Technology-Based Cancer Screening Intervention

Medical University of South Carolina (MUSC) logo

Medical University of South Carolina (MUSC)

Status

Withdrawn

Conditions

Breast Cancer
Lung Cancer
Colorectal Cancer

Treatments

Behavioral: Decision Making Support Tool

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04535492
1R61AG068951 (U.S. NIH Grant/Contract)
00101494

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

50 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

0 participants in 3 patient groups

Colorectal Cancer Screening Recommended
Other group
Description:
The USPSTF recommends screening for colorectal cancer starting at age 50 years and continuing until age 75 years.
Treatment:
Behavioral: Decision Making Support Tool
Lung Cancer Screening Recommended
Other group
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.
Treatment:
Behavioral: Decision Making Support Tool
Breast Cancer Screening Recommended
Other group
Description:
The USPSTF recommends biennial screening mammography for women aged 50 to 74 years.
Treatment:
Behavioral: Decision Making Support Tool

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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