Clinical trial NCT05373823: MySmartSkin Online Skin Self-exam Intervention for Melanoma Survivors
Official title: A Digital Intervention to Improve Skin Self-examination Among Melanoma Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Melanoma
Keywords: Self-Examination
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-05-13
Enrollment: 385
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: SCREENING

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Body parts examined
timeFrame: Baseline
measure: Body parts examined
timeFrame: 3 months
measure: Body parts examined
timeFrame: 6 months
measure: Body parts examined
timeFrame: 12 months
measure: Body parts examined
timeFrame: 18 months
Secondary outcomes:
measure: Melanoma Diagnosis
timeFrame: 6 months
measure: Melanoma Diagnosis
timeFrame: 12 months
measure: Melanoma Diagnosis
timeFrame: 18 months
measure: Melanoma Stage
timeFrame: 3 months
measure: Melanoma Stage
timeFrame: 6 months
measure: Melanoma Stage
timeFrame: 12 months
measure: Melanoma Stage
timeFrame: 18 months
measure: Melanoma Diagnosis Date
timeFrame: 3 months
measure: Melanoma Diagnosis Date
timeFrame: 6 months
measure: Melanoma Diagnosis Date
timeFrame: 12 months
measure: Melanoma Diagnosis Date
timeFrame: 18 months
measure: Melanoma Diagnosis
timeFrame: 3 months
Other outcomes:
measure: Age
timeFrame: Baseline
measure: Sex
timeFrame: Baseline
measure: Race/Ethnicity
timeFrame: Baseline
measure: Education
timeFrame: Baseline
measure: Marital Status
timeFrame: Baseline
measure: State Residing In
timeFrame: Baseline
measure: Employment
timeFrame: Baseline
measure: Income
timeFrame: Baseline
measure: Health Insurance
timeFrame: Baseline
measure: Date of Diagnosis
timeFrame: Baseline
measure: Stage
timeFrame: Baseline
measure: Treatment Received
timeFrame: Baseline
measure: Indoor UV Tanning
timeFrame: 12 months
measure: Family History of Melanoma
timeFrame: Baseline
measure: Month of Assessment
timeFrame: Baseline
measure: Month of Assessment
timeFrame: 3 months
measure: Month of Assessment
timeFrame: 6 months
measure: Month of Assessment
timeFrame: 12 months
measure: Month of Assessment
timeFrame: 18 months
measure: Location of Assessment
timeFrame: Baseline
measure: Location of Assessment
timeFrame: 3 months
measure: Location of Assessment
timeFrame: 6 months
measure: Location of Assessment
timeFrame: 12 months
measure: Location of Assessment
timeFrame: 18 months
measure: Average UV Index
timeFrame: Baseline
measure: Average UV Index
timeFrame: 3 months
measure: Average UV Index
timeFrame: 6 months
measure: Average UV Index
timeFrame: 12 months
measure: Average UV Index
timeFrame: 18 months
Locations:
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Sharon Manne, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rutgers Cancer Institute of New Jersey
name: Carolyn Heckman, PhD
role: PRINCIPAL_INVESTIGATOR
References: