- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04789018
Enhanced Genetic Awareness and Genetic Evaluation for Men Through Technology, ENGAGEMENT Study
Enhanced Genetic Awareness and Genetic Evaluation for Men Through Technology ENGAGEMENT Study (Virtual Genetics Board)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVE:
I. To assess perceived usefulness of a virtual genetics board.
SECONDARY OBJECTIVE:
I. To assess acceptability/feasibility, perceived ease of use, self-efficacy for recommendations, genetics knowledge.
OUTLINE:
Participants complete a survey about genetic knowledge and self efficacy and then attend virtual genetics board. After virtual genetics board meeting, participants complete a second survey about perceived usefulness, ease of use, acceptability, feasibility, self-efficacy and genetic knowledge. Participants may also complete a semi-structured interview after virtual genetics board.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Individuals must meet one of the following inclusion criteria in order to be eligible to participate in the study:
- Healthcare providers (medical oncologists, radiation oncologists, urologists, primary care providers, mid-level providers) who evaluate, manage, or treat men with prostate cancer or screen men for prostate cancer.
- Providers who perform prostate cancer genetic testing for men (genetic counselors or healthcare providers)
- Scientists and researchers
- Advocacy or patient stakeholder organization members
Exclusion Criteria:
• Non-medical providers
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Observational (survey, virtual genetic board, interview)
Participants complete a survey about genetic knowledge and self efficacy and then attend virtual genetics board.
After virtual genetics board meeting, participants complete a second survey about perceived usefulness, ease of use, acceptability, feasibility, self-efficacy and genetic knowledge.
Participants may also complete a semi-structured interview after virtual genetics board.
|
Complete survey
Complete interview
Attend virtual genetics board
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Likert scaled perceived usefulness scores of the virtual genetics board
Time Frame: After virtual genetics board
|
Perceived usefulness will be judged against a benchmark mean score of 5/7.
|
After virtual genetics board
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Means or changes in means of Likert scaled acceptability/feasibility
Time Frame: Before and after virtual genetics board
|
Will be summarized by means, standard deviations, and 95% confidence intervals.
|
Before and after virtual genetics board
|
|
Perceived ease of use
Time Frame: After virtual genetics board
|
Will be summarized by means, standard deviations, and 95% confidence intervals.
|
After virtual genetics board
|
|
Self-efficacy for recommendations
Time Frame: Before and after virtual genetics board
|
Will be summarized by means, standard deviations, and 95% confidence intervals.
|
Before and after virtual genetics board
|
|
Change in mean scores on 17 genetics knowledge test questions
Time Frame: Baseline up to post-virtual genetics board
|
Will be summarized by means, standard deviations, and 95% confidence intervals.
|
Baseline up to post-virtual genetics board
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Amy Leader, DrPH, MPH, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
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
- Urogenital Diseases
- Genital Diseases
- Genital Neoplasms, Male
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Genital Diseases, Male
- Prostatic Diseases
- Male Urogenital Diseases
- Prostatic Neoplasms
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Health Services
- Health Care Facilities Workforce and Services
- Child Health Services
- Community Health Services
- Preventive Health Services
- Socioeconomic Factors
- Population Characteristics
- Methods
- Interviews as Topic
- Early Intervention, Educational
- Educational Status
Other Study ID Numbers
- 20F.936
- JT 16041 (Other Identifier: JeffTrial Number)
- 080-27000-X17501 (Other Grant/Funding Number: DOD)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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