Internet-based Intervention for Skin Self-Examination in Participants With Increased Risk for Melanoma
- Conditions
- Dysplastic NevusMelanomaHealth Status UnknownNo Evidence of Disease
- Interventions
- Behavioral: mySmartCheckOther: Best PracticeOther: Survey Administration
- Registration Number
- NCT03725449
- Lead Sponsor
- Rutgers, The State University of New Jersey
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 116
- 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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Phase I (user testing) mySmartCheck Participants complete 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 Group I (mySmartCheck) Best Practice Participants are asked to complete a baseline survey. After completing the baseline survey, participants receive access to mySmartCheck program, and continue to receive standard of care. Participants are asked to complete another survey 13 weeks post-baseline. Phase II Group I (mySmartCheck) Survey Administration Participants are asked to complete a baseline survey. After completing the baseline survey, participants receive access to mySmartCheck program, and continue to receive standard of care. Participants are asked to complete another survey 13 weeks post-baseline. Phase II Group II (standard of care) Survey Administration Participants are asked to complete a baseline survey. After completing the baseline survey, participants receive standard of care. Participants are asked to complete another survey 13 weeks post-baseline. Phase II Group II (standard of care) Best Practice Participants are asked to complete a baseline survey. After completing the baseline survey, participants receive standard of care. Participants are asked to complete another survey 13 weeks post-baseline.
- Primary Outcome Measures
Name Time Method Performance of thorough skin-self examination (SSE) 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 Outcome Measures
Name Time Method Performance of thorough SSE in the past 1 month 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 1 month
Number of SSEs performed (regardless of thoroughness) Up to 13 weeks The total number of self-reported SSEs performed (regardless of their thoroughness)
Number of body areas examined during SSE Up to 13 weeks The number of body areas (out of 15 total) examined during each SSE will be recorded.
Benefits to SSE Up to 13 weeks The impact of mySmartCheck on patients' benefits to conducting SSE will be examined using 7 items.
Barriers to SSE Up to 13 weeks The impact of mySmartCheck on patients' barriers to conducting SSE will be examined using 10 items.
SSE self-efficacy Up to 13 weeks The impact of MySmartCheck on patient's SSE self-efficacy will be examined using 9 items.
Level of worry about melanoma Up to 13 weeks The impact of mySmartCheck on patients' level of worry about melanoma will be examined using 2 items.
Number of health care consultations Up to 13 weeks Survey questions will ask about the number of health care consultations related to skin cancer surveillance in the past 3 months. Questions will include consultation reasons and outcomes.
Barriers and facilitators to using mySmart check Up to 13 weeks Three multi-item scales will be used to measure barriers and facilitators to using the mySmartCheck program. The first scale is 15 items (5-point response scale from "not at all" to "a lot") adapted from The Internet Impact and Effectiveness Questionnaire. This scale measures patients' perceptions of an Internet intervention in terms of the program's effectiveness in resolving their targeted health condition. The second scale includes 18 items (3-point response scale from "not a problem" to "a major problem") adapted from the Internet Intervention Adherence Questionnaire. This scale is used to identify obstacles and barriers that interfere with using Internet intervention programs. The final scale includes 13 items (4-point response scale from "not at all" to "very") adapted from the Internet Evaluation and Utility Questionnaire. This scale measures patients' experiences and perceptions of an Internet intervention.
Trial Locations
- Locations (1)
Rutgers Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States