Technology-Based Cancer Screening Intervention

Breast Cancer Clinical Trial

Official title:

Improving Cancer Screening Through A Tailored Technology-Based Intervention

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04535492
• Other study ID #: 00101494
• Secondary ID: 1R61AG068951
• Status: Withdrawn
• Phase: N/A
• Start date: January 4, 2022
• Est. completion date: June 30, 2022

Study information

• Verified date: May 2023
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Colorectal Cancer
• Colorectal Neoplasms
• Lung Cancer

Intervention

Behavioral:
• Decision Making Support Tool
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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Duration of the study, a total of five years.
Primary	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.	Duration of the study, a total of five years.
Primary	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.	Duration of the study, a total of five years.
Secondary	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.	Duration of the study, a total five years.
Secondary	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.	Duration of the study, a total five years.