An Online Intervention for Skin Self-Checks Among Individuals at Increased Risk for Melanoma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dysplastic Nevus
- Sponsor
- Rutgers, The State University of New Jersey
- Enrollment
- 116
- Locations
- 1
- Primary Endpoint
- Performance of thorough skin-self examination (SSE)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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.
Investigators
Sharon Manne, PhD
Associate Professor
Rutgers, The State University of New Jersey
Eligibility Criteria
Inclusion Criteria
- •At increased risk for melanoma due to a personal history of treated melanoma without current evidence of disease, a family history of melanoma in a first-degree relative, and/or having a high-risk mole phenotype (i.e., \>= 50 normal moles or \>= 1 abnormal mole \[dysplastic nevus\]).
- •Access to a computer connected to the Internet.
- •Not adherent to SSE recommendations (i.e., did not conduct a thorough SSE during each of the previous 3 months).
- •Able to speak and read English.
- •Able to provide informed consent.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Performance of thorough skin-self examination (SSE)
Time Frame: Up to 13 weeks
Thorough SSE is defined as thoroughly examining each area of the body during the most recent SSE skin self-check in the past 2 months
Secondary Outcomes
- Performance of thorough SSE in the past 1 month(Up to 13 weeks)
- Number of SSEs performed (regardless of thoroughness)(Up to 13 weeks)
- Number of body areas examined during SSE(Up to 13 weeks)
- Benefits to SSE(Up to 13 weeks)
- Barriers to SSE(Up to 13 weeks)
- SSE self-efficacy(Up to 13 weeks)
- Level of worry about melanoma(Up to 13 weeks)
- Number of health care consultations(Up to 13 weeks)
- Barriers and facilitators to using mySmart check(Up to 13 weeks)