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

NCT03725449 | Completed

• 4 other identifiers: Pro20170000597NCI-2018-02006131707P30CA072720
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Performance of thorough SSE in the past 1 month

  Up to 13 weeks

• Number of SSEs performed (regardless of thoroughness)

  Up to 13 weeks

• Number of body areas examined during SSE

  Up to 13 weeks

• Benefits to SSE

  Up to 13 weeks

• Barriers to SSE

  Up to 13 weeks

Study Arms (3)

Phase I (user testing)

EXPERIMENTAL

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

Phase II Group I (mySmartCheck)

EXPERIMENTAL

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; Other: Survey Administration

Phase II Group II (standard of care)

EXPERIMENTAL

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; Other: Survey Administration

Interventions

Best Practice OTHER

Receive standard of care

Also known as: standard of care, standard therapy

Phase II Group I (mySmartCheck); Phase II Group II (standard of care)

mySmartCheck BEHAVIORAL

Receive access to mySmartcheck program

Phase I (user testing)

Survey Administration OTHER

Ancillary studies

Phase II Group I (mySmartCheck); Phase II Group II (standard of care)

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

Related Publications (1)

• 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.

  PMID: 34637495 DERIVED

MeSH Terms

Conditions

Dysplastic Nevus Syndrome; Melanoma

Interventions

Practice Guidelines as Topic; Standard of Care

Condition Hierarchy (Ancestors)

Nevus; Nevi and Melanomas; Neoplasms by Histologic Type; Neoplasms; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Study Officials

• Sharon Manne, PhD

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 1, 2018
• First Posted: October 31, 2018
• Study Start: November 3, 2018
• Primary Completion: August 29, 2020
• Study Completion: August 29, 2020
• Last Updated: November 14, 2022

Record last verified: 2022-11

Locations

US (1)