Skin CancerPhase 2NCT01464957
Skin Cancer Prevention in a Pediatric Population
A Phase 2 study testing Semi-tailored newsletter in people with Skin Cancer, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Skin cancer risk is largely determined by sun exposure during childhood. This study determines the effectiveness of a mailed intervention designed to increase sun protection for children age 6-9 years old. The intervention includes newsletters for parents that include risk information tailored to each child. Read more about this study
- Who is it for?
- Ages 5 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Cancer
- What is being tested?
- Semi-tailored newsletter
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 867 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2003to Sep 2008
- Phase
- Phase 2
- 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 5 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child born in 1998, has resided in the Denver, Colorado area
Who cannot join
- Parents unable to respond to telephone survey; child has disabling condition
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
Skin cancer risk is largely determined by sun exposure during childhood. This study determines the effectiveness of a mailed intervention designed to increase sun protection for children age 6-9 years old. The intervention includes newsletters for parents that include risk information tailored to each child. Also included are sun protection resources such as a swim shirt, a sun hat, and sunscreen. Participants receive the intervention over 3 consecutive years, and data collection includes telephone interviews and skin exams. The study hypothesis is that receipt of the intervention will result in improved sun protection of the child.
Read the detailed description
About 1 in 90 American children born in the late 1990's will develop malignant melanoma in their lifetimes. Sun exposure in childhood appears to be the most important preventable risk factor for this disease. This project will develop a tailored, risk-based, written intervention, which will be mailed to parents of children age 6-9 years in the spring of each year. The tailored intervention will utilize the Precaution Adoption Process Model, which has a primary focus on risk perception and suggests that there are seven stages leading to sustained health behavior change. The effectiveness of the intervention will be tested using a randomized controlled trail involving 1000 children recruited from health care facilities and community locations at age 5-6 years and followed for 3 years using telephone interviews to assess sun protection behaviors and skin exams to observe changes in melanocytic nevi, freckling, and tanning.
- Conditions
- Skin Cancer
- Being tested
- Semi-tailored newsletter
- Keywords
- skin cancer prevention, precaution adoption process model, semi-tailored newsletter, pediatric, behavioral intervention
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-tailored newsletterBehavioural
Also called Semi-tailored newsletter intervention, for parents and children
Delivered over 3 consecutive years, in the spring
| Study group | Role | What they receive |
|---|---|---|
| Newsletter intervention | Experimental | Semi-tailored newsletter intervention for parents and children Receives: Behavioral: Semi-tailored newsletter |
| Usual care | No intervention | No newsletter intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
sun protection behavior scale
Parent report through telephone interview
Measured: change from baseline over 4 years
Secondary outcomes (1)
Nevus counts
Health care provider skin examination of nevi by size and body location
Measured: Change from baseline over 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2011 (estimated)
- Study startNov 2003
- Primary completionSep 2007
- Study completionSep 2008
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 Skin CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 867 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Kaiser Permanente, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lori A Crane, PhD, MPH, Principal investigator, University of Colorado, DenverJoseph Morelli, MD, Principal investigator, University of Colorado, DenverStefan T Morelli, MD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01464957
- Sponsor's protocol ID
- 96-0014
- Other IDs
- R01CA074592
- Status last verified
- Jan 2013
- First submitted
- 14 Aug 2011
- Last updated
- 25 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Crane LA, Asdigian NL, Baron AE, Aalborg J, Marcus AC, Mokrohisky ST, Byers TE, Dellavalle RP, Morelli JG. Mailed intervention to promote sun protection of children: a randomized controlled trial. Am J Prev Med. 2012 Oct;43(4):399-410. doi: 10.1016/j.amepre.2012.06.022.
PubMed 22992358
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Cancer Prevention in a Pediatric Population
- ClinicalTrials.gov ID
- NCT01464957
- Acronym / sponsor ID
- 96-0014
- Conditions
- Skin Cancer
- Keywords
- skin cancer prevention, precaution adoption process model, semi-tailored newsletter, pediatric, behavioral intervention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 867 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Kaiser Permanente, National Cancer Institute (NCI)
- Study start
- Nov 2003
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 4 Nov 2011 (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.
Skin cancer risk is largely determined by sun exposure during childhood. This study determines the effectiveness of a mailed intervention designed to increase sun protection for children age 6-9 years old. The intervention includes newsletters for parents that include risk information tailored to each child. Also included are sun protection resources such as a swim shirt, a sun hat, and sunscreen. Participants receive the intervention over 3 consecutive years, and data collection includes telephone interviews and skin exams. The study hypothesis is that receipt of the intervention will result in improved sun protection of the child.
Detailed description
About 1 in 90 American children born in the late 1990's will develop malignant melanoma in their lifetimes. Sun exposure in childhood appears to be the most important preventable risk factor for this disease. This project will develop a tailored, risk-based, written intervention, which will be mailed to parents of children age 6-9 years in the spring of each year. The tailored intervention will utilize the Precaution Adoption Process Model, which has a primary focus on risk perception and suggests that there are seven stages leading to sustained health behavior change. The effectiveness of the intervention will be tested using a randomized controlled trail involving 1000 children recruited from health care facilities and community locations at age 5-6 years and followed for 3 years using telephone interviews to assess sun protection behaviors and skin exams to observe changes in melanocytic nevi, freckling, and tanning.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Newsletter intervention | Experimental | Behavioral: Semi-tailored newsletterSemi-tailored newsletter intervention for parents and children |
| Usual care | No intervention | –No newsletter intervention |
Who may qualify
- Ages
- 5 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Child born in 1998, has resided in the Denver, Colorado area
Key exclusion criteria (1 listed)
- Parents unable to respond to telephone survey; child has disabling condition
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 |
|---|---|---|
| Semi-tailored newsletterAlso: Semi-tailored newsletter intervention, for parents and childrenDelivered over 3 consecutive years, in the spring | Behavioural | Newsletter intervention |
Primary outcome
sun protection behavior scale
Time frame: change from baseline over 4 years
Parent report through telephone interview
1 secondary outcome
Nevus counts
Time frame: Change from baseline over 4 years
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 25 Jan 2013.
- Derived from this study: PubMed 22992358Crane LA, Asdigian NL, Baron AE, Aalborg J, Marcus AC, Mokrohisky ST, Byers TE, Dellavalle RP, Morelli JG. Mailed intervention to promote sun protection of children: a randomized controlled trial. Am J Prev Med. 2012 Oct;43(4):399-410. doi: 10.1016/j.amepre.2012.06.022.
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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.
Lori A Crane, PhD, MPH principal investigator
University of Colorado, Denver
Joseph Morelli, MD principal investigator
University of Colorado, Denver
Stefan T Morelli, MD principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Semi-tailored newsletter in people with Skin Cancer, run by University of Colorado, Denver 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 1 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 25 Jan 2013. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
sun protection behavior scale (time frame: change from baseline over 4 years). 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 NCT01464957, 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 25 Jan 2013.