Technology-Based Cancer Screening Intervention
May 9, 2023 updated by: Vanessa Diaz, Medical University of South Carolina
Improving Cancer Screening Through A Tailored Technology-Based Intervention
The primary purpose of this research study is to contribute to generalized knowledge on how to increase screening for patients at risk of missing their recommended cancer preventive care by using a newly developed predictive model and analytic tool to improve shared decision-making for these patients.
The goal of the clinical trial is to evaluate (prove) the effectiveness of this shared-decision making support tool developed in EPIC on the rate of recommended cancer screening in practice.
It contributes to knowledge on what specific methods can increase patient adherence to recommended preventive care and reduce disparities.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
Patients seen at primary care practices, who have been pre-determined to have unmet screening requirements and have received standard of care with a QI tool, will be asked to complete an optional questionnaire electronically through a patient portal or via a link sent by text within a week of their visit, based on their preference.
Only those who have indicated they agree to be contacted for research purposes will be contacted.
Surveys will be distributed through REDCap so no identifying information will be contained in the answers.
REDCap is a free, HIPAA compliant interface for building and managing online databases.
Additionally, surveys will be sent via mail if the patient cannot be reached electronically.
Survey responses received through the mail will not include any identifying information.
Pre-paid return envelopes will be provided to preserve anonymity.
Although a small proportion of South Carolina's population are primary Spanish speakers (about 4%), to be inclusive we want to ensure all materials are available in Spanish.
To remove barriers to participation, those needing physical, hearing, and visual assistance will be able to review and complete documents at the time of their clinic visit with the assistance of trained study personnel.
Invitations will continue to be sent out until 100 total patient responses are received per practice in the pragmatic trial, or 50 per practice in the pilot.
Clinicians will also receive a survey to assess the tool.
Recruitment for clinicians surveys will be done via email sent by the practice managers to the providers who have agreed to use the QI tool.
Clinician assessments will be delivered electronically via a link delivery by email or text, or sent by mail, based on clinician preference.
Respondents will be reimbursed for their time and effort.
These assessments will be anonymous.
Survey participation will be coded in order to provide compensation.
Since data will be identified only by code numbers (participant IDs) the master list of those codes will be kept physically separate from the collected data.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Vanessa Diaz, MD, Medical University of South Carolina
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 4, 2022
Primary Completion (Actual)
June 30, 2022
Study Completion (Actual)
June 30, 2022
Study Registration Dates
First Submitted
August 27, 2020
First Submitted That Met QC Criteria
August 27, 2020
First Posted (Actual)
September 2, 2020
Study Record Updates
Last Update Posted (Estimate)
May 11, 2023
Last Update Submitted That Met QC Criteria
May 9, 2023
Last Verified
May 1, 2023
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)?
YES
IPD Plan Description
Dataverse, an open source research data repository, will be used to archive and share de-identified participant data.
IPD Sharing Time Frame
From the end of the study, July 2025, to July 2030.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.