NCT03725449

Internet-based Intervention for Skin Self-Examination in Participants With Increased Risk for Melanoma

An Online Intervention for Skin Self-Checks Among Individuals at Increased Risk for Melanoma

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Accepted

Summary

This trial studies an internet-based intervention for skin self-examination (SSE) in participants at increased risk for melanoma. Early detection of suspicious growths on the skin can be done by performing regular SSE checks. Using an internet-based intervention, such as mySmartCheck, may help to promote regular, thorough checks on the skin in individuals at increased risk for melanoma.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the impact of mySmartCheck versus usual care on skin-self-examination (SSE) behaviors among individuals at increased risk for developing melanoma. SECONDARY OBJECTIVES: I. To evaluate the impact of mySmartCheck versus usual care on patients barriers and benefits to conducting SSE, SSE self-efficacy (confidence), level of worry about developing melanoma, and number of health care consultations (visits, telephone calls, and emails). II. To evaluate whether mySmartCheck effects are moderated by the patient's Total Body Photography (TBP) status. III. To identify barriers and facilitators to using mySmartCheck. OUTLINE: PHASE I: Participants complete a telephone based usability testing of the online program. Participants complete between 1-5 user testing sessions of the mySmartCheck program (about 45-60 minutes per session) to provide feedback on acceptability, satisfaction, comprehension, and usability. PHASE II: Participants are randomized to 1 of 2 groups. Both the intervention and control group complete a baseline survey as well as a 13 weeks post-baseline survey. GROUP I: After completing the baseline survey, participants receive access to the mySmartCheck program, and continue to receive standard of care. Participants are asked to complete another survey 13 weeks post-baseline. GROUP II: After completing the baseline survey, participants receive standard of care. Participants are asked to complete another survey 13 weeks post-baseline. Study duration is 13 weeks for all participants.

Conditions

• Dysplastic Nevus
• Health Status Unknown
• Melanoma
• No Evidence of Disease

Interventions

Type	Name	Description
OTHER	Best Practice	Receive standard of care
BEHAVIORAL	mySmartCheck	Receive access to mySmartcheck program
OTHER	Survey Administration	Ancillary studies

Timeline

• Start date: 2018-11-03
• Primary completion: 2020-08-29
• Completion: 2020-08-29
• First posted: 2018-10-31
• Last updated: 2022-11-14

Locations

1 site across 1 country: United States