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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA264548 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhance MSS using multi-level stakeholder collaboration (Mo.1-15) | Experimental | Enhancements of MSS to increase intervention effects - theory - based strategies (PHM), (BCT) |
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| Involves the longitudinal RCT comparing behavioral outcomes and effectiveness (Mo.16 -60) | Experimental | 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 |
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| Aim 3: Assess implementation outcomes, identify factors relevant for future scale-up (Mo.17-60) | Active Comparator | Assessment of implementation outcomes and key contextual factors from the perspective of multi - level stakeholders |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MySmartSkin enhancement | Other | Focuses on MySmartSkin web application/intervention including enhancements using stakeholder collaboration and input |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline |
| 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). | 3 months |
| 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). | 6 months |
| 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). | 12 months |
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Melanoma Diagnosis |
| Measure | Description | Time Frame |
|---|---|---|
| Age | This will be assessed by asking the participant his/her age in the baseline survey. | Baseline |
| Sex | This will be assessed by asking the participant his/her sex in the baseline survey. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sharon Manne, PhD | Contact | 732-235-6759 | mannesl@cinj.rutgers.edu | |
| Carolyn Heckman, PhD | Contact | 732-266-9514 | ch842@cinj.rutgers.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sharon Manne, PhD | Rutgers Cancer Institute of New Jersey | Principal Investigator |
| Carolyn Heckman, PhD | Rutgers Cancer Institute of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers Cancer Institute of New Jersey | Recruiting | New Brunswick | New Jersey | 08901 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 25, 2024 | Jul 1, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| D016353 | Self-Examination |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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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.
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| 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. |
|
| 18 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.
| 12 months |
| 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. | 18 months |
| 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. | 3 months |
| Melanoma Stage | 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 months |
| Melanoma Stage | 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. | 12 months |
| Melanoma Stage | 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. | 18 months |
| Melanoma Diagnosis Date | 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. | 3 months |
| Melanoma Diagnosis Date | 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. | 6 months |
| Melanoma Diagnosis Date | 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. | 12 months |
| Melanoma Diagnosis Date | 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. | 18 months |
| Melanoma Diagnosis | 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. | 3 months |
| Baseline |
| Race/Ethnicity | This will be assessed by asking the participant his/her race and ethnicity in the baseline survey. | Baseline |
| Education | This will be assessed by asking the participant his/her education level in the baseline survey. | Baseline |
| Marital Status | This will be assessed by asking the participant his/her marital status in the baseline survey. | Baseline |
| State Residing In | This will be assessed by asking the participant what state he/she resides in the baseline survey. | Baseline |
| Employment | This will be assessed by asking the participant his/her employment status in the baseline survey. | Baseline |
| Income | This will be assessed by asking the participant his/her income level in the baseline survey. | Baseline |
| Health Insurance | This will be assessed by asking the participant if he/she has health insurance coverage in the baseline survey. | Baseline |
| Date of Diagnosis | This will be assessed by asking the participant in the baseline survey the date that he/she was diagnosed with skin cancer. | Baseline |
| Stage | This will be assessed by asking the participant in the baseline survey the stage of cancer he/she was diagnosed with. | Baseline |
| Treatment Received | This will be assessed by asking the participant in the baseline survey what treatment he/she received. | Baseline |
| Indoor UV Tanning | 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. | 12 months |
| Family History of Melanoma | 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. | Baseline |
| Month of Assessment | This will be assessed by asking participant in the baseline survey in what month he/she is completing the survey | Baseline |
| Month of Assessment | This will be assessed by asking participant in the first follow-up survey in what month he/she is completing the survey | 3 months |
| Month of Assessment | This will be assessed by asking participant in the second follow-up survey in what month he/she is completing the survey | 6 months |
| Month of Assessment | This will be assessed by asking participant in the third follow-up survey in what month he/she is completing the survey | 12 months |
| Month of Assessment | This will be assessed by asking participant in the fourth follow-up survey in what month he/she is completing the survey | 18 months |
| Location of Assessment | This will be assessed by asking participant in the baseline survey in what location he/she is completing the survey | Baseline |
| Location of Assessment | This will be assessed by asking participant in the first follow-up survey in what location he/she is completing the survey | 3 months |
| Location of Assessment | This will be assessed by asking participant in the second follow-up survey in what location he/she is completing the survey | 6 months |
| Location of Assessment | This will be assessed by asking participant in the third follow-up survey in what location he/she is completing the survey | 12 months |
| Location of Assessment | This will be assessed by asking participant in the fourth follow-up survey in what location he/she is completing the survey | 18 months |
| Average UV Index | 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. | Baseline |
| Average UV Index | 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. | 3 months |
| Average UV Index | 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. | 6 months |
| Average UV Index | 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. | 12 months |
| Average UV Index | 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. | 18 months |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D015438 | Health Behavior |
| D001519 | Behavior |