SMART Project in Preventing Skin Cancer
SMART
Self-Monitoring and Readiness Texting Project (SMART)
3 other identifiers
interventional
114
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 23, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2014
CompletedFirst Submitted
Initial submission to the registry
June 2, 2017
CompletedFirst Posted
Study publicly available on registry
June 6, 2017
CompletedAugust 1, 2018
July 1, 2018
1.3 years
June 2, 2017
July 31, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Mediators and moderators of the intervention on behavior
At 2 weeks
Study Arms (4)
Arm I (self-monitoring)
EXPERIMENTALARM I (SELF-MONITORING): Patients complete tanning and sun protection usage entries daily for 14 days.
Arm II (text messages)
EXPERIMENTALARM 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)
EXPERIMENTALARM III (COMBINED GROUP): Patients complete tanning and sun protection usage entries and also receive individualized text messages daily for 14 days.
Arm IV (questionnaire administration)
SHAM COMPARATORARM IV (CONTROL GROUP): Patients complete study assessments.
Interventions
Record behavior
Receive health monitoring text messages
Ancillary studies
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fox Chase Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Carolyn Heckman
Fox Chase Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 2, 2017
First Posted
June 6, 2017
Study Start
April 23, 2013
Primary Completion
July 30, 2014
Study Completion
December 31, 2014
Last Updated
August 1, 2018
Record last verified: 2018-07