SMART Project in Preventing Skin Cancer

Not Applicable

Completed

• Conditions: Skin Carcinoma
• Interventions: Other: Questionnaire Administration; Behavioral: Compliance Monitoring; Other: Health Telemonitoring

• Registration Number: NCT03177057
• Lead Sponsor: Fox Chase Cancer Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2013-04-23
• Primary Completion: 2014-07-30
• Study Completion: 2014-12-31
• Study First Submitted: 2017-06-02
• Study First Submitted QC: 2017-06-02
• Study First Posted: 2017-06-06
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-31
• Last Update Posted: 2018-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 114

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm IV (questionnaire administration)	Questionnaire Administration	ARM IV (CONTROL GROUP): Patients complete study assessments.
Arm III (self-monitoring, text messages)	Compliance Monitoring	ARM III (COMBINED GROUP): Patients complete tanning and sun protection usage entries and also receive individualized text messages daily for 14 days.
Arm III (self-monitoring, text messages)	Health Telemonitoring	ARM III (COMBINED GROUP): Patients complete tanning and sun protection usage entries and also receive individualized text messages daily for 14 days.
Arm II (text messages)	Questionnaire Administration	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 (self-monitoring, text messages)	Questionnaire Administration	ARM III (COMBINED GROUP): Patients complete tanning and sun protection usage entries and also receive individualized text messages daily for 14 days.
Arm I (self-monitoring)	Compliance Monitoring	ARM I (SELF-MONITORING): Patients complete tanning and sun protection usage entries daily for 14 days.
Arm I (self-monitoring)	Questionnaire Administration	ARM I (SELF-MONITORING): Patients complete tanning and sun protection usage entries daily for 14 days.
Arm II (text messages)	Health Telemonitoring	ARM II (TEXT MESSAGES): Patients receive individualized text messages based on baseline assessment of tanning motives (appearance, enjoyment, social) daily for 14 days.

Primary Outcome Measures

Name	Time	Method
Change in ultraviolet radiation (UV) exposure and sun protection behaviors based on behavior tracking and individually tailored daily text messages	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 Outcome Measures

Name	Time	Method
Mediators and moderators of the intervention on behavior	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

Trial Locations

Locations (1)

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States