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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02147080
Other study ID # 1R01CA154928-01
Secondary ID 1R01CA154928
Status Completed
Phase N/A
First received
Last updated
Start date March 2011
Est. completion date October 2014

Study information

Verified date June 2018
Source Fox Chase Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 1234
Est. completion date October 2014
Est. primary completion date October 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria:

- Age 18-25 years old

- Moderate to high risk of skin cancer (cut-off of >=27 on the Brief Skin Cancer Risk Assessment Tool)

Exclusion Criteria:

- History of skin cancer

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
UV4me
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 website
Current best practice website for skin cancer and prevention. Includes information, images, news, and opportunities for advocacy.

Locations

Country Name City State
United States Fox Chase Cancer Center Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Fox Chase Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Spray-on tan Number of spray-on tanning sessions in past month Follow-up 1 (3 weeks after baseline)
Other Spray-on tan Number of spray-on tanning sessions in past month Follow-up 2 (12 weeks after baseline)
Other Sunless tanning creams Number of times sunless tanning cream has been used in the past month Follow-up 1 (3 weeks after baseline)
Other Sunless tanning creams Number of times sunless tanning cream has been used in the past month Follow-up 2 (12 weeks after baseline)
Primary 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) Follow-up 1 (3 weeks after baseline)
Primary 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) Follow-up 2 (12 weeks after baseline)
Primary Outdoor UV Exposure How many hours participants spend in the sun during peak daylight hours during the week Follow-up 1 (3 weeks after baseline)
Primary Outdoor UV exposure How many hours participants spend in the sun during peak daylight hours during the week Follow-up 2 (12 weeks after baseline)
Secondary Indoor Tanning Number of indoor tanning sessions in past month Follow-up 1 (3 weeks after baseline)
Secondary Indoor Tanning Number of indoor tanning sessions in past month Follow-up 2 (12 weeks after baseline)
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