SMART Project in Preventing Skin Cancer

Skin Carcinoma Clinical Trial

— SMART  

Official title:

Self-Monitoring and Readiness Texting Project (SMART)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03177057
• Other study ID #: IRB12846
• Secondary ID: NCI-2015-02089IR
• Status: Completed
• Phase: N/A
• Start date: April 23, 2013
• Est. completion date: December 31, 2014

Study information

• Verified date: July 2018
• Source: Fox Chase Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: December 31, 2014
• Est. primary completion date: July 30, 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 29 Years

Eligibility

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

Related Conditions & MeSH terms

• Skin Carcinoma

Intervention

Behavioral:
• Compliance Monitoring
Record behavior

Other:
• Health Telemonitoring
Receive health monitoring text messages
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Fox Chase Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in ultraviolet radiation (UV) exposure and sun protection behaviors based on behavior tracking and individually tailored daily text messages	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.	Baseline to up to 2 weeks
Secondary	Mediators and moderators of the intervention on behavior	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	At 2 weeks