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Completed

NCT Number: NCT03177057

SMART Project in Preventing Skin Cancer

This pilot clinical trial studies how well Self Monitoring And Readiness Texting (SMART) project works in sun exposure and protection behaviors. Measuring how behavior tracking and individually tailored messages affect risk behaviors in patients with skin cancer may help doctors plan the best prevention plan and decrease national melanoma incidence and mortality.

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Key information

Conditions

Skin Carcinoma

Age range

18 year–29 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

About this study

PRIMARY OBJECTIVES:

I. To test the effects of a behavior tracking and individually-tailored daily text message intervention on sun protection and exposure behaviors and to see if these techniques will be most effective in conjunction or separately.

SECONDARY OBJECTIVES:

I. To examine mediators in the effects of the intervention on safe sun behaviors, based on Fishbein?s Integrative Model.

OUTLINE: Patients are randomized to 1 of 4 study arms.

ARM I (SELF-MONITORING): Patients complete tanning and sun protection usage entries daily for 14 days.

ARM II (TEXT MESSAGES): Patients receive individualized text messages based on baseline assessment of tanning motives (appearance, enjoyment, social) daily for 14 days.

ARM III (COMBINED GROUP): Patients complete tanning and sun protection usage entries and also receive individualized text messages daily for 14 days.

ARM IV (CONTROL GROUP): Patients complete study assessments.

After completion of study, patients are followed up at 2 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women from the Philadelphia metropolitan area who own a mobile phone and who meet criteria for at least moderate risk of skin cancer based on a brief risk assessment tool

Treatment and study plan

compliance monitoring

Behavioral

Record behavior

Health Telemonitoring

Other

Receive health monitoring text messages

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Change in ultraviolet radiation (UV) exposure and sun protection behaviors based on behavior tracking and individually tailored daily text messages

    Time frame: Baseline to up to 2 weeks

    Multiple variable regression models will be performed to examine the effect of the intervention on the outcomes. All post-baseline outcomes will be used as dependent variables. The baseline scores, intervention group, and time of the assessment will be included. To account for the within subject correlation of the responses, we will fit the model using Generalized Estimating Equations assuming an autoregressive working correlation matrix for each subject. Any p-value from the pairwise comparison that is less than 0.05 will be considered worthy of further study.

Secondary outcomes

  1. Mediators and moderators of the intervention on behavior

    Time frame: At 2 weeks

    Mediation will be assessed by examining indirect effects, with bootstrapped confidence intervals to be calculated around the mediated effects. For participants who use the self-monitoring app, hierarchical linear modeling will be used to examine associations between tanning and sun protection as they occur daily, and motives for doing so. Using lagged multi-level models, the within-person model allows for assessment of individual change in behavior over the two-week time period, as well as the effect of each day?s behavior on behavior occurring on subsequent days. The between-person model allo

Sponsors and collaborators

Lead sponsor

Fox Chase Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Self-Monitoring and Readiness Texting Project (SMART)

Acronym: SMART

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 6, 2017
Registry last updated
Aug 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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