SMART Project in Preventing Skin Cancer (SMART)

Self-Monitoring and Readiness Texting Project (SMART)

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.

Study Overview

• Status: Completed
• Conditions: Skin Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Behavioral: Compliance Monitoring; Other: Health Telemonitoring

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 Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 25 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (self-monitoring); ARM I (SELF-MONITORING): Patients complete tanning and sun protection usage entries daily for 14 days.	Other: Questionnaire Administration; Ancillary studies; Behavioral: Compliance Monitoring; Record behavior
Experimental: Arm II (text messages); ARM II (TEXT MESSAGES): Patients receive individualized text messages based on baseline assessment of tanning motives (appearance, enjoyment, social) daily for 14 days.	Other: Questionnaire Administration; Ancillary studies; Other: Health Telemonitoring; Receive health monitoring text messages
Experimental: Arm III (self-monitoring, text messages); ARM III (COMBINED GROUP): Patients complete tanning and sun protection usage entries and also receive individualized text messages daily for 14 days.	Other: Questionnaire Administration; Ancillary studies; Behavioral: Compliance Monitoring; Record behavior; Other: Health Telemonitoring; Receive health monitoring text messages
Sham Comparator: Arm IV (questionnaire administration); ARM IV (CONTROL GROUP): Patients complete study assessments.	Other: Questionnaire Administration; Ancillary studies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fox Chase Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Carolyn Heckman, Fox Chase Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2013
• Primary Completion (Actual): July 30, 2014
• Study Completion (Actual): December 31, 2014

Study Registration Dates

• First Submitted: June 2, 2017
• First Submitted That Met QC Criteria: June 2, 2017
• First Posted (Actual): June 6, 2017

Study Record Updates

• Last Update Posted (Actual): August 1, 2018
• Last Update Submitted That Met QC Criteria: July 31, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: IRB12846 (Other Identifier: Fox Chase Cancer Center); P30CA006927 (U.S. NIH Grant/Contract); NCI-2015-02089 (Registry Identifier: CTRP (Clinical Trial Reporting Program))