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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03725449
Other study ID # Pro20170000597
Secondary ID NCI-2018-02006Pr
Status Completed
Phase N/A
First received
Last updated
Start date November 3, 2018
Est. completion date August 29, 2020

Study information

Verified date November 2022
Source Rutgers, The State University of New Jersey
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 116
Est. completion date August 29, 2020
Est. primary completion date August 29, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 89 Years
Eligibility 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.

Study Design


Intervention

Other:
Best Practice
Receive standard of care
Behavioral:
mySmartCheck
Receive access to mySmartcheck program
Other:
Survey Administration
Ancillary studies

Locations

Country Name City State
United States Rutgers Cancer Institute of New Jersey New Brunswick New Jersey

Sponsors (2)

Lead Sponsor Collaborator
Rutgers, The State University of New Jersey National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Performance of thorough skin-self examination (SSE) 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 Up to 13 weeks
Secondary Performance of thorough SSE in the past 1 month 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 Up to 13 weeks
Secondary Number of SSEs performed (regardless of thoroughness) The total number of self-reported SSEs performed (regardless of their thoroughness) Up to 13 weeks
Secondary Number of body areas examined during SSE The number of body areas (out of 15 total) examined during each SSE will be recorded. Up to 13 weeks
Secondary Benefits to SSE The impact of mySmartCheck on patients' benefits to conducting SSE will be examined using 7 items. Up to 13 weeks
Secondary Barriers to SSE The impact of mySmartCheck on patients' barriers to conducting SSE will be examined using 10 items. Up to 13 weeks
Secondary SSE self-efficacy The impact of MySmartCheck on patient's SSE self-efficacy will be examined using 9 items. Up to 13 weeks
Secondary Level of worry about melanoma The impact of mySmartCheck on patients' level of worry about melanoma will be examined using 2 items. Up to 13 weeks
Secondary Number of health care consultations 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. Up to 13 weeks
Secondary Barriers and facilitators to using mySmart check 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. Up to 13 weeks
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