SMART Project in Preventing Skin Cancer

NCT ID: NCT03177057

Last Updated: 2018-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-23

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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Skin Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Arm I (self-monitoring)

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

Group Type EXPERIMENTAL

Compliance Monitoring

Intervention Type BEHAVIORAL

Record behavior

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

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.

Group Type EXPERIMENTAL

Health Telemonitoring

Intervention Type OTHER

Receive health monitoring text messages

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

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.

Group Type EXPERIMENTAL

Compliance Monitoring

Intervention Type BEHAVIORAL

Record behavior

Health Telemonitoring

Intervention Type OTHER

Receive health monitoring text messages

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Arm IV (questionnaire administration)

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

Group Type SHAM_COMPARATOR

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Compliance Monitoring

Record behavior

Intervention Type BEHAVIORAL

Health Telemonitoring

Receive health monitoring text messages

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

29 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Fox Chase Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Carolyn Heckman

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carolyn Heckman

Role: PRINCIPAL_INVESTIGATOR

Fox Chase Cancer Center

Locations

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Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2015-02089

Identifier Type: REGISTRY

Identifier Source: secondary_id

IRB12846

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA006927

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB12846

Identifier Type: -

Identifier Source: org_study_id

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