search
Back to results

Enhancing Skin Cancer Early Detection and Treatment in Primary Care

Primary Purpose

Cutaneous Melanoma

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Training and Education
Sponsored by
OHSU Knight Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cutaneous Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Two Oregon Health & Science University (OHSU) primary care pods at two clinics will be assigned to receive exposure to the melanoma early detection intervention Clinicians at the two clinics who are in pods that are not assigned to 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

Sites / Locations

  • OHSU Knight Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Comparison group

Other, Pragmatic

Arm Description

PCPs at the two clinics who are in pods that are not assigned to receive the intervention will serve as study comparators. Comparison group has no exposure to the group or online training sessions.

PCP participants complete group training and online training sessions. 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.

Outcomes

Primary Outcome Measures

Reach of the educational intervention
Measured by proportion of clinicians invited to participate in the educational intervention that complete the training modules and utilize dot phases and smart tools in EHR
Clinician knowledge in screening for skin cancer
Change in knowledge based upon survey questions prior to training and post-training.
Use of risk assessment tool
Measured through electronic health record (EHR) data.

Secondary Outcome Measures

Identification of suspicious lesions
Measured through EHR data.

Full Information

First Posted
December 29, 2022
Last Updated
September 21, 2023
Sponsor
OHSU Knight Cancer Institute
Collaborators
Oregon Health and Science University, National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT05675709
Brief Title
Enhancing Skin Cancer Early Detection and Treatment in Primary Care
Official Title
Enhancing Skin Cancer Early Detection and Treatment in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 25, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
OHSU Knight Cancer Institute
Collaborators
Oregon Health and Science University, National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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 and online training sessions. 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 are in pods that are not assigned to receive the intervention will serve as study comparators. Comparison group has no direct exposure to the group or online training sessions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Melanoma

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Comparison group
Arm Type
No Intervention
Arm Description
PCPs at the two clinics who are in pods that are not assigned to receive the intervention will serve as study comparators. Comparison group has no exposure to the group or online training sessions.
Arm Title
Other, Pragmatic
Arm Type
Experimental
Arm Description
PCP participants complete group training and online training sessions. 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.
Intervention Type
Behavioral
Intervention Name(s)
Training and Education
Intervention Description
Undergo group and online trainings
Primary Outcome Measure Information:
Title
Reach of the educational intervention
Description
Measured by proportion of clinicians invited to participate in the educational intervention that complete the training modules and utilize dot phases and smart tools in EHR
Time Frame
6 months
Title
Clinician knowledge in screening for skin cancer
Description
Change in knowledge based upon survey questions prior to training and post-training.
Time Frame
6 months
Title
Use of risk assessment tool
Description
Measured through electronic health record (EHR) data.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Identification of suspicious lesions
Description
Measured through EHR data.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Two Oregon Health & Science University (OHSU) primary care pods at two clinics will be assigned to receive exposure to the melanoma early detection intervention Clinicians at the two clinics who are in pods that are not assigned to 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan A Flocke, Ph.D.
Organizational Affiliation
OHSU Knight Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
OHSU Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Enhancing Skin Cancer Early Detection and Treatment in Primary Care

We'll reach out to this number within 24 hrs