Skin NeoplasmsNCT03132012
Skin Health in Young Adults - Preventing Indoor Tanning and Promoting Sun Protection
A study testing Indoor tanning intervention in people with Skin Neoplasms, run by Yale University at 1 site in United States.
Trial summary
This is a pilot randomized controlled trial of an Internet-based skin cancer prevention intervention as compared to a standard of care control in 80 non-Hispanic white females ages 20-30. Read more about this study
- Who is it for?
- Ages 20 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Neoplasms
- What is being tested?
- Indoor tanning intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2017to 27 Feb 2018
- 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 20 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Tanned indoors in past 12 months
- Able to communicate well in English
- Reliable Internet access
Who cannot join
- History of skin cancer (self-report)
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale School of Public Health
New Haven, Connecticut, 06510
About this study
This is a pilot randomized controlled trial of an Internet-based skin cancer prevention intervention as compared to a standard of care control in 80 non-Hispanic white females ages 20-30.
- Conditions
- Skin Neoplasms
- Being tested
- Indoor tanning intervention, Standard of care control
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indoor tanning interventionBehavioural
6 Web-based modules that focus on preventing skin cancer through sun protection and indoor tanning reduction using the Theory of Planned Behavior and Prospect Theory
Standard of care controlBehavioural
One website with content similar to those available in dermatology offices on skin cancer prevention
| Study group | Role | What they receive |
|---|---|---|
| Indoor tanning intervention | Experimental | Web-based intervention modules to discourage tanning. Receives: Behavioral: Indoor tanning intervention |
| standard of care control | Active comparator | General information regarding UV protection measures through an online Qualtrics interface. Content will mirror information provided in brochures typically available in a dermatology office or through skin cancer prevention websites. Receives: Behavioral: Standard of care control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intention to indoor tan in next year
Indoor tanning intentions are measured on a scale that ranges from 1 (definitely do not intend to indoor tan) to 7 (definitely do intend to indoor tan).
Measured: Baseline
Intention to indoor tan in next year
Indoor tanning intentions are measured on a scale that ranges from 1 (definitely do not intend to indoor tan) to 7 (definitely do intend to indoor tan).
Measured: 12 Weeks First Follow-up
Intention to indoor tan in next year
Indoor tanning intentions are measured on a scale that ranges from 1 (definitely do not intend to indoor tan) to 7 (definitely do intend to indoor tan).
Measured: 24 Weeks Second Follow-up
Number of indoor tanning sessions in the previous 3 months
Self-report measure of number of times indoor tanned, reported retrospectively for the preceding 3 months.
Measured: 12 weeks preceding baseline
Number of indoor tanning sessions in the previous 3 months
Self-report measure of number of times indoor tanned, reported retrospectively for the preceding 3 months.
Measured: baseline to 12 Weeks (First Follow-up)
Number of indoor tanning sessions in the previous 3 months
Self-report measure of number of times indoor tanned, reported retrospectively for the preceding 3 months.
Measured: From 12 Weeks (first Follow-up) to 24 Weeks (Second Follow-up)
Secondary outcomes (6)
Intention to sunbathe outdoors in the next year
Sunbathing intentions are measured on a scale that ranges from 1 (definitely do not intend to indoor tan) to 7 (definitely do intend to indoor tan).
Measured: Baseline
Intention to sunbathe outdoors in the next year
Sunbathing intentions are measured on a scale that ranges from 1 (definitely do not intend to indoor tan) to 7 (definitely do intend to indoor tan).
Measured: 12 weeks First Follow-up
Intention to sunbathe outdoors in the next year
Sunbathing intentions are measured on a scale that ranges from 1 (definitely do not intend to indoor tan) to 7 (definitely do intend to indoor tan).
Measured: 24 weeks Second Follow-up
Number of outdoor sunbathing sessions in the previous 3 months
Self-report measure of number of times sunbathed, reported retrospectively for the preceding 3 months.
Measured: 12 weeks preceding baseline
Number of outdoor sunbathing sessions in the previous 3 months
Self-report measure of number of times sunbathed, reported retrospectively for the preceding 3 months.
Measured: baseline to 12 Weeks (First Follow-up)
Number of outdoor sunbathing sessions in the previous 3 months
Self-report measure of number of times sunbathed, reported retrospectively for the preceding 3 months.
Measured: From 12 Weeks (first Follow-up) to 24 Weeks (Second Follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start22 May 2017
- Primary completion27 Feb 2018
- Study completion27 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin NeoplasmsStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03132012
- Sponsor's protocol ID
- 1208010685
- Status last verified
- Jun 2018
- First submitted
- 20 Mar 2017
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Health in Young Adults - Preventing Indoor Tanning and Promoting Sun Protection
- ClinicalTrials.gov ID
- NCT03132012
- Acronym / sponsor ID
- 1208010685
- Conditions
- Skin Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 22 May 2017 (actual)
- Primary completion
- 27 Feb 2018 (actual)
- Study completion
- 27 Feb 2018 (actual)
- First posted
- 27 Apr 2017 (actual)
- 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.
This is a pilot randomized controlled trial of an Internet-based skin cancer prevention intervention as compared to a standard of care control in 80 non-Hispanic white females ages 20-30.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indoor tanning intervention | Experimental | Behavioral: Indoor tanning interventionWeb-based intervention modules to discourage tanning. |
| standard of care control | Active comparator | Behavioral: Standard of care controlGeneral information regarding UV protection measures through an online Qualtrics interface. Content will mirror information provided in brochures typically available in a dermatology office or through skin cancer prevention websites. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Tanned indoors in past 12 months
- Able to communicate well in English
- Reliable Internet access
Key exclusion criteria (1 listed)
- History of skin cancer (self-report)
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 |
|---|---|---|
| Indoor tanning intervention6 Web-based modules that focus on preventing skin cancer through sun protection and indoor tanning reduction using the Theory of Planned Behavior and Prospect Theory | Behavioural | Indoor tanning intervention |
| Standard of care controlOne website with content similar to those available in dermatology offices on skin cancer prevention | Behavioural | standard of care control |
Primary outcome
Intention to indoor tan in next year
Time frame: Baseline
Indoor tanning intentions are measured on a scale that ranges from 1 (definitely do not intend to indoor tan) to 7 (definitely do intend to indoor tan).
Intention to indoor tan in next year
Time frame: 12 Weeks First Follow-up
Indoor tanning intentions are measured on a scale that ranges from 1 (definitely do not intend to indoor tan) to 7 (definitely do intend to indoor tan).
Intention to indoor tan in next year
Time frame: 24 Weeks Second Follow-up
Indoor tanning intentions are measured on a scale that ranges from 1 (definitely do not intend to indoor tan) to 7 (definitely do intend to indoor tan).
Number of indoor tanning sessions in the previous 3 months
Time frame: 12 weeks preceding baseline
Self-report measure of number of times indoor tanned, reported retrospectively for the preceding 3 months.
Number of indoor tanning sessions in the previous 3 months
Time frame: baseline to 12 Weeks (First Follow-up)
Self-report measure of number of times indoor tanned, reported retrospectively for the preceding 3 months.
Number of indoor tanning sessions in the previous 3 months
Time frame: From 12 Weeks (first Follow-up) to 24 Weeks (Second Follow-up)
Self-report measure of number of times indoor tanned, reported retrospectively for the preceding 3 months.
6 secondary outcomes
Intention to sunbathe outdoors in the next year
Time frame: Baseline
Intention to sunbathe outdoors in the next year
Time frame: 12 weeks First Follow-up
Intention to sunbathe outdoors in the next year
Time frame: 24 weeks Second Follow-up
Number of outdoor sunbathing sessions in the previous 3 months
Time frame: 12 weeks preceding baseline
Number of outdoor sunbathing sessions in the previous 3 months
Time frame: baseline to 12 Weeks (First Follow-up)
Number of outdoor sunbathing sessions in the previous 3 months
Time frame: From 12 Weeks (first Follow-up) to 24 Weeks (Second Follow-up)
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 26 Jun 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Skin Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indoor tanning intervention in people with Skin Neoplasms, run by Yale University 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 3 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 26 Jun 2018. 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?
Intention to indoor tan in next year (time frame: Baseline). The study lists 6 primary outcomes in all. 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 26 Jun 2018.