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

Rutgers The State University of New Jersey

Status: Completed

Conditions: Melanoma; Health Status Unknown; Dysplastic Nevus; No Evidence of Disease

Treatments: Other: Best Practice; Other: Survey Administration; Behavioral: mySmartCheck

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03725449

131707 (Other Identifier)

P30CA072720 (U.S. NIH Grant/Contract)

NCI-2018-02006 (Registry Identifier)

Pro20170000597

Details and patient eligibility

About

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.

Full 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.

Enrollment: 116 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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116 participants in 3 patient groups

Phase I (user testing)

Experimental group

Description:

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.

Treatment:

Behavioral: mySmartCheck

Phase II Group I (mySmartCheck)

Experimental group

Description:

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.

Treatment:

Other: Survey Administration

Other: Best Practice

Phase II Group II (standard of care)

Experimental group

Description:

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.

Treatment:

Other: Survey Administration

Other: Best Practice