A Digital Intervention to Improve Skin Self-examination Among Melanoma Survivors

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
New Jersey
Rutgers Cancer Institute of New Jersey
RECRUITING
New Brunswick
Contact Information
Primary
Sharon Manne, PhD
mannesl@cinj.rutgers.edu
732-235-6759
Backup
Carolyn Heckman, PhD
ch842@cinj.rutgers.edu
732-266-9514
Time Frame
Start Date: 2023-03-06
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 385
Treatments
Experimental: Enhance MSS using multi-level stakeholder collaboration (Mo.1-15)
Enhancements of MSS to increase intervention effects - theory - based strategies (PHM), (BCT)
Experimental: 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
Active_comparator: 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
Authors
Sharon Manne
Related Therapeutic Areas
Sponsors
Leads: Rutgers, The State University of New Jersey
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov