- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05675709
Enhancing Skin Cancer Early Detection and Treatment in Primary Care
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oregon
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Portland, Oregon, United States, 97239
- OHSU Knight Cancer Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Clinicians at two Oregon Health & Science University (OHSU) primary care clinics will be invited to receive exposure to the melanoma early detection intervention
- Clinicians at the two clinics who do not receive the intervention will serve as study comparators
- These individuals are all aged 18 years or older
- All practice members speak English
Exclusion Criteria:
- No one will be intentionally excluded
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Comparison group
PCPs at the two clinics who do not receive the group training will serve as study comparators.
|
|
|
Experimental: Other, Pragmatic
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.
|
Undergo group trainings
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Clinician Knowledge in Melanoma Risk and Lesion Identification
Time Frame: Immediately before and after the training session
|
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
Time Frame: 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.
|
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
Time Frame: 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.
|
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.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Identification of suspicious lesions
Time Frame: 3 months
|
Measured through EHR data.
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Susan A Flocke, Ph.D., OHSU Knight Cancer Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Neoplasms by Histologic Type
- Skin Diseases
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Skin Neoplasms
- Skin and Connective Tissue Diseases
- Melanoma
- Socioeconomic Factors
- Population Characteristics
- Educational Status
Other Study ID Numbers
- STUDY00024809 (Other Identifier: OHSU Knight Cancer Institute)
- NCI-2022-09484 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- P50CA244289 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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