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

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03725449
• Other study ID #: Pro20170000597
• Secondary ID: NCI-2018-02006Pr
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

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

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