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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the MySmartSkin treatment for melanoma?

The research on immune checkpoint inhibitors (ICIs) shows they are effective in treating melanoma, and similar treatments are being explored for non-melanoma skin cancers. This suggests that treatments like MySmartSkin, which may involve similar approaches, could potentially be effective for melanoma. ^{1 2 3 4 5}

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Increasing melanoma incidence and survival trend shifts with improved melanoma-specific survival between 1990 and 2020 in Sweden. [2023]

2. Ireland pubmed.ncbi.nlm.nih.gov

Image-guided superficial radiation therapy has superior 2-year recurrence probability to Mohs micrographic surgery. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Sentinel lymph node biopsy in melanoma: final results of MSLT-I. [2018]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Towards less mutilating treatments in patients with advanced non-melanoma skin cancers by earlier use of immune checkpoint inhibitors. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Second nonmelanoma skin cancer in Spain: frequency and chronology. [2014]