MySmartSkin Online Skin Self-exam Intervention for Melanoma Survivors

NCT ID: NCT05373823

Last Updated: 2025-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

385 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-06

Study Completion Date

2027-03-31

Brief Summary

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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

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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

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Melanoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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.
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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

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

Group Type EXPERIMENTAL

MySmartSkin enhancement

Intervention Type OTHER

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

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

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 Type EXPERIMENTAL

Educational webpage on Skin Self-Examination

Intervention Type OTHER

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)

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

Group Type ACTIVE_COMPARATOR

Assess implementation outcomes

Intervention Type OTHER

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.

Interventions

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MySmartSkin enhancement

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

Intervention Type OTHER

Educational webpage on Skin Self-Examination

Longitudinal RCT comparing behavioral outcomes and effectiveness of enhanced MSS versus an educational webpage on SSE as well as new recurrences/melanomas

Intervention Type OTHER

Assess implementation outcomes

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Children
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Sharon Manne, PhD

Associate Director for Cancer Prevention, Control and Population Science

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sharon Manne, PhD

Role: PRINCIPAL_INVESTIGATOR

Rutgers Cancer Institute of New Jersey

Carolyn Heckman, PhD

Role: PRINCIPAL_INVESTIGATOR

Rutgers Cancer Institute of New Jersey

Locations

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Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sharon Manne, PhD

Role: CONTACT

732-235-6759

Carolyn Heckman, PhD

Role: CONTACT

732-266-9514

Facility Contacts

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Sharon Manne, PhD

Role: primary

732-235-6759

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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R01CA264548

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CINJ132202

Identifier Type: -

Identifier Source: org_study_id

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