MySmartSkin Renewal for Melanoma

Overseen By Carolyn Heckman, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Disqualifiers: Children

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

385 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve a tool called MySmartSkin (MSS) to assist melanoma survivors in conducting thorough skin self-examinations (SSE). The researchers aim to determine if the enhanced MSS leads to better self-checks and helps detect new or returning melanomas early. Participants will also assess how well this tool can be shared and used in real-world settings. Those who have had stage 0-III melanoma, are post-surgery with no current cancer signs, and have not been regularly checking their skin might be a good fit. Participants need internet access and must speak and read English.

As an unphased trial, this study offers participants the chance to contribute to innovative research that could improve melanoma monitoring for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the MySmartSkin enhancement is safe?

Research has shown that mySmartSkin (MSS) received positive feedback in past studies. These studies found that the MSS program, an online tool, helps individuals better check their skin for signs of melanoma, which is crucial for those with a history of melanoma.

No serious side effects have been reported from using MSS. Participants have not encountered major safety issues, indicating that MSS is generally well-tolerated. As a digital tool, MSS does not involve medication or medical procedures, reducing the risk of physical side effects.

Overall, MSS appears to be a safe and effective way to help individuals monitor their skin health after melanoma. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MySmartSkin Renewal method for melanoma because it aims to enhance self-examination and sun protection behaviors through multi-level stakeholder collaboration. Unlike traditional treatments that primarily focus on medical interventions like surgery or immunotherapy, this approach emphasizes behavioral strategies to prevent new occurrences and recurrences of melanoma. By comparing its effectiveness to educational web pages, this trial could revolutionize how we think about melanoma prevention and care.

What evidence suggests that this trial's treatments could be effective for melanoma?

Research has shown that the mySmartSkin (MSS) tool helps melanoma survivors perform better skin self-examinations (SSE). Regular skin checks are crucial for early detection of new or returning melanomas. Studies have found that MSS's digital features facilitate frequent skin checks. In this trial, one arm will test the enhanced MSS, designed to make these checks more thorough and effective. Another arm will compare the effectiveness of the enhanced MSS to an educational webpage on SSE. In past trials, the MSS program enabled users to perform more consistent and accurate SSEs. This suggests the enhanced MSS could be a valuable tool for improving skin-checking habits. ^{1 3 4 6 7}

Who Is on the Research Team?

Sharon L Manne, PhD

Principal Investigator

Rutgers Cancer Institute of New Jersey

Carolyn Heckman, PhD

Principal Investigator

Rutgers Cancer Institute of New Jersey

Are You a Good Fit for This Trial?

This trial is for adults over 18 who've had stage 0-III melanoma, are three months to five years post-surgery without current cancer evidence. Participants should have missed at least one full-body skin self-exam in the past three months and must have internet access and understand English.

Inclusion Criteria

My skin cancer is at an early to mid-stage.

I had surgery between 3 months and 5 years ago.

Able to provide informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enhancement Phase

Enhancement of the mySmartSkin (MSS) intervention using stakeholder collaboration

15 months

Randomized Control Trial (RCT)

Longitudinal RCT comparing behavioral outcomes and effectiveness of enhanced MSS versus an educational webpage

44 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 months

What Are the Treatments Tested in This Trial?

Interventions

• Assess implementation outcomes
• Educational webpage on SSE
• MSS enhancement

Trial Overview

The study tests an enhanced MySmartSkin (MSS) service with stakeholder feedback aimed at improving its reach and effectiveness. It includes an educational webpage on skin self-exams (SSE) and evaluates how well these tools help find new melanomas.

How Is the Trial Designed?

Group I: Involves the longitudinal RCT comparing behavioral outcomes and effectiveness (Mo.16 -60) Experimental Treatment 1 Intervention

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

Group II: Enhance MSS using multi-level stakeholder collaboration (Mo.1-15) Experimental Treatment 1 Intervention

Enhancements of MSS to increase intervention effects - theory - based strategies (PHM), (BCT)

Group III: Aim 3: Assess implementation outcomes, identify factors relevant for future scale-up (Mo.17-60) Active Control 1 Intervention

Assessment of implementation outcomes and key contextual factors from the perspective of multi - level stakeholders

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study comparing 2,286 non-melanoma skin cancers (NMSCs) treated with image-guided superficial radiation therapy (IGSRT) to 5,391 treated with Mohs micrographic surgery (MMS), IGSRT showed a statistically significantly lower 2-year recurrence probability (P < 0.001).

These results suggest that IGSRT is a more effective treatment option for early-stage NMSCs compared to MMS, indicating its potential as a preferred first-line therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image-guided superficial radiation therapy has superior 2-year recurrence probability to Mohs micrographic surgery. McClure, EM., Sedor, G., Jin, Y., et al.[2023]

The MSLT-I trial demonstrated that sentinel lymph node biopsy (SLNB) does not improve 10-year melanoma-specific survival compared to wide local excision (WLE) alone, as both groups had similar rates of nodal positivity (20.8%).

However, for patients with intermediate-thickness melanoma (1.2-3.5 mm Breslow depth) who had positive sentinel nodes, early intervention after SLNB significantly improved 10-year distant disease-free survival and melanoma-specific survival, indicating a potential benefit for this specific subgroup.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sentinel lymph node biopsy in melanoma: final results of MSLT-I. Durham, AB., Wong, SL.[2018]

Between 1990 and 2020, the 5-year melanoma-specific survival (MSS) rate in Sweden improved significantly, rising from 88.9% in 1990-2000 to 93.0% in 2011-2020, indicating better outcomes for patients over time.

The introduction of new systemic therapies for metastatic cutaneous melanoma around 2012 is likely linked to the observed improvements in MSS, with a notable reduction in the risk of death from melanoma across all age groups in the most recent diagnostic period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing melanoma incidence and survival trend shifts with improved melanoma-specific survival between 1990 and 2020 in Sweden. Vikström, S., Mikiver, R., Lapins, J., et al.[2023]

In a study of 926 patients with nonmelanoma skin cancer (NMSC) followed for an average of 81.9 months, 22.6% developed a subsequent nonmelanoma skin cancer (sNMSC) within a median time of 28.3 months, highlighting the common occurrence of sNMSC after initial NMSC diagnosis.

The study identified that patients aged 40 years and older and those whose first NMSC was excised from the limbs were at a higher risk of developing sNMSC, suggesting that these factors should be considered in follow-up care and guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Second nonmelanoma skin cancer in Spain: frequency and chronology. Domínguez-Cruz, JJ., Nieto-García, A., Rios, JJ., et al.[2014]

Immune checkpoint inhibitors (ICIs) show comparable response rates in advanced non-melanoma skin cancers (NMSC) and melanoma, suggesting their potential effectiveness in treating these rare cancers.

Early studies indicate that neoadjuvant ICI treatment can lead to complete responses in about half of patients with NMSC, potentially reducing the need for invasive local treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Towards less mutilating treatments in patients with advanced non-melanoma skin cancers by earlier use of immune checkpoint inhibitors. Hooiveld-Noeken, JS., Eggen, AC., Rácz, E., et al.[2022]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38345836

A Digital Intervention to Improve Skin Self-Examination Among ...

A web-based, fully automated intervention called mySmartSkin (MSS) that successfully improved SSE among survivors of melanoma.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05373823

MySmartSkin Online Skin Self-exam Intervention for ...

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 ...

3.

researchprotocols.org

researchprotocols.org/2024/1/e52689/

A Digital Intervention to Improve Skin Self-Examination ...

A web-based, fully automated intervention called mySmartSkin (MSS) that successfully improved SSE among survivors of melanoma.

4.

cancer.gov

cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-10799

mySmartSkin for the Improvement of Skin Self-Examination ...

This clinical trial seeks to improve the effects of mySmartSkin (MSS) and proactively identify barriers and facilitators in follow up care for melanoma ...

5.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT05373823/mysmartskin-online-skin-self-exam-intervention-for-melanoma-survivors

MySmartSkin Online Skin Self-exam Intervention for ...

This project, mySmartSkin (MSS), includes an innovative Type 1 hybrid effectiveness-implementation trial designed to enhance the effects of MSS ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8320885/

Randomized controlled trial of the mySmartSkin web ...

This study reports on the impact of an online intervention, called mySmartSkin (MSS), on engagement in SSE and sun protection behaviors among melanoma ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10897801/

A Digital Intervention to Improve Skin Self-Examination Among ...

A web-based, fully automated intervention called mySmartSkin (MSS) that successfully improved SSE among survivors of melanoma.