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

An Online Intervention for Skin Self-Checks Among Individuals at 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.

Study Overview

• Status: Completed
• Conditions: Melanoma; Health Status Unknown; Dysplastic Nevus; No Evidence of Disease
• Intervention / Treatment: Other: Survey Administration; Other: Best Practice; Behavioral: mySmartCheck

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.

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08903
      • Rutgers Cancer Institute of New Jersey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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: Survey Administration; Ancillary studies; Other: Best Practice; Receive standard of care; Other Names: standard of care; standard therapy
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: Survey Administration; Ancillary studies; Other: Best Practice; Receive standard of care; Other Names: standard of care; standard therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number of SSEs performed (regardless of thoroughness)	The total number of self-reported SSEs performed (regardless of their thoroughness)	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.	Up to 13 weeks
Benefits to SSE	The impact of mySmartCheck on patients' benefits to conducting SSE will be examined using 7 items.	Up to 13 weeks
Barriers to SSE	The impact of mySmartCheck on patients' barriers to conducting SSE will be examined using 10 items.	Up to 13 weeks
SSE self-efficacy	The impact of MySmartCheck on patient's SSE self-efficacy will be examined using 9 items.	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.	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.	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.	Up to 13 weeks

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Sharon Manne, PhD, Rutgers Cancer Institute of New Jersey

Publications and helpful links

General Publications

• Manne SL, Marchetti MA, Kashy DA, Heckman CJ, Ritterband LM, Thorndike FP, Viola A, Lozada C, Coups EJ. mySmartCheck, a Digital Intervention to Promote Skin Self-examination Among Individuals Diagnosed With or at Risk for Melanoma: A Randomized Clinical Trial. Ann Behav Med. 2022 Aug 2;56(8):791-803. doi: 10.1093/abm/kaab090.

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2018
• Primary Completion (Actual): August 29, 2020
• Study Completion (Actual): August 29, 2020

Study Registration Dates

• First Submitted: October 1, 2018
• First Submitted That Met QC Criteria: October 26, 2018
• First Posted (Actual): October 31, 2018

Study Record Updates

• Last Update Posted (Actual): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 11, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Genetic Diseases, Inborn; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neoplastic Syndromes, Hereditary; Neuroendocrine Tumors; Nevi and Melanomas; Nevus; Melanoma; Dysplastic Nevus Syndrome
• Other Study ID Numbers: Pro20170000597; P30CA072720 (U.S. NIH Grant/Contract); NCI-2018-02006 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); 131707 (Other Identifier: Rutgers Cancer Institute of New Jersey)

Drug and device information, study documents

• 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