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Colo-rectal CancerNCT05524428

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

A study testing Implementation Science Strategy in people with Colo-rectal Cancer, run by Massachusetts General Hospital at 4 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Colo-rectal Cancer
What is being tested?
Implementation Science Strategy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
4 sitesUnited States
Study dates
24 Mar 2023to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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+.

Who cannot join

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

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Adjoa Anyane-Yeboa, MD, MPH contact

617-726-2426

aanyane-yeboa@mgh.harvard.edu

Nathan Yoguez, MPH contact

nyoguez@mgh.harvard.edu

United States4 sites, 4 recruiting
  • Codman Square Health Center

    Boston, Massachusetts, 02124

    Stephen Tringale, MD

    Recruiting
  • Brockton Neighborhood Health Center

    Brockton, Massachusetts, 02301

    Madhur Kuckreja, MD

    Recruiting
  • East Boston Neighborhood Health Center

    East Boston, Massachusetts, 02128

    Heidi Emerson, PhD

    Recruiting
  • Duffy Health Center

    Hyannis, Massachusetts, 02601

    Lisa Jones, MD

    Recruiting

Other trials in United States

About this study

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.

Read the 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.
Being tested
Implementation Science Strategy
Keywords
colorectal cancer, cancer, screening, implementation science, health equity, cancer equity, healthcare access, minority health, early detection, public health, health justice, rapid testing
Medical subject headings
Colonic Neoplasms, Colorectal Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Implementation Science StrategyBehavioural

    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.

Study groups in NCT05524428
Study groupRoleWhat they receive
Introduction of Implementation StrategiesOtherThe 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.
Receives: Behavioral: Implementation Science Strategy
Withdrawal of Implementation StrategiesNo interventionIn 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Outcome 1: Acceptability of Implementation Strategies

    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.

    Measured: 4 months

  2. Primary Outcome 2: Feasibility of Implementation Strategies

    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.

    Measured: 4 months

  3. Primary Outcome 3: Appropriateness of Implementation Strategies

    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.

    Measured: 4 months

Secondary outcomes (1)
  1. Secondary Outcome: CRC Screening Rates

    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.

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2022
  2. Study start24 Mar 2023
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Non-randomised
Intervention model
Sequential
Model description
The investigators will use a mixed methods approach involving qualitative focus groups with health center providers and staff to identify barriers and facilitators to screening, and implementation science methods to test multilevel implementation strategies at the health centers.
Masking
None (open label)
Enrolment
2 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05524428
Sponsor's protocol ID
22167
Other IDs
P50CA244433
Status last verified
Nov 2025
First submitted
24 Aug 2022
Last updated
14 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No IPD will be shared with other researchers.

Publications

  • Roundtable NCC. Data & Progress. National Colorectal Cancer Roundtable; 2020.

  • Siegel RL, Miller KD, Goding Sauer A, Fedewa SA, Butterly LF, Anderson JC, Cercek A, Smith RA, Jemal A. Colorectal cancer statistics, 2020. CA Cancer J Clin. 2020 May;70(3):145-164. doi: 10.3322/caac.21601. Epub 2020 Mar 5.

    PubMed 32133645
  • Siegel RL, Fedewa SA, Anderson WF, Miller KD, Ma J, Rosenberg PS, Jemal A. Colorectal Cancer Incidence Patterns in the United States, 1974-2013. J Natl Cancer Inst. 2017 Aug 1;109(8):djw322. doi: 10.1093/jnci/djw322.

    PubMed 28376186
  • Roundtable NC. American Cancer Society. Accessed November 5, 2020, https://nccrt.org/what-we-do/80-percentby-2018/

  • Ahnen DJ, Wade SW, Jones WF, Sifri R, Mendoza Silveiras J, Greenamyer J, Guiffre S, Axilbund J, Spiegel A, You YN. The increasing incidence of young-onset colorectal cancer: a call to action. Mayo Clin Proc. 2014 Feb;89(2):216-24. doi: 10.1016/j.mayocp.2013.09.006. Epub 2014 Jan 4.

    PubMed 24393412
  • Wolf AMD, Fontham ETH, Church TR, Flowers CR, Guerra CE, LaMonte SJ, Etzioni R, McKenna MT, Oeffinger KC, Shih YT, Walter LC, Andrews KS, Brawley OW, Brooks D, Fedewa SA, Manassaram-Baptiste D, Siegel RL, Wender RC, Smith RA. Colorectal cancer screening for average-risk adults: 2018 guideline update from the American Cancer Society. CA Cancer J Clin. 2018 Jul;68(4):250-281. doi: 10.3322/caac.21457. Epub 2018 May 30.

    PubMed 29846947
  • Force USPST. Draft Recommendation Statement: Colorectal Cancer Screening. U.S. Preventive Services Task Force; 2020.

  • Brown T, Lee JY, Park J, Nelson CA, McBurnie MA, Liss DT, Kaleba EO, Henley E, Harigopal P, Grant L, Crawford P, Carroll JE, Alperovitz-Bichell K, Baker DW. Colorectal cancer screening at community health centers: A survey of clinicians' attitudes, practices, and perceived barriers. Prev Med Rep. 2015 Sep 21;2:886-91. doi: 10.1016/j.pmedr.2015.09.003. eCollection 2015.

    PubMed 26844165
  • Lasser KE, Ayanian JZ, Fletcher RH, Good MJ. Barriers to colorectal cancer screening in community health centers: a qualitative study. BMC Fam Pract. 2008 Feb 27;9:15. doi: 10.1186/1471-2296-9-15.

    PubMed 18304342
  • O'Malley AS, Beaton E, Yabroff KR, Abramson R, Mandelblatt J. Patient and provider barriers to colorectal cancer screening in the primary care safety-net. Prev Med. 2004 Jul;39(1):56-63. doi: 10.1016/j.ypmed.2004.02.022.

    PubMed 15207986
  • Matthews BA, Anderson RC, Nattinger AB. Colorectal cancer screening behavior and health insurance status (United States). Cancer Causes Control. 2005 Aug;16(6):735-42. doi: 10.1007/s10552-005-1228-z.

    PubMed 16049812
  • Dallery J, Raiff BR. Optimizing behavioral health interventions with single-case designs: from development to dissemination. Transl Behav Med. 2014 Sep;4(3):290-303. doi: 10.1007/s13142-014-0258-z.

    PubMed 25264468
  • Ward-Horner J, Sturmey P. Component analyses using single-subject experimental designs: a review. J Appl Behav Anal. 2010 Winter;43(4):685-704. doi: 10.1901/jaba.2010.43-685.

    PubMed 21541152

Questions about this trial

What is this clinical trial studying?

A study testing Implementation Science Strategy in people with Colo-rectal Cancer, run by Massachusetts General Hospital at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Adjoa Anyane-Yeboa, MD, MPH (617-726-2426, aanyane-yeboa@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Outcome 1: Acceptability of Implementation Strategies (time frame: 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05524428, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025; AzTrials last refreshed its copy on 1 Nov 2026.

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