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Completed

NCT Number: NCT03725449

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

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.

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Key information

Conditions

Dysplastic Nevus Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dysplastic Nevus Syndrome Genetic Diseases, Inborn Health Status Unknown Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neoplastic Syndromes, Hereditary Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Nevus No Evidence of Disease Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Best Practice

Other

Receive standard of care

Other names: standard of care, standard therapy

mySmartCheck

Behavioral

Receive access to mySmartcheck program

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. Performance of thorough skin-self examination (SSE)

    Time frame: 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 outcomes

  1. Performance of thorough SSE in the past 1 month

    Time frame: 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

  2. Number of SSEs performed (regardless of thoroughness)

    Time frame: Up to 13 weeks

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

  3. Number of body areas examined during SSE

    Time frame: Up to 13 weeks

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

  4. Benefits to SSE

    Time frame: Up to 13 weeks

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

  5. Barriers to SSE

    Time frame: Up to 13 weeks

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

  6. SSE self-efficacy

    Time frame: Up to 13 weeks

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

  7. Level of worry about melanoma

    Time frame: Up to 13 weeks

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

  8. Number of health care consultations

    Time frame: 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.

  9. Barriers and facilitators to using mySmart check

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 31, 2018
Registry last updated
Nov 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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