Cancer PreventionEarly Phase 1NCT02426853
Ultraviolet (UV) Photography in Adolescents
A Early Phase 1 study testing Questionnaires, Photos and Pamphlets in people with Cancer Prevention, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this research study is to learn how students react to seeing a photograph of any skin damage they may have on their face. This skin damage may be caused by sun exposure or use of tanning beds. Read more about this study
- Who is it for?
- Ages 12 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer Prevention
- What is being tested?
- Questionnaires, Photos and Pamphlets
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 293 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2015to 14 Sep 2020
- Phase
- Early Phase 1
- 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 12 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Enrolled in 7th or 8th grade
- Ability to speak, read and write English
- Has email address and internet access to complete online surveys
- Willingness to provide contact information including phone number, email address and mailing address
Who cannot join
- 1) N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
Houston Independent School District
Houston, Texas, 77092
About this study
Official title: Sun Protection, Tanning Behaviors and Attitudes in Adolescents
The goal of this research study is to learn how students react to seeing a photograph of any skin damage they may have on their face. This skin damage may be caused by sun exposure or use of tanning beds. Researchers also want to learn about students' sun protection, tanning behaviors, and attitudes towards sun exposure, sun protection, tanning behaviors and skin cancer.
Researchers will use the results of this study to design programs for students about sun protection and tanning avoidance.
Read the detailed description
If participant agrees to take part in this study, they will complete 3 questionnaires about sun protection, tanning behaviors, sunburns, and attitudes and opinions about sun exposure, sun protection, tanning behaviors and skin cancer.
Participant's school will be assigned to 1 of 2 possible groups:
- If participant's school is assigned to Group 1, they will have 2 photos taken of their face. One (1) photo is a standard photo (like the kind one may take with a regular camera). The other photo is taken with an ultraviolet (UV) filter and shows skin damage that cannot be seen in a standard photo.
- If participant's school is assigned to Group 2, they will not have any photos taken.
If participant is in Group 1, they and a member of the study staff will compare the standard and UV photographs together. The study staff will discuss any skin damage seen with participant. A member of the study staff will record on a paper form any visible reactions participant may have to viewing their UV photograph. Participant will also be given a handout that discusses skin cancer prevention, sun protection, and how to avoid tanning beds. Participant will see their photos on a computer screen. Participant will not be given their photos. At the end of this study, the photos will be deleted.
If participant is in Group 2, they will only receive a handout that discusses skin cancer prevention, sun protection, and how to avoid tanning beds.
All participants will complete 1 questionnaire at the beginning of the study (before receiving any kind of education about skin cancer prevention), 1 questionnaire after receiving education about how to protect participant's skin from the sun and how to avoid tanning beds, and 1 questionnaire at about 3 months after receiving the education about how to protect skin from the sun and how to avoid tanning beds.
Participant will complete these study procedures at school and they may answer some of the questionnaires outside of school. Participant will complete the first questionnaire on paper at their school. Participant will have an option to complete this questionnaire online if they are not able to complete it on paper the day the study team visits their school. Participant will complete the second questionnaire on paper at their school. Participant will complete the third questionnaire online. Links to the online questionnaires will be sent to the email address that participant will provide on the Participant Contact Information Form. Participant will also have an option to receive a link to the questionnaire via text message if they provide us with a cell phone number that can receive text messages on the Participant Contact Information Form. Participant may incur charges for receiving text messages.
Length of Study:
Student's participation in this study will be over after they have completed the last questionnaire. It will take about 1 hour to complete all study questionnaires and procedures.
This is an investigational study.
Up to 420 participants will be enrolled in this study. All will take part through MD Anderson at different schools in the greater Houston area.
Only about 35 participants will be able to take part at each school. This means that even if participant agrees, they may not be selected to take part in this study. The student participants will be randomly selected from the pool of students who agree to participate.
- Conditions
- Cancer Prevention
- Being tested
- Questionnaires, Photos, Pamphlets
- Keywords
- Cancer Prevention, Sun protection, Photograph, UV photograph, Ultraviolet, Pamphlets, Handouts, Questionnaires, Surveys, Skin cancer risk behaviors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesBehavioural
Also called Surveys
Participants complete 1 questionnaire at beginning of study, 1 after receiving education about how to protect skin from sun and how to avoid tanning beds, and 1 at about 3 months after receiving skin protection education.
PhotosOther
Also called Pictures
At beginning of study, 2 photos taken of the face. One photo is a standard photo, the other photo is taken with an ultraviolet (UV) filter.
PamphletsBehavioural
Also called Handouts
At beginning of study, handouts given that discusses skin cancer prevention, sun protection, and how to avoid tanning beds.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - UV Photography Group | Experimental | Participants complete 1 questionnaire at beginning of study, 1 after receiving education about how to protect skin from sun and how to avoid tanning beds, and 1 at about 3 months after receiving skin protection education. Participants given handouts that discusses skin cancer prevention, sun protection, and how to avoid tanning beds. At beginning of study, 2 photos taken of the face. One photo is a standard photo, the other photo is taken with an ultraviolet (UV) filter. Receives: Behavioral: Questionnaires; Other: Photos; Behavioral: Pamphlets |
| Group 2 - Comparison Group | Active comparator | Participants complete 1 questionnaire at beginning of study, 1 after receiving education about how to protect skin from sun and how to avoid tanning beds, and 1 at about 3 months after receiving skin protection education. Participants given handouts that discusses skin cancer prevention, sun protection, and how to avoid tanning beds. Receives: Behavioral: Questionnaires; Behavioral: Pamphlets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sun Protection Behavior Composite Score
Baseline sun protection behaviors are assessed using self-reported measures of sun protection behaviors. Both the baseline and 3-month behavior composite scores range from 1 to 5 and are calculated as the mean of the four sun protection behavior items.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2015 (estimated)
- Study start21 Apr 2015
- Primary completion14 Sep 2020
- Study completion14 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PreventionStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 293 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan Peterson, MPH,PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02426853
- Sponsor's protocol ID
- 2014-1037
- Other IDs
- NCI-2015-00764
- Status last verified
- Oct 2020
- First submitted
- 22 Apr 2015
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sun Protection, Tanning Behaviors and Attitudes in Adolescents
- ClinicalTrials.gov ID
- NCT02426853
- Acronym / sponsor ID
- 2014-1037
- Conditions
- Cancer Prevention
- Keywords
- Cancer Prevention, Sun protection, Photograph, UV photograph, Ultraviolet, Pamphlets, Handouts, Questionnaires
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 293 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 21 Apr 2015 (actual)
- Primary completion
- 14 Sep 2020 (actual)
- Study completion
- 14 Sep 2020 (actual)
- First posted
- 27 Apr 2015 (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.
The goal of this research study is to learn how students react to seeing a photograph of any skin damage they may have on their face. This skin damage may be caused by sun exposure or use of tanning beds. Researchers also want to learn about students' sun protection, tanning behaviors, and attitudes towards sun exposure, sun protection, tanning behaviors and skin cancer.
Researchers will use the results of this study to design programs for students about sun protection and tanning avoidance.
Detailed description
If participant agrees to take part in this study, they will complete 3 questionnaires about sun protection, tanning behaviors, sunburns, and attitudes and opinions about sun exposure, sun protection, tanning behaviors and skin cancer.
Participant's school will be assigned to 1 of 2 possible groups:
- If participant's school is assigned to Group 1, they will have 2 photos taken of their face. One (1) photo is a standard photo (like the kind one may take with a regular camera). The other photo is taken with an ultraviolet (UV) filter and shows skin damage that cannot be seen in a standard photo.
- If participant's school is assigned to Group 2, they will not have any photos taken.
If participant is in Group 1, they and a member of the study staff will compare the standard and UV photographs together. The study staff will discuss any skin damage seen with participant. A member of the study staff will record on a paper form any visible reactions participant may have to viewing their UV photograph. Participant will also be given a handout that discusses skin cancer prevention, sun protection, and how to avoid tanning beds. Participant will see their photos on a computer screen. Participant will not be given their photos. At the end of this study, the photos will be deleted.
If participant is in Group 2, they will only receive a handout that discusses skin cancer prevention, sun protection, and how to avoid tanning beds.
All participants will complete 1 questionnaire at the beginning of the study (before receiving any kind of education about skin cancer prevention), 1 questionnaire after receiving education about how to protect participant's skin from the sun and how to avoid tanning beds, and 1 questionnaire at about 3 months after receiving the education about how to protect skin from the sun and how to avoid tanning beds.
Participant will complete these study procedures at school and they may answer some of the questionnaires outside of school. Participant will complete the first questionnaire on paper at their school. Participant will have an option to complete this questionnaire online if they are not able to complete it on paper the day the study team visits their school. Participant will complete the second questionnaire on paper at their school. Participant will complete the third questionnaire online. Links to the online questionnaires will be sent to the email address that participant will provide on the Participant Contact Information Form. Participant will also have an option to receive a link to the questionnaire via text message if they provide us with a cell phone number that can receive text messages on the Participant Contact Information Form. Participant may incur charges for receiving text messages.
Length of Study:
Student's participation in this study will be over after they have completed the last questionnaire. It will take about 1 hour to complete all study questionnaires and procedures.
This is an investigational study.
Up to 420 participants will be enrolled in this study. All will take part through MD Anderson at different schools in the greater Houston area.
Only about 35 participants will be able to take part at each school. This means that even if participant agrees, they may not be selected to take part in this study. The student participants will be randomly selected from the pool of students who agree to participate.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - UV Photography Group | Experimental | Behavioral: Questionnaires, Other: Photos, Behavioral: PamphletsParticipants complete 1 questionnaire at beginning of study, 1 after receiving education about how to protect skin from sun and how to avoid tanning beds, and 1 at about 3 months after receiving skin protection education. Participants given handouts that discusses skin cancer prevention, sun protection, and how to avoid tanning beds. At beginning of study, 2 photos taken of the face. One photo is a standard photo, the other photo is taken with an ultraviolet (UV) filter. |
| Group 2 - Comparison Group | Active comparator | Behavioral: Questionnaires, Behavioral: PamphletsParticipants complete 1 questionnaire at beginning of study, 1 after receiving education about how to protect skin from sun and how to avoid tanning beds, and 1 at about 3 months after receiving skin protection education. Participants given handouts that discusses skin cancer prevention, sun protection, and how to avoid tanning beds. |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Enrolled in 7th or 8th grade
- Ability to speak, read and write English
- Has email address and internet access to complete online surveys
- Willingness to provide contact information including phone number, email address and mailing address
Key exclusion criteria (1 listed)
- 1) N/A
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 |
|---|---|---|
| QuestionnairesAlso: SurveysParticipants complete 1 questionnaire at beginning of study, 1 after receiving education about how to protect skin from sun and how to avoid tanning beds, and 1 at about 3 months after receiving skin protection education. | Behavioural | Group 1 - UV Photography Group, Group 2 - Comparison Group |
| PhotosAlso: PicturesAt beginning of study, 2 photos taken of the face. One photo is a standard photo, the other photo is taken with an ultraviolet (UV) filter. | Other | Group 1 - UV Photography Group |
| PamphletsAlso: HandoutsAt beginning of study, handouts given that discusses skin cancer prevention, sun protection, and how to avoid tanning beds. | Behavioural | Group 1 - UV Photography Group, Group 2 - Comparison Group |
Primary outcome
Sun Protection Behavior Composite Score
Time frame: 3 months
Baseline sun protection behaviors are assessed using self-reported measures of sun protection behaviors. Both the baseline and 3-month behavior composite scores range from 1 to 5 and are calculated as the mean of the four sun protection behavior items.
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 14 Oct 2020.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Susan Peterson, MPH,PHD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Questionnaires, Photos and Pamphlets in people with Cancer Prevention, run by M.D. Anderson Cancer Center 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 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 14 Oct 2020. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Composite Score (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2020.