NCT05373823

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
385

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Mar 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Mar 2023Mar 2027

First Submitted

Initial submission to the registry

April 28, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 13, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

March 6, 2023

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

July 28, 2026

Status Verified

July 1, 2026

Enrollment Period

3.8 years

First QC Date

April 28, 2022

Last Update Submit

July 27, 2026

Conditions

Melanoma

Keywords

Self-Examination

Outcome Measures

Primary Outcomes (5)

  • 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).

    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).

    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).

    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).

    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).

    18 months

Secondary Outcomes (12)

  • Melanoma Diagnosis

    6 months

  • Melanoma Diagnosis

    12 months

  • Melanoma Diagnosis

    18 months

  • Melanoma Stage

    3 months

  • Melanoma Stage

    6 months

  • +7 more secondary outcomes

Other Outcomes (29)

  • Age

    Baseline

  • Sex

    Baseline

  • Race/Ethnicity

    Baseline

  • +26 more other outcomes

Study Arms (3)

Enhance MSS using multi-level stakeholder collaboration (Mo.1-15)

EXPERIMENTAL

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

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

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

Other: Assess implementation outcomes

Interventions

MySmartSkin enhancementOTHER

Focuses on MySmartSkin web application/intervention including enhancements using stakeholder collaboration and input

Enhance MSS using multi-level stakeholder collaboration (Mo.1-15)
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

Involves the longitudinal RCT comparing behavioral outcomes and effectiveness (Mo.16 -60)
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.

Aim 3: Assess implementation outcomes, identify factors relevant for future scale-up (Mo.17-60)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

RECRUITING

MeSH Terms

Conditions

MelanomaSelf-Examination

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesHealth BehaviorBehavior

Study Officials

  • Sharon Manne, PhD

    Rutgers Cancer Institute of New Jersey

    PRINCIPAL INVESTIGATOR

  • Carolyn Heckman, PhD

    Rutgers Cancer Institute of New Jersey

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharon Manne, PhD

CONTACT

732-235-6759mannesl@cinj.rutgers.edu

Carolyn Heckman, PhD

CONTACT

732-266-9514ch842@cinj.rutgers.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
SEQUENTIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Director for Cancer Prevention, Control and Population Science

Study Record Dates

First Submitted

April 28, 2022

First Posted

May 13, 2022

Study Start

March 6, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 31, 2027

Last Updated

July 28, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)