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

Rutgers, The State University of New Jersey116 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: Up to 13 weeks

Secondary Outcomes

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

Time frame: Up to 13 weeks

Number of SSEs performed (regardless of thoroughness)

The total number of self-reported SSEs performed (regardless of their thoroughness)

Time frame: Up to 13 weeks

Number of body areas examined during SSE

The number of body areas (out of 15 total) examined during each SSE will be recorded.

Time frame: Up to 13 weeks

Benefits to SSE

The impact of mySmartCheck on patients' benefits to conducting SSE will be examined using 7 items.

Time frame: Up to 13 weeks

Barriers to SSE

The impact of mySmartCheck on patients' barriers to conducting SSE will be examined using 10 items.

Time frame: Up to 13 weeks

SSE self-efficacy

The impact of MySmartCheck on patient's SSE self-efficacy will be examined using 9 items.

Time frame: Up to 13 weeks

Level of worry about melanoma

The impact of mySmartCheck on patients' level of worry about melanoma will be examined using 2 items.

Time frame: Up to 13 weeks

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.

Time frame: Up to 13 weeks

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.

Time frame: Up to 13 weeks

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes