Health TrialsbyHealthPanel

MySmartSkin Online Skin Self-exam Intervention for Melanoma Survivors

ConditionMelanoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRutgers, The State University of New Jersey

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Children

Trial design

Design model

Sequential

Treatments tested in this trial

  • MySmartSkin enhancement

    Other intervention

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

  • Educational webpage on Skin Self-Examination

    Other intervention

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

  • Assess implementation outcomes

    Other intervention

    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.

Treatment groups

385 Participants
are divided into 3 treatment groups
Group A: Enhance MSS using multi-level stakeholder collaboration (Mo.1-15)Experimental treatment 1 intervention
Group B: Involves the longitudinal RCT comparing behavioral outcomes and effectiveness (Mo.16 -60)Experimental treatment 1 intervention
Group C: Aim 3: Assess implementation outcomes, identify factors relevant for future scale-up (Mo.17-60)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Baseline
2

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).

Time frame
3 months
3

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).

Time frame
6 months
4

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).

Time frame
12 months

Secondary outcomes

1

Melanoma Diagnosis

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.

Time frame
6 months
2

Melanoma Diagnosis

This will be assessed by asking the participant at the third follow-up if a melanoma was diagnosed and confirmed by provider via medical records.

Time frame
12 months
3

Melanoma Diagnosis

This will be assessed by asking the participant at the fourth follow-up if a melanoma was diagnosed and confirmed by provider via medical records.

Time frame
18 months
4

Melanoma Stage

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.

Time frame
3 months

Other outcomes

1

Age

This will be assessed by asking the participant his/her age in the baseline survey.

Time frame
Baseline
2

Sex

This will be assessed by asking the participant his/her sex in the baseline survey.

Time frame
Baseline
3

Race/Ethnicity

This will be assessed by asking the participant his/her race and ethnicity in the baseline survey.

Time frame
Baseline
4

Education

This will be assessed by asking the participant his/her education level in the baseline survey.

Time frame
Baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rutgers, The State University of New Jersey

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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