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

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ClinicalTrials.gov Identifier: NCT03725449
Recruitment Status : Recruiting
First Posted : October 31, 2018
Last Update Posted : July 9, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Elliot J. Coups, PhD, Rutgers, The State University of New Jersey

Brief 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.

Condition or disease Intervention/treatment Phase
Dysplastic Nevus Health Status Unknown Melanoma No Evidence of Disease Other: Best Practice Behavioral: mySmartCheck Other: Survey Administration Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Online Intervention for Skin Self-Checks Among Individuals at Increased Risk for Melanoma
Actual Study Start Date : November 3, 2018
Estimated Primary Completion Date : December 3, 2020
Estimated Study Completion Date : December 3, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: Phase I (user testing)
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.
Behavioral: mySmartCheck
Receive access to mySmartcheck program

Experimental: Phase II Group I (mySmartCheck)
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.
Other: Best Practice
Receive standard of care
Other Names:
  • standard of care
  • standard therapy

Other: Survey Administration
Ancillary studies

Experimental: Phase II Group II (standard of care)
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.
Other: Best Practice
Receive standard of care
Other Names:
  • standard of care
  • standard therapy

Other: Survey Administration
Ancillary studies




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03725449


Locations
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United States, New Jersey
Rutgers Cancer Institute of New Jersey Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Elliot J. Coups    732-235-8076    coupsej@cinj.rutgers.edu   
Principal Investigator: Elliot J. Coups         
Sponsors and Collaborators
Rutgers, The State University of New Jersey
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Elliot Coups Rutgers Cancer Institute of New Jersey

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Responsible Party: Elliot J. Coups, PhD, Associate Professor, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT03725449     History of Changes
Other Study ID Numbers: 131707
NCI-2018-02006 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Pro20170000597
131707 ( Other Identifier: Rutgers Cancer Institute of New Jersey )
P30CA072720 ( U.S. NIH Grant/Contract )
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Melanoma
Dysplastic Nevus Syndrome
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Nevus
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn