- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04535492
Technology-Based Cancer Screening Intervention
Improving Cancer Screening Through A Tailored Technology-Based Intervention
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Breast Cancer Screening:
Inclusion Criteria: women 50-74 years old Exclusion Criteria: current breast cancer diagnosis, mastectomy
Colorectal Cancer Screening:
Inclusion Criteria: adults 50-74 years Exclusion Criteria: colorectal cancer diagnosis
Lung Cancer Screening:
Inclusion Criteria: adult 55-80 years old with 30 pack per year history who currently smoke or quit within the last 15 years.
Exclusion Criteria: lung cancer diagnosis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Colorectal Cancer Screening Recommended
The USPSTF recommends screening for colorectal cancer starting at age 50 years and continuing until age 75 years.
|
Primary care practices randomized in a stepped wedge cluster design will implement a newly developed predictive model and analytic tool to improve shared decision-making for patients.
|
Other: Lung Cancer Screening Recommended
The USPSTF recommends annual screening for lung cancer with low-dose computed tomography (LDCT) in adults ages 50 to 80 years who have a 20 pack-year smoking history and currently smoke or have quit within the past 15 years.
|
Primary care practices randomized in a stepped wedge cluster design will implement a newly developed predictive model and analytic tool to improve shared decision-making for patients.
|
Other: Breast Cancer Screening Recommended
The USPSTF recommends biennial screening mammography for women aged 50 to 74 years.
|
Primary care practices randomized in a stepped wedge cluster design will implement a newly developed predictive model and analytic tool to improve shared decision-making for patients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of successful completion of breast cancer screening noted via electronic health record having mammogram result for the patient.
Time Frame: Duration of the study, a total of five years.
|
Successful completion rate per practice involved, based on eligible patients.
|
Duration of the study, a total of five years.
|
Rate of successful completion of lung cancer screening noted via electronic health record having low dose computed tomography of the chest result for the patient.
Time Frame: Duration of the study, a total of five years.
|
Successful completion rate per practice involved, based on eligible patients.
|
Duration of the study, a total of five years.
|
Rate of successful completion of colorectal cancer screening noted via electronic health record having colonoscopy, fecal occult blood, or non invasive screening option result for the patient.
Time Frame: Duration of the study, a total of five years.
|
Successful completion rate per practice involved, based on eligible patients.
|
Duration of the study, a total of five years.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average score of patient experience and satisfaction as assessed via Likert scale survey.
Time Frame: Duration of the study, a total five years.
|
A 23 item survey with Likert scale question is used to compiled the patient response: 23 is the lowest score and represent dissatisfaction and 115 is the highest score and represent satisfaction.
Participants will have the option to enter text for qualitative feedback and analysis.
|
Duration of the study, a total five years.
|
Average score of clinician experience and satisfaction as assessed via Likert scale survey.
Time Frame: Duration of the study, a total five years.
|
A 20 item survey with Likert scale question is used to compiled the patient response: 20 is the lowest score and represent dissatisfaction and 100 is the highest score and represent satisfaction.
Participants will have the option to enter text for qualitative feedback and analysis.
|
Duration of the study, a total five years.
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Vanessa Diaz, MD, Medical University of South Carolina
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 (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00101494
- 1R61AG068951 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ANALYTIC_CODE
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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