Facilitators and Barriers to Cancer Screening: Stakeholder Perspectives on Implementation

Colorectal Cancer Screening Clinical Trial

Official title:

Facilitators and Barriers to Cancer Screening: Stakeholder Perspectives on Implementation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04683744
• Other study ID #: 2012926551
• Secondary ID: CDR-2018C3-14715
• Status: Recruiting
• Start date: January 11, 2021
• Est. completion date: July 2023

Study information

• Verified date: April 2021
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The rate of screening for colorectal cancer (CRC) in the U.S. remains low (under 65%), meaning that thousands of people die of colorectal cancer unnecessarily. Colorectal cancer screening tests range from more invasive and very sensitive for polyps and cancer (colonoscopy) to less invasive and less sensitive (e.g., fecal immunochemical testing (FIT)). Screening rates go up when patients consider all these tests, not just colonoscopy. Informing patients about their options for CRC screening could produce higher quality decisions, improve the match between patient preferences and tests performed, and increase uptake of CRC screening. Decision aids (DAs) are a promising tool for accomplishing this goal. Also, precision CRC prevention - providing information about an individual's specific risk for CRC

• has great promise to increase uptake and improve decision making.

Unfortunately, the COVID-19 pandemic is causing severe challenges to providing CRC screening and other prevention services. Health systems are trying to adapt, but these efforts have only begun and are poorly understood. Moreover, patient perceptions of disease risk and risk from COVID-19 are unknown.

Description:

The study team will engage with the leadership, staff, and providers in the study team's partner healthcare systems, to identify facilitators and barriers to implementing patient decision aids and provider notifications as well as cancer risk assessment tools, for colorectal cancer screening, and for other evidence-based cancer screening during the COVID pandemic and, potentially, after the conclusion of the pandemic.

At the conclusion of the study, the investigators will have extensive information regarding how best to provide decision aids through an electronic health record (EHR) portal, with or without personalized information, and to deliver provider notifications, which can guide broader implementation.

The study will involve interviews with staff and providers at the study team's partner healthcare systems to identify facilitators and barriers to implementing decision aids and provider notifications for colorectal cancer screening.

Also, the investigators will interview patients to identify perceptions of prevention during the COVID-19 pandemic including risk perception and barriers to screening, perceptions of risk from both the pandemic and disease, and patient cancer screening and risk prevention behaviors engaged in or postponed during the pandemic and patient rationales for their decisions. This part of the study will suggest potentially promising approaches for providing prevention and disease management during the COVID-19 pandemic.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Health system participants will be eligible if:

• they are employed by one of the study team's partner healthcare systems.

Patient participants will be eligible if:

• they have had a primary care visit during the past 24 months

• they have completed cancer screening during the past 5 years prior to 2020 for breast, cervical or lung cancer as noted in the electronic health record (EHR)

• age 50 years or older

• speaks English

• accessible by phone.

Exclusion Criteria:

Patients will be excluded if:

• they did not complete any cancer screening for breast, colon, cervical, or lung cancer during the past 5 years prior to 2020

• did not complete a primary care visit at a partner healthcare system during the past 2 years.

Related Conditions & MeSH terms

• Colorectal Cancer Screening
• Colorectal Neoplasms

Intervention

Other:
• Semi-structured interviews-Patients
The interview guide will consist of questions to elicit the patients thoughts about getting preventive healthcare during the COVID-19 pandemic, including perception of risk, barriers to getting healthcare, and information needed for decision making.
• Semi-structured interviews-Health system
The interview guide will consist of questions to elicit thoughts from health system leadership, providers, and staff about implementing decision aids, provider notifications, and cancer risk assessments in their health center or healthcare system. The questions may be specific to colorectal cancer screening or more generally about other cancer screenings. The investigators may also ask questions about cancer screening initiatives their health center or healthcare system engaged in during the COVID-19 pandemic.

Locations

Country	Name	City	State
United States	Indiana University	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify facilitators and barriers to implementing decision aids, provider notifications, and personal risk calculation using an electronic health record to promote colorectal cancer screening.	Semi-structured interviews with health system leadership, providers and staff conducted every 3-4 months	2 years
Primary	Identify the challenges and facilitators of effective cancer screening and prevention in primary care during the COVID-19 pandemic among leadership, providers, and staff.	Semi-structured interviews with health system leadership, providers, and staff	9 months
Primary	Identify patient knowledge, attitudes, and beliefs that influence decisions to engage in cancer screening and prevention during the COVID-19 pandemic, and barriers to uptake	Semi-structured interviews with primary care patients	1 day