- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02147080
A Tailored Internet Intervention to Reduce Skin Cancer Risk Behaviors Among Young Adults (UV4me)
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19111
- Fox Chase Cancer Center
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Tailored Intervention
Subject has access to the tailored web intervention
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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
Andre navn:
|
|
Aktiv komparator: Skin Cancer Foundation Website
Subject has access to the pre-existing Skin Cancer Foundation website
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Current best practice website for skin cancer and prevention.
Includes information, images, news, and opportunities for advocacy.
|
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Ingen inngripen: Assessment Only Condition
Subjects will only complete assessments
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Sun protection
Tidsramme: 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)
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Follow-up 1 (3 weeks after baseline)
|
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Sun protection
Tidsramme: 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)
|
Follow-up 2 (12 weeks after baseline)
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Outdoor UV Exposure
Tidsramme: Follow-up 1 (3 weeks after baseline)
|
How many hours participants spend in the sun during peak daylight hours during the week
|
Follow-up 1 (3 weeks after baseline)
|
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Outdoor UV exposure
Tidsramme: Follow-up 2 (12 weeks after baseline)
|
How many hours participants spend in the sun during peak daylight hours during the week
|
Follow-up 2 (12 weeks after baseline)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Indoor Tanning
Tidsramme: Follow-up 1 (3 weeks after baseline)
|
Number of indoor tanning sessions in past month
|
Follow-up 1 (3 weeks after baseline)
|
|
Indoor Tanning
Tidsramme: Follow-up 2 (12 weeks after baseline)
|
Number of indoor tanning sessions in past month
|
Follow-up 2 (12 weeks after baseline)
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Spray-on tan
Tidsramme: Follow-up 1 (3 weeks after baseline)
|
Number of spray-on tanning sessions in past month
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Follow-up 1 (3 weeks after baseline)
|
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Spray-on tan
Tidsramme: Follow-up 2 (12 weeks after baseline)
|
Number of spray-on tanning sessions in past month
|
Follow-up 2 (12 weeks after baseline)
|
|
Sunless tanning creams
Tidsramme: Follow-up 1 (3 weeks after baseline)
|
Number of times sunless tanning cream has been used in the past month
|
Follow-up 1 (3 weeks after baseline)
|
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Sunless tanning creams
Tidsramme: Follow-up 2 (12 weeks after baseline)
|
Number of times sunless tanning cream has been used in the past month
|
Follow-up 2 (12 weeks after baseline)
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Carolyn Heckman, Ph.D, Fox Chase Cancer Center
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- Heckman 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1R01CA154928-01 (U.S. NIH-stipend/kontrakt)
- 1R01CA154928 (U.S. NIH-stipend/kontrakt)
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