MelanomaNCT05373823
MySmartSkin Online Skin Self-exam Intervention for Melanoma Survivors
A study testing MySmartSkin enhancement, Educational webpage on Skin Self-Examination and Assess implementation outcomes in people with Melanoma, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
This project, mySmartSkin (MSS), includes an innovative Type 1 hybrid effectiveness-implementation trial designed to enhance the effects of MSS and simultaneously assess key implementation outcomes (e.g., cost, adoption) as well as contextual factors important for scale-up in community and health care settings where… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- MySmartSkin enhancement, Educational webpage on Skin Self-Examination and Assess implementation outcomes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 385 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2023to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of primary pathologic stage 0-III cutaneous malignant melanoma
- Three months to five years post-surgery
- No current evidence of cancer
- Not adherent to thorough SSE (i.e., did not check entire body at least once during the past three months)
- ≥ 18 years old
- Internet access
- Able to speak/read English
- Able to provide informed consent
Who cannot join
- Children
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
Sharon Manne, PhD, 732-235-6759, Sharon.Manne@rutgers.edu
About this study
Official title: A Digital Intervention to Improve Skin Self-examination Among Melanoma Survivors
This project, mySmartSkin (MSS), includes an innovative Type 1 hybrid effectiveness-implementation trial designed to enhance the effects of MSS and simultaneously assess key implementation outcomes (e.g., cost, adoption) as well as contextual factors important for scale-up in community and health care settings where melanoma survivors receive follow-up care. A type 1 hybrid effectiveness-implementation design allows us to engage multilevel stakeholders throughout this process, evaluate the effectiveness of the enhanced MSS, and identify critical factors for wide-scale implementation. Aim 1 will focus on enhancing the previous version of MSS by collaborating with multi-level stakeholders in qualitative interviews and usability testing. Aim 2 will evaluate the effects of enhanced MSS on thorough skin-self examinations (SSE) in a randomized-control trial (RCT) and examine its impact on the diagnosis of new/recurrent melanomas. Aim 3 will focus on assessing selected implementation outcomes and identify factors relevant to future scale-up for widespread dissemination and implementation.
Read the detailed description
This is a type one hybrid effectiveness-implementation study consisting of three aims. Aim one (Months 1-15) focuses on MSS enhancement using stakeholder collaboration. Aim two (Months 16-60) involves the longitudinal randomized control trial (RCT) comparing behavioral outcomes and effectiveness of enhanced MSS versus an educational webpage. Aim three (Months 16-60) will assess implementation outcomes and identify contextual factors to facilitate scale-up for future dissemination and implementation.
- Conditions
- Melanoma
- Being tested
- MySmartSkin enhancement, Educational webpage on Skin Self-Examination, Assess implementation outcomes
- Keywords
- Self-Examination
- Medical subject headings
- Melanoma, Self-Examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MySmartSkin enhancementOther
Focuses on MySmartSkin web application/intervention including enhancements using stakeholder collaboration and input
Educational webpage on Skin Self-ExaminationOther
Longitudinal RCT comparing behavioral outcomes and effectiveness of enhanced MSS versus an educational webpage on SSE as well as new recurrences/melanomas
Assess implementation outcomesOther
A mixed-methods study with multi-level stakeholders to assess implementation outcomes and identify contextual factors to facilitate scale-up for future dissemination and implementation.
| Study group | Role | What they receive |
|---|---|---|
| Enhance MSS using multi-level stakeholder collaboration (Mo.1-15) | Experimental | Enhancements of MSS to increase intervention effects - theory - based strategies (PHM), (BCT) Receives: Other: MySmartSkin enhancement |
| Involves the longitudinal RCT comparing behavioral outcomes and effectiveness (Mo.16 -60) | Experimental | RCT of enhanced MSS testing effectiveness (thorough SSE, sun protection behavior Involves the longitudinal RCT comparing behavioral outcomes and effectiveness of enhanced MSS versus an educational webpage on SSE as well as new recurrences/melanomas Receives: Other: Educational webpage on Skin Self-Examination |
| Aim 3: Assess implementation outcomes, identify factors relevant for future scale-up (Mo.17-60) | Active comparator | Assessment of implementation outcomes and key contextual factors from the perspective of multi - level stakeholders Receives: Other: Assess implementation outcomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body parts examined
Yes/No for a list of body parts examined during most recent SSE in the last three months. This is the primary outcome because SSE thoroughness is associated with detection of thinner tumors. This will be assessed by Reach, Effectiveness, Adoption, Implementation, and Maintenance(RE-AIM) and Practical, Robust Implementation and Sustainability Model (PRISM).
Measured: Baseline
Body parts examined
Yes/No for a list of body parts examined during most recent SSE in the last three months. This is the primary outcome because SSE thoroughness is associated with detection of thinner tumors. This will be assessed by Reach, Effectiveness, Adoption, Implementation, and Maintenance(RE-AIM) and Practical, Robust Implementation and Sustainability Model (PRISM).
Measured: 3 months
Body parts examined
Yes/No for a list of body parts examined during most recent SSE in the last three months. This is the primary outcome because SSE thoroughness is associated with detection of thinner tumors. This will be assessed by Reach, Effectiveness, Adoption, Implementation, and Maintenance(RE-AIM) and Practical, Robust Implementation and Sustainability Model (PRISM).
Measured: 6 months
Body parts examined
Yes/No for a list of body parts examined during most recent SSE in the last three months. This is the primary outcome because SSE thoroughness is associated with detection of thinner tumors. This will be assessed by Reach, Effectiveness, Adoption, Implementation, and Maintenance(RE-AIM) and Practical, Robust Implementation and Sustainability Model (PRISM).
Measured: 12 months
Body parts examined
Yes/No for a list of body parts examined during most recent SSE in the last three months. This is the primary outcome because SSE thoroughness is associated with detection of thinner tumors. This will be assessed by Reach, Effectiveness, Adoption, Implementation, and Maintenance(RE-AIM) and Practical, Robust Implementation and Sustainability Model (PRISM).
Measured: 18 months
Secondary outcomes (12)
Melanoma Diagnosis
This will be assessed by asking the participant at the second follow-up if a melanoma was diagnosed and confirmed by provider via medical records.
Measured: 6 months
Melanoma Diagnosis
This will be assessed by asking the participant at the third follow-up if a melanoma was diagnosed and confirmed by provider via medical records.
Measured: 12 months
Melanoma Diagnosis
This will be assessed by asking the participant at the fourth follow-up if a melanoma was diagnosed and confirmed by provider via medical records.
Measured: 18 months
Melanoma Stage
This will be assessed by asking the participant at the first follow-up what stage melanoma was diagnosed, if diagnosed. Response will be confirmed by provider via medical records.
Measured: 3 months
Melanoma Stage
This will be assessed by asking the participant at the second follow-up what stage melanoma was diagnosed, if diagnosed. Response will be confirmed by provider via medical records.
Measured: 6 months
Melanoma Stage
This will be assessed by asking the participant at the third follow-up what stage melanoma was diagnosed, if diagnosed. Response will be confirmed by provider via medical records.
Measured: 12 months
Melanoma Stage
This will be assessed by asking the participant at the fourth follow-up what stage melanoma was diagnosed, if diagnosed. Response will be confirmed by provider via medical records.
Measured: 18 months
Melanoma Diagnosis Date
This will be assessed by asking the participant at the first follow-up the date of his/her melanoma diagnosis, if diagnosed. Response will be confirmed by provider via medical records.
Measured: 3 months
Melanoma Diagnosis Date
This will be assessed by asking the participant at the second follow-up the date of his/her melanoma diagnosis, if diagnosed. Response will be confirmed by provider via medical records.
Measured: 6 months
Melanoma Diagnosis Date
This will be assessed by asking the participant at the third follow-up the date of his/her melanoma diagnosis, if diagnosed. Response will be confirmed by provider via medical records.
Measured: 12 months
Melanoma Diagnosis Date
This will be assessed by asking the participant at the fourth follow-up the date of his/her melanoma diagnosis, if diagnosed. Response will be confirmed by provider via medical records.
Measured: 18 months
Melanoma Diagnosis
This will be assessed by asking the participant at the first follow-up if a melanoma was diagnosed and confirmed by provider via medical records.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start6 Mar 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Type one hybrid effectiveness-implementation study consisting of three aims. Aim 1 (Months 1-15) focuses on MSS enhancement using stakeholder collaboration. Aim 2 (Months 16-60) involves the longitudinal RCT comparing behavioral outcomes and effectiveness of enhanced MSS versus an educational webpage on SSE as well as new recurrences/melanomas. Aim 3 (Months 16-60) is a mixed-methods study with multi-level stakeholders to assess implementation outcomes and identify contextual factors to facilitate scale-up for future dissemination and implementation. The figure below illustrates the integration of the PHM and implementation science frameworks with the study's aims.
- Masking
- None (open label)
- Enrolment
- 385 participants (estimated)
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 JerseyCarolyn Heckman, PhD, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05373823
- Sponsor's protocol ID
- CINJ132202
- Other IDs
- R01CA264548, Pro2022000948
- Status last verified
- Jul 2026
- First submitted
- 28 Apr 2022
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Digital Intervention to Improve Skin Self-examination Among Melanoma Survivors
- ClinicalTrials.gov ID
- NCT05373823
- Acronym / sponsor ID
- CINJ132202
- Conditions
- Melanoma
- Keywords
- Self-Examination
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 385 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 13 May 2022 (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 project, mySmartSkin (MSS), includes an innovative Type 1 hybrid effectiveness-implementation trial designed to enhance the effects of MSS and simultaneously assess key implementation outcomes (e.g., cost, adoption) as well as contextual factors important for scale-up in community and health care settings where melanoma survivors receive follow-up care. A type 1 hybrid effectiveness-implementation design allows us to engage multilevel stakeholders throughout this process, evaluate the effectiveness of the enhanced MSS, and identify critical factors for wide-scale implementation. Aim 1 will focus on enhancing the previous version of MSS by collaborating with multi-level stakeholders in qualitative interviews and usability testing. Aim 2 will evaluate the effects of enhanced MSS on thorough skin-self examinations (SSE) in a randomized-control trial (RCT) and examine its impact on the diagnosis of new/recurrent melanomas. Aim 3 will focus on assessing selected implementation outcomes and identify factors relevant to future scale-up for widespread dissemination and implementation.
Detailed description
This is a type one hybrid effectiveness-implementation study consisting of three aims. Aim one (Months 1-15) focuses on MSS enhancement using stakeholder collaboration. Aim two (Months 16-60) involves the longitudinal randomized control trial (RCT) comparing behavioral outcomes and effectiveness of enhanced MSS versus an educational webpage. Aim three (Months 16-60) will assess implementation outcomes and identify contextual factors to facilitate scale-up for future dissemination and implementation.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Type one hybrid effectiveness-implementation study consisting of three aims. Aim 1 (Months 1-15) focuses on MSS enhancement using stakeholder collaboration. Aim 2 (Months 16-60) involves the longitudinal RCT comparing behavioral outcomes and effectiveness of enhanced MSS versus an educational webpage on SSE as well as new recurrences/melanomas. Aim 3 (Months 16-60) is a mixed-methods study with multi-level stakeholders to assess implementation outcomes and identify contextual factors to facilitate scale-up for future dissemination and implementation. The figure below illustrates the integration of the PHM and implementation science frameworks with the study's aims.
| Arm | Type | Receives |
|---|---|---|
| Enhance MSS using multi-level stakeholder collaboration (Mo.1-15) | Experimental | Other: MySmartSkin enhancementEnhancements of MSS to increase intervention effects - theory - based strategies (PHM), (BCT) |
| Involves the longitudinal RCT comparing behavioral outcomes and effectiveness (Mo.16 -60) | Experimental | Other: Educational webpage on Skin Self-ExaminationRCT of enhanced MSS testing effectiveness (thorough SSE, sun protection behavior Involves the longitudinal RCT comparing behavioral outcomes and effectiveness of enhanced MSS versus an educational webpage on SSE as well as new recurrences/melanomas |
| Aim 3: Assess implementation outcomes, identify factors relevant for future scale-up (Mo.17-60) | Active comparator | Other: Assess implementation outcomesAssessment of implementation outcomes and key contextual factors from the perspective of multi - level stakeholders |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of primary pathologic stage 0-III cutaneous malignant melanoma
- Three months to five years post-surgery
- No current evidence of cancer
- Not adherent to thorough SSE (i.e., did not check entire body at least once during the past three months)
- ≥ 18 years old
Key exclusion criteria (1 listed)
- Children
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 |
|---|---|---|
| MySmartSkin enhancementFocuses on MySmartSkin web application/intervention including enhancements using stakeholder collaboration and input | Other | Enhance MSS using multi-level stakeholder collaboration (Mo.1-15) |
| Educational webpage on Skin Self-ExaminationLongitudinal RCT comparing behavioral outcomes and effectiveness of enhanced MSS versus an educational webpage on SSE as well as new recurrences/melanomas | Other | Involves the longitudinal RCT comparing behavioral outcomes and effectiveness (Mo.16 -60) |
| Assess implementation outcomesA mixed-methods study with multi-level stakeholders to assess implementation outcomes and identify contextual factors to facilitate scale-up for future dissemination and implementation. | Other | Aim 3: Assess implementation outcomes, identify factors relevant for future scale-up (Mo.17-60) |
Primary outcome
Body parts examined
Time frame: Baseline
Yes/No for a list of body parts examined during most recent SSE in the last three months. This is the primary outcome because SSE thoroughness is associated with detection of thinner tumors. This will be assessed by Reach, Effectiveness, Adoption, Implementation, and Maintenance(RE-AIM) and Practical, Robust Implementation and Sustainability Model (PRISM).
Body parts examined
Time frame: 3 months
Yes/No for a list of body parts examined during most recent SSE in the last three months. This is the primary outcome because SSE thoroughness is associated with detection of thinner tumors. This will be assessed by Reach, Effectiveness, Adoption, Implementation, and Maintenance(RE-AIM) and Practical, Robust Implementation and Sustainability Model (PRISM).
Body parts examined
Time frame: 6 months
Yes/No for a list of body parts examined during most recent SSE in the last three months. This is the primary outcome because SSE thoroughness is associated with detection of thinner tumors. This will be assessed by Reach, Effectiveness, Adoption, Implementation, and Maintenance(RE-AIM) and Practical, Robust Implementation and Sustainability Model (PRISM).
Body parts examined
Time frame: 12 months
Yes/No for a list of body parts examined during most recent SSE in the last three months. This is the primary outcome because SSE thoroughness is associated with detection of thinner tumors. This will be assessed by Reach, Effectiveness, Adoption, Implementation, and Maintenance(RE-AIM) and Practical, Robust Implementation and Sustainability Model (PRISM).
Body parts examined
Time frame: 18 months
Yes/No for a list of body parts examined during most recent SSE in the last three months. This is the primary outcome because SSE thoroughness is associated with detection of thinner tumors. This will be assessed by Reach, Effectiveness, Adoption, Implementation, and Maintenance(RE-AIM) and Practical, Robust Implementation and Sustainability Model (PRISM).
12 secondary outcomes
Melanoma Diagnosis
Time frame: 6 months
Melanoma Diagnosis
Time frame: 12 months
Melanoma Diagnosis
Time frame: 18 months
Melanoma Stage
Time frame: 3 months
Melanoma Stage
Time frame: 6 months
Melanoma Stage
Time frame: 12 months
Melanoma Stage
Time frame: 18 months
Melanoma Diagnosis Date
Time frame: 3 months
Melanoma Diagnosis Date
Time frame: 6 months
Melanoma Diagnosis Date
Time frame: 12 months
Melanoma Diagnosis Date
Time frame: 18 months
Melanoma Diagnosis
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Sharon Manne, PhD principal investigator
Rutgers Cancer Institute of New Jersey
Carolyn Heckman, 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 MySmartSkin enhancement, Educational webpage on Skin Self-Examination and Assess implementation outcomes in people with Melanoma, 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 8 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 28 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sharon Manne, PhD (732-235-6759, mannesl@cinj.rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body parts examined (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2026.