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

NCT05524428 | Recruiting DMC

• 2 other identifiers: 22167P50CA244433
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Colo-rectal Cancer

Keywords

colorectal cancer; cancer; screening; implementation science; health equity; cancer equity; healthcare access; minority health; early detection; public health; health justice; rapid testing

Outcome Measures

Primary Outcomes (3)

• 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.

  4 months

• 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.

  4 months

• 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.

  4 months

Secondary Outcomes (1)

• Secondary Outcome: CRC Screening Rates

  4 months

Study Arms (2)

Introduction of Implementation Strategies

OTHER

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

Withdrawal of Implementation Strategies

NO INTERVENTION

In SCED each subject serves as their own control, an intervention is systematically introduced and withdrawn, and the effects of the intervention are measured.

Interventions

Implementation Science Strategy BEHAVIORAL

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.

Introduction of Implementation Strategies

Eligibility Criteria

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

You may qualify if:

• 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+.

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

Codman Square Health Center

Boston, Massachusetts, 02124, United States

RECRUITING

Brockton Neighborhood Health Center

Brockton, Massachusetts, 02301, United States

RECRUITING

East Boston Neighborhood Health Center

East Boston, Massachusetts, 02128, United States

RECRUITING

Duffy Health Center

Hyannis, Massachusetts, 02601, United States

RECRUITING

Related Publications (13)

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

  BACKGROUND

• 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.

  PMID: 32133645 BACKGROUND

• 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.

  PMID: 28376186 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 24393412 BACKGROUND

• 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.

  PMID: 29846947 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 26844165 BACKGROUND

• 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.

  PMID: 18304342 BACKGROUND

• 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.

  PMID: 15207986 BACKGROUND

• 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.

  PMID: 16049812 BACKGROUND

• 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.

  PMID: 25264468 BACKGROUND

• 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.

  PMID: 21541152 BACKGROUND

MeSH Terms

Conditions

Colonic Neoplasms; Colorectal Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Adjoa Anyane-Yeboa, MD, MPH

  Mass General Hospital // Harvard Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adjoa Anyane-Yeboa, MD, MPH

CONTACT

617-726-2426; aanyane-yeboa@mgh.harvard.edu

Nathan Yoguez, MPH

CONTACT

nyoguez@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastroenterologist // Instructor of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: September 1, 2022
• Study Start: March 24, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)