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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-09484 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| STUDY00024809 | Other Identifier | OHSU Knight Cancer Institute | |
| P50CA244289 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Oregon Health and Science University | OTHER |
| National Cancer Institute (NCI) | NIH |
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Skin cancer screening may help find melanoma sooner, when it may be easier to treat. If found early melanoma and other types of skin cancer may be curable. Multi-component education may be an effective method to help primary care physicians (PCPs) learn about skin cancer screening. This clinical trial examines whether a clinician-focused educational intervention can improve PCP's knowledge and clinical performance to identify and triage skin cancer. This intervention may increase the PCP's ability to diagnose, treat and/or triage early-stage melanoma.
PRIMARY OBJECTIVE:
I. Evaluate whether a multi-component education strategy improves the ability of PCPs to identify and triage skin cancer.
OUTLINE:
Participants are assigned to 1 of 2 groups.
PCP participants complete group training. All training participants will also be offered series of short booster teaching points delivered virtually. Participants who complete the training also take part in pre-post knowledge assessments. PCP participants may also participate in a qualitative interview.
PCPs at the two clinics who do not receive the group training will serve as study comparators.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Comparison group | No Intervention | PCPs at the two clinics who do not receive the group training will serve as study comparators. | |
| Other, Pragmatic | Experimental | PCP participants complete group training. All training participants will also be offered series of short booster teaching points delivered virtually. Participants who complete the training also take part in pre-post knowledge assessments. PCP participants may also participate in a qualitative interview. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Training and Education | Behavioral | Undergo group trainings |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinician Knowledge in Melanoma Risk and Lesion Identification | KnChange in melanoma risk, knowledge based upon survey questions prior to training and post-training. Content covered melanoma risk, knowledge of electronic health record tools specific to the training and lesion identification and biopsy procedure knowledge. A total score of correct responses for the 27 items was generated and transformed to represent the percent of correct items with zero being no correct items and 100% being all items correct. A change score from pre-training to post-training was generated where a positive change score represented the gain in knowledge in percent points and a negative change score representing a lower percent of correct responses from pre-training to post-training. | Immediately before and after the training session |
| Dermatology Referral | Mean percent of dermatology referrals per 1000 patients | minimum of 3 months and up to 1 year of EHR data for each clinician prior to the start of the training and the same months in the year post-training. |
| Use of Dermatology E-consults | number of dermatology e-consults | minimum of 3 months and up to 1 year of EHR data for each clinician prior to the start of the training and the same months in the year post-training. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan A Flocke, Ph.D. | OHSU Knight Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OHSU Knight Cancer Institute | Portland | Oregon | 97239 | United States |
No plan is needed
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Forty-five clinicians (physicians, PAs, and NPs) received an email inviting them to participate in the MelaNOma training. Seventeen participated in the training. A total of 37 clinicians who weren't invited or chose not to participate in the MelaNOma training session were assigned to the comparator group. The total study sample size is 54.
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| ID | Title | Description |
|---|---|---|
| FG000 | Melanoma Training Group | MelaNOma included a 40-minute hybrid training co-led by a family medicine physician and a dermatologist |
| FG001 | Comparison Group | Clinicians from the same 2 clinics who weren't invited or chose not to participate in the MelaNOma training session |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Comparison Group | PCPs at the two clinics who do not receive the group training will serve as study comparators. |
| BG001 | Training Group | PCP participants complete group training. All training participants will also be offered series of short booster teaching points delivered virtually. Participants who complete the training also take part in pre-post knowledge assessments. PCP participants may also participate in a qualitative interview. Training and Education: Undergo group trainings |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Clinician Knowledge in Melanoma Risk and Lesion Identification | KnChange in melanoma risk, knowledge based upon survey questions prior to training and post-training. Content covered melanoma risk, knowledge of electronic health record tools specific to the training and lesion identification and biopsy procedure knowledge. A total score of correct responses for the 27 items was generated and transformed to represent the percent of correct items with zero being no correct items and 100% being all items correct. A change score from pre-training to post-training was generated where a positive change score represented the gain in knowledge in percent points and a negative change score representing a lower percent of correct responses from pre-training to post-training. | Knowledge was assessed before and after the training session for those clinicians who attended the training. We conducted a paired t-test | Posted | Mean | Standard Deviation | score on a scale | Immediately before and after the training session |
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Adverse event data from exposure to the training module was collected over 12 months.
Adverse events to participating in the educational training module was assessed using a post training survey and during qualitative interviews with the 11 clinicians who agreed to participate in a debriefing interview.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Comparison group | PCPs at the two clinics who do not receive the group training will serve as study comparators. |
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The initial plan to randomize pods of clinicians within each of the two clinics proved not to be feasible and participation in the training module was much lower than expected.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan Flocke | Oregon Health & Science University | 503 494 4404 | fmresrch@ohsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 23, 2023 | Jun 27, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 1, 2025 | Jun 27, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Comparison group |
PCPs at the two clinics who do not receive the group training will serve as study comparators. |
| OG001 | Training group | PCP participants complete group training. All training participants will also be offered series of short booster teaching points delivered virtually. Participants who complete the training also take part in pre-post knowledge assessments. PCP participants may also participate in a qualitative interview. Training and Education: Undergo group trainings |
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| Primary | Dermatology Referral | Mean percent of dermatology referrals per 1000 patients | Posted | Mean | Standard Deviation | percent per 1000 patients | minimum of 3 months and up to 1 year of EHR data for each clinician prior to the start of the training and the same months in the year post-training. |
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| Primary | Use of Dermatology E-consults | number of dermatology e-consults | Posted | Mean | Standard Deviation | percent per 1000 patients | minimum of 3 months and up to 1 year of EHR data for each clinician prior to the start of the training and the same months in the year post-training. |
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| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Training group | PCP participants complete group training. All training participants will also be offered series of short booster teaching points delivered virtually. Participants who complete the training also take part in pre-post knowledge assessments. PCP participants may also participate in a qualitative interview. Training and Education: Undergo group trainings | 0 | 17 | 0 | 17 | 0 | 17 |
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| 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 |