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

Primary Purpose

Dysplastic Nevus, Health Status Unknown, Melanoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Best Practice
mySmartCheck
Survey Administration
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dysplastic Nevus

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Rutgers Cancer Institute of New Jersey

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Phase I (user testing)

Phase II Group I (mySmartCheck)

Phase II Group II (standard of care)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Number of SSEs performed (regardless of thoroughness)
The total number of self-reported SSEs performed (regardless of their thoroughness)
Number of body areas examined during SSE
The number of body areas (out of 15 total) examined during each SSE will be recorded.
Benefits to SSE
The impact of mySmartCheck on patients' benefits to conducting SSE will be examined using 7 items.
Barriers to SSE
The impact of mySmartCheck on patients' barriers to conducting SSE will be examined using 10 items.
SSE self-efficacy
The impact of MySmartCheck on patient's SSE self-efficacy will be examined using 9 items.
Level of worry about melanoma
The impact of mySmartCheck on patients' level of worry about melanoma will be examined using 2 items.
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.
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.

Full Information

First Posted
October 1, 2018
Last Updated
November 11, 2022
Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03725449
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
November 3, 2018 (Actual)
Primary Completion Date
August 29, 2020 (Actual)
Study Completion Date
August 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI)

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysplastic Nevus, Health Status Unknown, Melanoma, No Evidence of Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase I (user testing)
Arm Type
Experimental
Arm Description
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.
Arm Title
Phase II Group I (mySmartCheck)
Arm Type
Experimental
Arm Description
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.
Arm Title
Phase II Group II (standard of care)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Best Practice
Other Intervention Name(s)
standard of care, standard therapy
Intervention Description
Receive standard of care
Intervention Type
Behavioral
Intervention Name(s)
mySmartCheck
Intervention Description
Receive access to mySmartcheck program
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Performance of thorough skin-self examination (SSE)
Description
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
Time Frame
Up to 13 weeks
Secondary Outcome Measure Information:
Title
Performance of thorough SSE in the past 1 month
Description
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
Time Frame
Up to 13 weeks
Title
Number of SSEs performed (regardless of thoroughness)
Description
The total number of self-reported SSEs performed (regardless of their thoroughness)
Time Frame
Up to 13 weeks
Title
Number of body areas examined during SSE
Description
The number of body areas (out of 15 total) examined during each SSE will be recorded.
Time Frame
Up to 13 weeks
Title
Benefits to SSE
Description
The impact of mySmartCheck on patients' benefits to conducting SSE will be examined using 7 items.
Time Frame
Up to 13 weeks
Title
Barriers to SSE
Description
The impact of mySmartCheck on patients' barriers to conducting SSE will be examined using 10 items.
Time Frame
Up to 13 weeks
Title
SSE self-efficacy
Description
The impact of MySmartCheck on patient's SSE self-efficacy will be examined using 9 items.
Time Frame
Up to 13 weeks
Title
Level of worry about melanoma
Description
The impact of mySmartCheck on patients' level of worry about melanoma will be examined using 2 items.
Time Frame
Up to 13 weeks
Title
Number of health care consultations
Description
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.
Time Frame
Up to 13 weeks
Title
Barriers and facilitators to using mySmart check
Description
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.
Time Frame
Up to 13 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Manne, PhD
Organizational Affiliation
Rutgers Cancer Institute of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34637495
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.
Results Reference
derived

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

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