Skin NeoplasmsUV4meNCT02147080
A Tailored Internet Intervention to Reduce Skin Cancer Risk Behaviors Among Young Adults
A study testing UV4me and Skin Cancer Foundation website in people with Skin Neoplasms, run by Fox Chase Cancer Center at 1 site in United States.
Trial summary
Skin cancer is the most common cancer in the US, with over a million new cases diagnosed yearly. Young adults are increasingly at risk of melanoma. Contributing to the increasing skin cancer risk is the fact that US adolescents have the lowest skin protection rates of all age groups and also demonstrate increased… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Neoplasms
- What is being tested?
- UV4me and Skin Cancer Foundation website
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,234 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Oct 2014
- 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 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-25 years old
- Moderate to high risk of skin cancer (cut-off of >=27 on the Brief Skin Cancer Risk Assessment Tool)
Who cannot join
- History of skin cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Skin cancer is the most common cancer in the US, with over a million new cases diagnosed yearly. Young adults are increasingly at risk of melanoma. Contributing to the increasing skin cancer risk is the fact that US adolescents have the lowest skin protection rates of all age groups and also demonstrate increased exposure to natural and artificial UV radiation. Innovative interventions are needed to have an impact on skin cancer risk among young people. Unlike previous interventions, our skin cancer risk reduction intervention will be tailored (or personalized) to each individual participant and delivered via the Internet. The intervention will emphasize appearance concerns, which are known to be the primary motivation for UV exposure and lack of skin protection among young adults. This will be accomplished in part through the use of personalized facial images showing UV damage as well as computerized age progression demonstrations.
Primary Aim 1. To examine the efficacy of a tailored intervention delivered via the Internet designed to increase skin protection and decrease sun exposure behavior among young adults at moderate to high risk of developing skin cancer. Participants will be randomized to the tailored intervention, the Skin Cancer Foundation website, or an assessment only condition.
Read more
Aim 2. To evaluate whether sociodemographic variables (sex, race/ethnicity, skin type, family history of skin cancer), appearance consciousness, and past exposure and protective behaviors moderate intervention effects.
Aim 3. To evaluate whether Integrative Model constructs (UV-related knowledge, risk perception, beliefs, norms, self-efficacy, and intentions) mediate intervention effects.
The goals of future research would be to enhance the tailored intervention, for example, by adding additional contacts or Internet technologies or features, disseminate the intervention, assess the longevity of effects, and/or adapt the tailored intervention for use with other cancer risk behaviors or at risk groups.
- Conditions
- Skin Neoplasms
- Being tested
- UV4me, Skin Cancer Foundation website
- Keywords
- prevention or 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.
UV4meBehavioural
Also called Tailored Intervention for Skin Cancer Risk Reduction
Tailored website includes: personalized responses to quizzes, information on skin type and burn risk, UV damage photo of similar individual, avatar activity, age progression images, personal risk calculator, SPF (sun protection factor) calculator
Skin Cancer Foundation websiteBehavioural
Current best practice website for skin cancer and prevention. Includes information, images, news, and opportunities for advocacy.
| Study group | Role | What they receive |
|---|---|---|
| Tailored Intervention | Experimental | Subject has access to the tailored web intervention Receives: Behavioral: UV4me |
| Skin Cancer Foundation Website | Active comparator | Subject has access to the pre-existing Skin Cancer Foundation website Receives: Behavioral: Skin Cancer Foundation website |
| Assessment Only Condition | No intervention | Subjects will only complete assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sun protection
Continuous measure examining frequency of sun protection behaviors (e.g., sunscreen use, clothing, shade, sunglasses), using items adapted from Glanz and colleagues (2008)
Measured: Follow-up 1 (3 weeks after baseline)
Sun protection
Continuous measure examining frequency of sun protection behaviors (e.g., sunscreen use, clothing, shade, sunglasses), using items adapted from Glanz and colleagues (2008)
Measured: Follow-up 2 (12 weeks after baseline)
Outdoor UV Exposure
How many hours participants spend in the sun during peak daylight hours during the week
Measured: Follow-up 1 (3 weeks after baseline)
Outdoor UV exposure
How many hours participants spend in the sun during peak daylight hours during the week
Measured: Follow-up 2 (12 weeks after baseline)
Secondary outcomes (2)
Indoor Tanning
Number of indoor tanning sessions in past month
Measured: Follow-up 1 (3 weeks after baseline)
Indoor Tanning
Number of indoor tanning sessions in past month
Measured: Follow-up 2 (12 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2014 (estimated)
- Study startMar 2011
- Primary completionOct 2014
- Study completionOct 2014
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 NeoplasmsStudies of the same condition, open and under way.
- More trials run by Fox Chase 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
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Carolyn Heckman, Fox Chase Cancer Center
- Investigators
- Carolyn Heckman, Ph.D, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02147080
- Sponsor's protocol ID
- 1R01CA154928-01
- Other IDs
- 1R01CA154928
- Acronym
- UV4me
- Status last verified
- Jun 2018
- First submitted
- 22 May 2014
- Last updated
- 3 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Heckman CJ, Handorf EA, Darlow SD, Ritterband LM, Manne SL. An online skin cancer risk-reduction intervention for young adults: Mechanisms of effects. Health Psychol. 2017 Mar;36(3):215-225. doi: 10.1037/hea0000420. Epub 2016 Nov 7.
PubMed 27819460Heckman CJ, Darlow SD, Ritterband LM, Handorf EA, Manne SL. Efficacy of an Intervention to Alter Skin Cancer Risk Behaviors in Young Adults. Am J Prev Med. 2016 Jul;51(1):1-11. doi: 10.1016/j.amepre.2015.11.008. Epub 2016 Jan 22.
PubMed 26810358
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Tailored Internet Intervention to Reduce Skin Cancer Risk Behaviors Among Young Adults
- ClinicalTrials.gov ID
- NCT02147080
- Acronym / sponsor ID
- UV4me / 1R01CA154928-01
- Conditions
- Skin Neoplasms
- Keywords
- prevention or control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,234 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 26 May 2014 (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 is the most common cancer in the US, with over a million new cases diagnosed yearly. Young adults are increasingly at risk of melanoma. Contributing to the increasing skin cancer risk is the fact that US adolescents have the lowest skin protection rates of all age groups and also demonstrate increased exposure to natural and artificial UV radiation. Innovative interventions are needed to have an impact on skin cancer risk among young people. Unlike previous interventions, our skin cancer risk reduction intervention will be tailored (or personalized) to each individual participant and delivered via the Internet. The intervention will emphasize appearance concerns, which are known to be the primary motivation for UV exposure and lack of skin protection among young adults. This will be accomplished in part through the use of personalized facial images showing UV damage as well as computerized age progression demonstrations.
Primary Aim 1. To examine the efficacy of a tailored intervention delivered via the Internet designed to increase skin protection and decrease sun exposure behavior among young adults at moderate to high risk of developing skin cancer. Participants will be randomized to the tailored intervention, the Skin Cancer Foundation website, or an assessment only condition.
Aim 2. To evaluate whether sociodemographic variables (sex, race/ethnicity, skin type, family history of skin cancer), appearance consciousness, and past exposure and protective behaviors moderate intervention effects.
Aim 3. To evaluate whether Integrative Model constructs (UV-related knowledge, risk perception, beliefs, norms, self-efficacy, and intentions) mediate intervention effects.
The goals of future research would be to enhance the tailored intervention, for example, by adding additional contacts or Internet technologies or features, disseminate the intervention, assess the longevity of effects, and/or adapt the tailored intervention for use with other cancer risk behaviors or at risk groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tailored Intervention | Experimental | Behavioral: UV4meSubject has access to the tailored web intervention |
| Skin Cancer Foundation Website | Active comparator | Behavioral: Skin Cancer Foundation websiteSubject has access to the pre-existing Skin Cancer Foundation website |
| Assessment Only Condition | No intervention | –Subjects will only complete assessments |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18-25 years old
- Moderate to high risk of skin cancer (cut-off of >=27 on the Brief Skin Cancer Risk Assessment Tool)
Key exclusion criteria (1 listed)
- History of skin cancer
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 |
|---|---|---|
| UV4meAlso: Tailored Intervention for Skin Cancer Risk ReductionTailored website includes: personalized responses to quizzes, information on skin type and burn risk, UV damage photo of similar individual, avatar activity, age progression images, personal risk calculator, SPF (sun protection factor) calculator | Behavioural | Tailored Intervention |
| Skin Cancer Foundation websiteCurrent best practice website for skin cancer and prevention. Includes information, images, news, and opportunities for advocacy. | Behavioural | Skin Cancer Foundation Website |
Primary outcome
Sun protection
Time frame: Follow-up 1 (3 weeks after baseline)
Continuous measure examining frequency of sun protection behaviors (e.g., sunscreen use, clothing, shade, sunglasses), using items adapted from Glanz and colleagues (2008)
Sun protection
Time frame: Follow-up 2 (12 weeks after baseline)
Continuous measure examining frequency of sun protection behaviors (e.g., sunscreen use, clothing, shade, sunglasses), using items adapted from Glanz and colleagues (2008)
Outdoor UV Exposure
Time frame: Follow-up 1 (3 weeks after baseline)
How many hours participants spend in the sun during peak daylight hours during the week
Outdoor UV exposure
Time frame: Follow-up 2 (12 weeks after baseline)
How many hours participants spend in the sun during peak daylight hours during the week
2 secondary outcomes
Indoor Tanning
Time frame: Follow-up 1 (3 weeks after baseline)
Indoor Tanning
Time frame: Follow-up 2 (12 weeks after baseline)
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 3 Jul 2018.
- Derived from this study: PubMed 27819460Heckman CJ, Handorf EA, Darlow SD, Ritterband LM, Manne SL. An online skin cancer risk-reduction intervention for young adults: Mechanisms of effects. Health Psychol. 2017 Mar;36(3):215-225. doi: 10.1037/hea0000420. Epub 2016 Nov 7.
- Derived from this study: PubMed 26810358Heckman CJ, Darlow SD, Ritterband LM, Handorf EA, Manne SL. Efficacy of an Intervention to Alter Skin Cancer Risk Behaviors in Young Adults. Am J Prev Med. 2016 Jul;51(1):1-11. doi: 10.1016/j.amepre.2015.11.008. Epub 2016 Jan 22.
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.
Carolyn Heckman, Ph.D principal investigator
Fox Chase Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UV4me and Skin Cancer Foundation website in people with Skin Neoplasms, run by Fox Chase 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 2 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 3 Jul 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?
Sun protection (time frame: Follow-up 1 (3 weeks after baseline)). The study lists 4 primary outcomes in all. 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 NCT02147080, 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 3 Jul 2018.