Melanoma
Conditions
Keywords
Self-Examination
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.
Interventions
OTHERMySmartSkin enhancement
Focuses on MySmartSkin web application/intervention including enhancements using stakeholder collaboration and input
OTHEREducational 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
OTHERAssess 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.
Sponsors
Rutgers, The State University of New Jersey
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SCREENING
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body parts examined | Baseline | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Melanoma Diagnosis | 6 months | This will be assessed by asking the participant at the second follow-up if a melanoma was diagnosed and confirmed by provider via medical records. |
| Melanoma Stage | 3 months | This will be assessed by asking the participant at the first follow-up what stage melanoma was diagnosed, if diagnosed. Response will be confirmed by provider via medical records. |
| Melanoma Diagnosis Date | 3 months | This will be assessed by asking the participant at the first follow-up the date of his/her melanoma diagnosis, if diagnosed. Response will be confirmed by provider via medical records. |
Countries
United States
Contacts
CONTACTSharon Manne, PhD
CONTACTCarolyn Heckman, PhD
PRINCIPAL_INVESTIGATORSharon Manne, PhD
Rutgers Cancer Institute of New Jersey
PRINCIPAL_INVESTIGATORCarolyn Heckman, PhD
Rutgers Cancer Institute of New Jersey
Outcome results
None listed