Clinical trial NCT03725449: Internet-based Intervention for Skin Self-Examination in Participants With Increased Risk for Melanoma
Official title: An Online Intervention for Skin Self-Checks Among Individuals at Increased Risk for Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysplastic Nevus
Health Status Unknown
Melanoma
No Evidence of Disease
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-10-31
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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.

Primary outcomes:
measure: Performance of thorough skin-self examination (SSE)
timeFrame: Up to 13 weeks
Secondary outcomes:
measure: Performance of thorough SSE in the past 1 month
timeFrame: Up to 13 weeks
measure: Number of SSEs performed (regardless of thoroughness)
timeFrame: Up to 13 weeks
measure: Number of body areas examined during SSE
timeFrame: Up to 13 weeks
measure: Benefits to SSE
timeFrame: Up to 13 weeks
measure: Barriers to SSE
timeFrame: Up to 13 weeks
measure: SSE self-efficacy
timeFrame: Up to 13 weeks
measure: Level of worry about melanoma
timeFrame: Up to 13 weeks
measure: Number of health care consultations
timeFrame: Up to 13 weeks
measure: Barriers and facilitators to using mySmart check
timeFrame: Up to 13 weeks
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Sharon Manne, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.