 27 Jun 2006
- Last updated
- 20 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Roetzheim RG, Love-Jackson KM, Hunter SG, Lee JH, Chen R, Abdulla R, Wells KJ. A cluster randomized trial of sun protection at elementary schools. Results from year 2. Am J Prev Med. 2011 Dec;41(6):615-8. doi: 10.1016/j.amepre.2011.08.005.
PubMed 22099239Hunter S, Wells KJ, Jacobsen PB, Lee JH, Boulware D, Love-Jackson K, Abdulla R, Roetzheim RG. Assessment of elementary school students' sun protection behaviors. Pediatr Dermatol. 2010 Mar-Apr;27(2):182-8. doi: 10.1111/j.1525-1470.2009.00940.x. Epub 2009 Jul 20.
PubMed 19686304
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sun Protection for Florida's Children
- ClinicalTrials.gov ID
- NCT00346021
- Acronym / sponsor ID
- R01CA103965-01
- Conditions
- Skin Cancer
- Keywords
- Children's behavior towards hat use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,984 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- Feb 2005
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 29 Jun 2006 (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.
Purpose of the project is to develop a school-based intervention aimed at increasing hat use when children are outside at home and at school. The intervention is targeted to fourth grade children in Hillsborough County, Florida and is based on Theory of Reasoned Action and Planned Behavior. It is structured to accomplish the following goals: (a) increase sun protection knowledge of children in regards to hat use,(b) foster more positive attitudes in regard to wearing hats,(c) change the subjective norms of wearing hats (d) target persons that children perceive as controlling their behavior of wearing hats(parents,teachers) and increase the use of hats when children are outdoors at school(primary outcome) and when outdoors at times other than school(secondary outcome).
Detailed description
Intervention is aimed at encouraging students to use a wide brim hat when participating in outdoor activities. To accomplish this goal our approach will be multifaceted and will include:
- individual sessions with school principals to facilitate a school policy that encourages hat use when children are outdoors.
- sessions with fourth grade teachers that explains the importance of sun protection and hat use, and that addresses potential concerns by teachers.
- classroom sessions with fourth grade children that improves sun protection knowledge, fosters more positive attitudes about hat use. and that changes the subjective norm of wearing hats when at school.
- follow-up sessions in which children are provided free hats with a customized design that represents their school.
- sun protection educational materials that are mailed to the parents of targeted children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sun Protection Intervention | Experimental | Behavioral: Increasing hat useSchool based sun protection education, provision of free hats. |
| Control arm | No intervention | –Usual sun protection practices |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- One fourth/one fifth grade class.
- 20 students minimum.
- 25% of students are Caucasian.
- Principle/teachers agree to participate.
- Majority of parents agree to participate.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Increasing hat useSun protection intervention that address sun protection knowledge, attitudes, social norms, and perceived behavioral controls. Intervention also provides free wide brimmed hats | Behavioural | Sun Protection Intervention |
Primary outcome
Increase the use of hats when children are outside at school
Time frame: june 2008
1 secondary outcome
Increase the hat use when children are outside at times other than school
Time frame: june 2008
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 20 Jun 2012.
- Derived from this study: PubMed 22099239Roetzheim RG, Love-Jackson KM, Hunter SG, Lee JH, Chen R, Abdulla R, Wells KJ. A cluster randomized trial of sun protection at elementary schools. Results from year 2. Am J Prev Med. 2011 Dec;41(6):615-8. doi: 10.1016/j.amepre.2011.08.005.
- Derived from this study: PubMed 19686304Hunter S, Wells KJ, Jacobsen PB, Lee JH, Boulware D, Love-Jackson K, Abdulla R, Roetzheim RG. Assessment of elementary school students' sun protection behaviors. Pediatr Dermatol. 2010 Mar-Apr;27(2):182-8. doi: 10.1111/j.1525-1470.2009.00940.x. Epub 2009 Jul 20.
- Information on the Sun protection ProjectLink provided by the sponsor.
Related trials for Skin Cancer
Enrolling by invitation
Exercise Intervention for Breast Cancer Patients With Sarcopenia
Sarcopenia, Breast Cancer
RecruitingPhase 2
A Clinical Study on Prophylactic RespOnse To hEtrombopag for Secondary Prevention in Anti-Cancer Therapy-induced Thrombocytopeniae
Breast Cancer Patients at High Risk of Chemotherapy-induced Thrombocytopenia (CTIT)
Not yet recruitingPhase 2
Trastuzumab Deruxtecan and Lovastatin in HER2-low and Ultralow Advanced or Metastatic Breast Cancer
Breast Cancer, Advanced Breast Cancer
RecruitingObservational study
Audit of Targeted Sentinel Node Biopsy (TSNB) in Patients With Limited Nodal Disease Undergoing Primary Surgery
Breast Cancer, Axillary Lymph Nodes Dissection
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
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.
Richard G Roetzheim, MD, MSPH principal investigator
Department of Family Medicine, USF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Increasing hat use in people with Skin Cancer, run by University of South Florida 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 1 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 20 Jun 2012. 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?
Increase the use of hats when children are outside at school (time frame: june 2008). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00346021, which also lists 2 linked publications.
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 20 Jun 2012.