NCT02147080

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,234

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

May 22, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 26, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

July 3, 2018

Status Verified

June 1, 2018

Enrollment Period

3.6 years

First QC Date

May 22, 2014

Last Update Submit

June 29, 2018

Conditions

Skin Neoplasms

Keywords

prevention or control

Outcome Measures

Primary Outcomes (4)

  • 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)

  • 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)

  • 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)

  • 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 Outcomes (2)

  • Indoor Tanning

    Follow-up 1 (3 weeks after baseline)

  • Indoor Tanning

    Follow-up 2 (12 weeks after baseline)

Other Outcomes (4)

  • Spray-on tan

    Follow-up 1 (3 weeks after baseline)

  • Spray-on tan

    Follow-up 2 (12 weeks after baseline)

  • Sunless tanning creams

    Follow-up 1 (3 weeks after baseline)

  • +1 more other outcomes

Study Arms (3)

Tailored Intervention

EXPERIMENTAL

Subject has access to the tailored web intervention

Behavioral: UV4me

Skin Cancer Foundation Website

ACTIVE COMPARATOR

Subject has access to the pre-existing Skin Cancer Foundation website

Behavioral: Skin Cancer Foundation website

Assessment Only Condition

NO INTERVENTION

Subjects will only complete assessments

Interventions

UV4meBEHAVIORAL

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

Also known as: Tailored Intervention for Skin Cancer Risk Reduction
Tailored Intervention
Skin Cancer Foundation websiteBEHAVIORAL

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

Skin Cancer Foundation Website

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-25 years old
  • Moderate to high risk of skin cancer (cut-off of \>=27 on the Brief Skin Cancer Risk Assessment Tool)

You may not qualify if:

  • History of skin cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Related Publications (2)

  • 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.

    PMID: 27819460DERIVED

  • 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.

    PMID: 26810358DERIVED

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Carolyn Heckman, Ph.D

    Fox Chase Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 22, 2014

First Posted

May 26, 2014

Study Start

March 1, 2011

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

July 3, 2018

Record last verified: 2018-06

Locations

US(1)