Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05373823

MySmartSkin Online Skin Self-exam Intervention for Melanoma Survivors

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Melanoma Behavior Health Behavior Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Self-Examination Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location status: Recruiting

Location contact

Sharon Manne, PhD

CONTACT

[email protected]

732-235-6759

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MySmartSkin enhancement

Other

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

Educational webpage on Skin Self-Examination

Other

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

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.

Primary outcomes

  1. Body parts examined

    Time frame: 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).

  2. Body parts examined

    Time frame: 3 months

    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).

  3. Body parts examined

    Time frame: 6 months

    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).

  4. Body parts examined

    Time frame: 12 months

    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).

  5. Body parts examined

    Time frame: 18 months

    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 outcomes

  1. Melanoma Diagnosis

    Time frame: 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.

  2. Melanoma Diagnosis

    Time frame: 12 months

    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.

  3. Melanoma Diagnosis

    Time frame: 18 months

    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.

  4. Melanoma Stage

    Time frame: 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.

  5. Melanoma Stage

    Time frame: 6 months

    This will be assessed by asking the participant at the second follow-up what stage melanoma was diagnosed, if diagnosed. Response will be confirmed by provider via medical records.

  6. Melanoma Stage

    Time frame: 12 months

    This will be assessed by asking the participant at the third follow-up what stage melanoma was diagnosed, if diagnosed. Response will be confirmed by provider via medical records.

  7. Melanoma Stage

    Time frame: 18 months

    This will be assessed by asking the participant at the fourth follow-up what stage melanoma was diagnosed, if diagnosed. Response will be confirmed by provider via medical records.

  8. Melanoma Diagnosis Date

    Time frame: 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.

  9. Melanoma Diagnosis Date

    Time frame: 6 months

    This will be assessed by asking the participant at the second follow-up the date of his/her melanoma diagnosis, if diagnosed. Response will be confirmed by provider via medical records.

  10. Melanoma Diagnosis Date

    Time frame: 12 months

    This will be assessed by asking the participant at the third follow-up the date of his/her melanoma diagnosis, if diagnosed. Response will be confirmed by provider via medical records.

  11. Melanoma Diagnosis Date

    Time frame: 18 months

    This will be assessed by asking the participant at the fourth follow-up the date of his/her melanoma diagnosis, if diagnosed. Response will be confirmed by provider via medical records.

  12. Melanoma Diagnosis

    Time frame: 3 months

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

Other outcomes

  1. Age

    Time frame: Baseline

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

  2. Sex

    Time frame: Baseline

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

  3. Race/Ethnicity

    Time frame: Baseline

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

  4. Education

    Time frame: Baseline

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

  5. Marital Status

    Time frame: Baseline

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

  6. State Residing In

    Time frame: Baseline

    This will be assessed by asking the participant what state he/she resides in the baseline survey.

  7. Employment

    Time frame: Baseline

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

  8. Income

    Time frame: Baseline

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

  9. Health Insurance

    Time frame: Baseline

    This will be assessed by asking the participant if he/she has health insurance coverage in the baseline survey.

  10. Date of Diagnosis

    Time frame: Baseline

    This will be assessed by asking the participant in the baseline survey the date that he/she was diagnosed with skin cancer.

  11. Stage

    Time frame: Baseline

    This will be assessed by asking the participant in the baseline survey the stage of cancer he/she was diagnosed with.

  12. Treatment Received

    Time frame: Baseline

    This will be assessed by asking the participant in the baseline survey what treatment he/she received.

  13. Indoor UV Tanning

    Time frame: 12 months

    This will be assessed by asking the participant in the baseline survey about his/her indoor UV tanning behaviors. Indoor UV tanning is an important covariate because it can pose as a risk factor for melanoma.

  14. Family History of Melanoma

    Time frame: Baseline

    This will be assessed by asking the participant in the baseline survey about his/her family history of melanoma. Family history is an important covariate because it can pose as a risk factor for melanoma.

  15. Month of Assessment

    Time frame: Baseline

    This will be assessed by asking participant in the baseline survey in what month he/she is completing the survey

  16. Month of Assessment

    Time frame: 3 months

    This will be assessed by asking participant in the first follow-up survey in what month he/she is completing the survey

  17. Month of Assessment

    Time frame: 6 months

    This will be assessed by asking participant in the second follow-up survey in what month he/she is completing the survey

  18. Month of Assessment

    Time frame: 12 months

    This will be assessed by asking participant in the third follow-up survey in what month he/she is completing the survey

  19. Month of Assessment

    Time frame: 18 months

    This will be assessed by asking participant in the fourth follow-up survey in what month he/she is completing the survey

  20. Location of Assessment

    Time frame: Baseline

    This will be assessed by asking participant in the baseline survey in what location he/she is completing the survey

  21. Location of Assessment

    Time frame: 3 months

    This will be assessed by asking participant in the first follow-up survey in what location he/she is completing the survey

  22. Location of Assessment

    Time frame: 6 months

    This will be assessed by asking participant in the second follow-up survey in what location he/she is completing the survey

  23. Location of Assessment

    Time frame: 12 months

    This will be assessed by asking participant in the third follow-up survey in what location he/she is completing the survey

  24. Location of Assessment

    Time frame: 18 months

    This will be assessed by asking participant in the fourth follow-up survey in what location he/she is completing the survey

  25. Average UV Index

    Time frame: Baseline

    Assessing the average UV index at solar noon over the 3 months prior to baseline survey submission. This will be determined by the study staff based on the month and location of assessment information provided by the participant in the baseline survey.

  26. Average UV Index

    Time frame: 3 months

    Assessing the average UV index at solar noon over the 3 months prior to the first follow-up survey submission. This will be determined by the study staff based on the month and location of assessment information provided by the participant in the first follow-up survey.

  27. Average UV Index

    Time frame: 6 months

    Assessing the average UV index at solar noon over the 3 months prior to the second follow-up survey submission. This will be determined by the study staff based on the month and location of assessment information provided by the participant in the second follow-up survey.

  28. Average UV Index

    Time frame: 12 months

    Assessing the average UV index at solar noon over the 3 months prior to the third follow-up survey submission. This will be determined by the study staff based on the month and location of assessment information provided by the participant in the third follow-up survey.

  29. Average UV Index

    Time frame: 18 months

    Assessing the average UV index at solar noon over the 3 months prior to the fourth follow-up survey submission. This will be determined by the study staff based on the month and location of assessment information provided by the participant in the fourth follow-up survey.

Study contacts

Contact information is provided by the study sponsor or research team.

Carolyn Heckman, PhD

CONTACT

[email protected]

732-266-9514

Sharon Manne, PhD

CONTACT

[email protected]

732-235-6759

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
May 13, 2022
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.