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Technology-Based Cancer Screening Intervention

Primary Purpose

Colorectal Cancer, Lung Cancer, Breast Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Decision Making Support Tool
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Cancer

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Colorectal Cancer Screening Recommended

Lung Cancer Screening Recommended

Breast Cancer Screening Recommended

Arm Description

The USPSTF recommends screening for colorectal cancer starting at age 50 years and continuing until age 75 years.

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.

The USPSTF recommends biennial screening mammography for women aged 50 to 74 years.

Outcomes

Primary Outcome Measures

Rate of successful completion of breast cancer screening noted via electronic health record having mammogram result for the patient.
Successful completion rate per practice involved, based on eligible patients.
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.
Successful completion rate per practice involved, based on eligible patients.
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.
Successful completion rate per practice involved, based on eligible patients.

Secondary Outcome Measures

Average score of patient experience and satisfaction as assessed via Likert scale survey.
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.
Average score of clinician experience and satisfaction as assessed via Likert scale survey.
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.

Full Information

First Posted
August 27, 2020
Last Updated
May 9, 2023
Sponsor
Medical University of South Carolina
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT04535492
Brief Title
Technology-Based Cancer Screening Intervention
Official Title
Improving Cancer Screening Through A Tailored Technology-Based Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Withdrawn
Why Stopped
No further funding
Study Start Date
January 4, 2022 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institute on Aging (NIA)

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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Lung Cancer, Breast Cancer

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Colorectal Cancer Screening Recommended
Arm Type
Other
Arm Description
The USPSTF recommends screening for colorectal cancer starting at age 50 years and continuing until age 75 years.
Arm Title
Lung Cancer Screening Recommended
Arm Type
Other
Arm Description
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.
Arm Title
Breast Cancer Screening Recommended
Arm Type
Other
Arm Description
The USPSTF recommends biennial screening mammography for women aged 50 to 74 years.
Intervention Type
Behavioral
Intervention Name(s)
Decision Making Support Tool
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of successful completion of breast cancer screening noted via electronic health record having mammogram result for the patient.
Description
Successful completion rate per practice involved, based on eligible patients.
Time Frame
Duration of the study, a total of five years.
Title
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.
Description
Successful completion rate per practice involved, based on eligible patients.
Time Frame
Duration of the study, a total of five years.
Title
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.
Description
Successful completion rate per practice involved, based on eligible patients.
Time Frame
Duration of the study, a total of five years.
Secondary Outcome Measure Information:
Title
Average score of patient experience and satisfaction as assessed via Likert scale survey.
Description
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.
Time Frame
Duration of the study, a total five years.
Title
Average score of clinician experience and satisfaction as assessed via Likert scale survey.
Description
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.
Time Frame
Duration of the study, a total five years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vanessa Diaz, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Technology-Based Cancer Screening Intervention

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