Dysplastic NevusNCT03725449
Internet-based Intervention for Skin Self-Examination in Participants With Increased Risk for Melanoma
A study testing Best Practice, mySmartCheck and Survey Administration in people with Dysplastic Nevus and Health Status Unknown, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Dysplastic Nevus, Health Status Unknown, Melanoma
- What is being tested?
- Best Practice, mySmartCheck and Survey Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2018to 29 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Being tested
- Best Practice, mySmartCheck, Survey Administration
- Medical subject headings
- Dysplastic Nevus Syndrome, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive standard of care
mySmartCheckBehavioural
Receive access to mySmartcheck program
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Best Practice; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 13 weeks
Secondary outcomes (9)
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
Measured: Up to 13 weeks
Number of SSEs performed (regardless of thoroughness)
The total number of self-reported SSEs performed (regardless of their thoroughness)
Measured: 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.
Measured: Up to 13 weeks
Benefits to SSE
The impact of mySmartCheck on patients' benefits to conducting SSE will be examined using 7 items.
Measured: Up to 13 weeks
Barriers to SSE
The impact of mySmartCheck on patients' barriers to conducting SSE will be examined using 10 items.
Measured: Up to 13 weeks
SSE self-efficacy
The impact of MySmartCheck on patient's SSE self-efficacy will be examined using 9 items.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start3 Nov 2018
- Primary completion29 Aug 2020
- Study completion29 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dysplastic NevusStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Sharon Manne, PhD, Rutgers, The State University of New Jersey
- Investigators
- Sharon Manne, PhD, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03725449
- Sponsor's protocol ID
- Pro20170000597
- Other IDs
- NCI-2018-02006, Pro20170000597, 131707, P30CA072720
- Status last verified
- Nov 2022
- First submitted
- 1 Oct 2018
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 34637495
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Online Intervention for Skin Self-Checks Among Individuals at Increased Risk for Melanoma
- ClinicalTrials.gov ID
- NCT03725449
- Acronym / sponsor ID
- Pro20170000597
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 3 Nov 2018 (actual)
- Primary completion
- 29 Aug 2020 (actual)
- Study completion
- 29 Aug 2020 (actual)
- First posted
- 31 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase I (user testing) | Experimental | Behavioral: mySmartCheckParticipants 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. |
| Phase II Group I (mySmartCheck) | Experimental | Other: Best Practice, Other: Survey AdministrationParticipants 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. |
| Phase II Group II (standard of care) | Experimental | Other: Best Practice, Other: Survey AdministrationParticipants 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive standard of care | Other | Phase II Group I (mySmartCheck), Phase II Group II (standard of care) |
| mySmartCheckReceive access to mySmartcheck program | Behavioural | Phase I (user testing) |
| Survey AdministrationAncillary studies | Other | Phase II Group I (mySmartCheck), Phase II Group II (standard of care) |
Primary outcome
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
9 secondary outcomes
Performance of thorough SSE in the past 1 month
Time frame: Up to 13 weeks
Number of SSEs performed (regardless of thoroughness)
Time frame: Up to 13 weeks
Number of body areas examined during SSE
Time frame: Up to 13 weeks
Benefits to SSE
Time frame: Up to 13 weeks
Barriers to SSE
Time frame: Up to 13 weeks
SSE self-efficacy
Time frame: Up to 13 weeks
Level of worry about melanoma
Time frame: Up to 13 weeks
Number of health care consultations
Time frame: Up to 13 weeks
Barriers and facilitators to using mySmart check
Time frame: Up to 13 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Derived from this study: PubMed 34637495Manne 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon Manne, PhD principal investigator
Rutgers Cancer Institute of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, mySmartCheck and Survey Administration in people with Dysplastic Nevus and Health Status Unknown, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of thorough skin-self examination (SSE) (time frame: Up to 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03725449, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.