- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Förenta staterna, 19111
- Fox Chase Cancer Center
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Tailored Intervention
Subject has access to the tailored web intervention
|
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
Andra namn:
|
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Aktiv komparator: Skin Cancer Foundation Website
Subject has access to the pre-existing Skin Cancer Foundation website
|
Current best practice website for skin cancer and prevention.
Includes information, images, news, and opportunities for advocacy.
|
|
Inget ingripande: Assessment Only Condition
Subjects will only complete assessments
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Sun protection
Tidsram: 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)
|
Follow-up 1 (3 weeks after baseline)
|
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Sun protection
Tidsram: 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
Tidsram: 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
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Indoor Tanning
Tidsram: Follow-up 1 (3 weeks after baseline)
|
Number of indoor tanning sessions in past month
|
Follow-up 1 (3 weeks after baseline)
|
|
Indoor Tanning
Tidsram: Follow-up 2 (12 weeks after baseline)
|
Number of indoor tanning sessions in past month
|
Follow-up 2 (12 weeks after baseline)
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Spray-on tan
Tidsram: Follow-up 1 (3 weeks after baseline)
|
Number of spray-on tanning sessions in past month
|
Follow-up 1 (3 weeks after baseline)
|
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Spray-on tan
Tidsram: 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
Tidsram: 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)
|
|
Sunless tanning creams
Tidsram: 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)
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Carolyn Heckman, Ph.D, Fox Chase Cancer Center
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1R01CA154928-01 (U.S.S. NIH-anslag/kontrakt)
- 1R01CA154928 (U.S.S. NIH-anslag/kontrakt)
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