Eliminating Barriers to Colorectal Cancer Screening Using Rapid Cycle Testing: A Pilot Study

November 12, 2025 updated by: Adjoa Anyane-Yeboa, M.D., Massachusetts General Hospital
The investigators will use a mixed methods study i.e. focus groups involving CHC staff as well as quantitative study which involves analyzing data that is available from the EHR and DRVS population management platform.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Aim 1: Describe the demographics of the populations aged 45 - 49, 50-4, and over 55 to understand baseline screening needs and disparities.

Overview: The investigators will characterize the population in these age groups in order to understand resources needed to screen patients at age 50 and to expand screening to the USPSTF's draft guideline if passed.

Setting: The investigators will select 4 CHCs with distinctly diverse populations for Aim 1 and Aim 2.

Approach: The investigators will examine data from the EHR and the DRVS platform to determine: (1) the size and demographics of the three age groups; (2) the frequency in which this population presents to the CHC for primary care and other visits; and (3) current screening initiation patterns. Based on the findings of the investigator's initial evaluation, the investigators will estimate the additional colorectal cancer screening tests that will be required to screen this population promptly at age 50 and the additional resources that will be needed at each health center to meet this need. The investigators will also estimate the impact of a lower age of screening initiation. Analysis will be stratified by race/ethnicity, gender, age and insurance status to assess for any disparities that might be present.

Data Collection and Management: The DRVS population management platform provides the data needed to evaluate Aim 1. The Implementation Science Center for Cancer Control Equity (ISCCCE) data management team will pull the data needed for the participating CHCs, once selected. The investigators have existing data use agreements that will be amended for this specific project. Data flows and management procedures have already been established and will serve to expedite this study.

Aim 2: Conduct focus groups with key personnel to identify barriers and facilitators to screening in 4 different health centers with uniquely diverse populations.

Overview: The investigators will conduct focus groups to understand barriers and facilitators to colorectal cancer screening including perceptions around the change in screening age, attitudes about specific strategies to facilitate colorectal cancer screening (e.g. use of technological-based solutions to prompt screening, task shifting with integration of medical assistants into the screening process), proposed strategies to improve screening at the health center, and other likely barriers and facilitators.

Approach: The investigators will conduct focus groups with key personnel at the 4 participating health centers. The investigators will include an administrative leader and population health managers, data analysts and quality improvement staff, as well as nurse/practice managers, medical assistants, and providers (MD, NP, and/or PA). Focus groups will address: (1) barriers and facilitators to timely screening initiation; (2) perceptions around using technological solutions to prompt colorectal cancer screening; and (3) perceptions about task-shifting with integration of the medical assistants into the colorectal cancer screening process. Distinct barriers and facilitators/determinants will be identified at the patient, provider and system-level. These determinants will be prioritized (high, medium, low) based on number of times referenced in the interviews.

Data Analysis: Focus group data will be analyzed to identify key themes related to barriers and facilitators to screening.

Outcomes: The outcome of this aim will be identified barriers and facilitators to colorectal cancer screening at health centers with a key focus on understanding perceptions around utilization of technological solutions (e.g. pre-existing text message platforms at health centers, electronic registries) and integration of the medical assistants into the CRC screening workflow.

Aim 3: Develop and test intervention components to anticipate and address barriers and facilitators at the patient, provider and system-level using rapid cycle methods.

Overview: We will identify implementation strategies at patient, provider and systems-levels and match to identified Aim 2 barriers and facilitators, use design probes to understand the workflows and preconditions for implementation strategies, and individually test strategies using rapid cycle methods.

Approach:

  • Development of Implementation Strategies: High ranking barriers from Aim 2 will be matched with implementation strategies that are most likely to influence implementation outcomes. A minimum of 2 implementation strategies will be developed at each level. When identifying strategies, we will consider the: (1) implementation strategy; (2) mechanism in which the strategy impacts the identified determinant (3) the determinant; (4) moderators that may influence the impact of the strategy; (5) the preconditions necessary for successful implementation; and (6) implementation outcomes affected.
  • Design Probes: We will conduct design probes to understand the culture, climate and preconditions to implementation at each health center. We will use design probes to further understand the day-to-day workings at the health center and workflows. We will further tailor our implementation strategies based on additional barriers and facilitators that are identified from design probes.
  • Rapid Cycle Testing: Individual strategies will be tested using single case experimental design (SCED). In SCED each subject serves as their own control, an intervention is systematically introduced and withdrawn, and the effects of the intervention are measured. For our study each CHC will serve as a separate subject. We will conduct a series of single case experiments at each CHC using component analysis to rapidly test and optimize our strategies. Component analysis allows researchers to assess several interventions or components of an intervention individually or as a treatment package in multiple assessments. A minimum of 2 strategies at each level (patient, provider, system) will be tested at each clinic site. For example, a patient-level strategy might include text messaging to patients, which is enabled by the DRVS platform. We might test whether single or multiple text messages around a patient's birthday can prompt screening uptake, or if messages prior to a health care visit increases uptake of screening offered. An example at the provider-level might include the impact of a motivational training if staff identify difficulty motivating patients as a barrier. A systems-level strategy might include incorporating CRC screening into the workflows of the health center using the medical assistants, if provider time limitations are identified as a barrier.
  • Post-Implementation Survey: When implementation testing ends, our team will send out a survey to any CHC staff member (administrative leader and population health managers, data analysts and quality improvement staff, as well as nurse/practice manager, medical assistant, and provider [MD, NP, and/or PA]) involved with the implementation of strategies at the health center level, and the survey information we will collect will assess perceptions on feasibility, appropriateness, and acceptability of the implementation strategy used.

Study Type

Interventional

Enrollment (Estimated)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02124
        • Recruiting
        • Codman Square Health Center
        • Contact:
          • Stephen Tringale, MD
      • Brockton, Massachusetts, United States, 02301
        • Recruiting
        • Brockton Neighborhood Health Center
        • Contact:
          • Madhur Kuckreja, MD
      • East Boston, Massachusetts, United States, 02128
        • Recruiting
        • East Boston Neighborhood Health Center
        • Contact:
          • Heidi Emerson, PhD
      • Hyannis, Massachusetts, United States, 02601
        • Recruiting
        • Duffy Health Center
        • Contact:
          • Lisa Jones, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Staff members at partnering sites (see locations) who are administrative leaders, population health managers, data analysts, quality improvement staff, nurses, nurse managers, practice managers, medical assistants, and providers.
  • Staff members at partnering sites ages 18+.

Exclusion Criteria:

  • Staff members that are not involved in CRC screening practices at CHCs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Introduction of Implementation Strategies
The investigators will determine the best intervention and strategy (and thus implementers) based on high ranking barriers/facilitators identified in focus groups. A minimum of 2 implementation strategies will be developed and implemented at each level (patient, provider, system) at each site that considers (1) implementation strategy; (2) mechanism in which the strategy impacts the identified determinant (3) the determinant; (4) moderators that may influence the impact of the strategy; (5) the preconditions necessary for successful implementation; and (6) implementation outcomes affected. Each community health center (CHC) will serve as its own separate subject, and individual strategies will be tested using single case experimental design (SCED) at each CHC using component analysis to rapidly test and optimize our strategies. In SCED each subject serves as their own control, an intervention is systematically introduced and withdrawn, and the effects of the intervention are measured.
Behavioral: Implementation Science Strategy
The investigators will be conducting focus groups and identifying barriers and facilitators, and the investigators will be matching identified barriers and facilitators to implementation strategies at the patient, provider, and system level which the investigators will be testing using rapid-cycle methods.
No Intervention: Withdrawal of Implementation Strategies
In SCED each subject serves as their own control, an intervention is systematically introduced and withdrawn, and the effects of the intervention are measured.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Outcome 1: Acceptability of Implementation Strategies
Time Frame: 4 months
The investigators will measure the acceptability of the implementation strategies determined in Aim 2. This will be measured through a post-implementation survey given to the CHC staff members who participate in systems-level implementation at the two CHC pilot test sites in Aim 3.
4 months
Primary Outcome 2: Feasibility of Implementation Strategies
Time Frame: 4 months
The investigators will measure the feasibility of the implementation strategies determined in Aim 2. This will be measured through a post-implementation survey given to the CHC staff members who participate in systems-level implementation at the two CHC pilot test sites in Aim 3.
4 months
Primary Outcome 3: Appropriateness of Implementation Strategies
Time Frame: 4 months
The investigators will measure the appropriateness of the implementation strategies determined in Aim 2. This will be measured through a post-implementation survey given to the CHC staff members who participate in systems-level implementation at the two CHC pilot test sites in Aim 3.
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Outcome: CRC Screening Rates
Time Frame: 4 months
The secondary outcomes will be change in colorectal cancer screening rate. This will be measured by the difference in the colorectal cancer screening tests ordered and completed compared to the pre-implementation period.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Adjoa Anyane-Yeboa, MD, MPH, Mass General Hospital // Harvard Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

August 24, 2022

First Submitted That Met QC Criteria

August 31, 2022

First Posted (Actual)

September 1, 2022

Study Record Updates

Last Update Posted (Estimated)

November 14, 2025

Last Update Submitted That Met QC Criteria

November 12, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22167
  • P50CA244433 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD will be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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