Technology-Based Cancer Screening Intervention

NCT04535492 | Withdrawn

• 2 other identifiers: 001014941R61AG068951
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Lung Cancer; Breast Cancer

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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 Outcomes (2)

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

  Duration of the study, a total five years.

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

  Duration of the study, a total five years.

Study Arms (3)

Colorectal Cancer Screening Recommended

OTHER

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

Behavioral: Decision Making Support Tool

Lung Cancer Screening Recommended

OTHER

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.

Behavioral: Decision Making Support Tool

Breast Cancer Screening Recommended

OTHER

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

Behavioral: Decision Making Support Tool

Interventions

Decision Making Support Tool BEHAVIORAL

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.

Breast Cancer Screening Recommended; Colorectal Cancer Screening Recommended; Lung Cancer Screening Recommended

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Colorectal Cancer Screening:
• Lung Cancer Screening:

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Lung Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Vanessa Diaz, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 2, 2020
• Study Start: January 4, 2022
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: From the end of the study, July 2025, to July 2030.

Locations

US (1)