Screening Tool Implementation for Colorectal Cancer

((PB-iCRC) Trial)

Overseen By Joseph W LeMaster, MD MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Disqualifiers: Colorectal cancer history, Genetic risk, Cognitive incapacity

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

2200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to encourage more people to complete colorectal cancer (CRC) screenings by using a tool that helps plan when, where, and how to do the test. The tool, called NPT-PLA, is introduced in primary care clinics to determine if it increases the number of screenings compared to usual methods. Clinics are implementing this tool in two ways, one with additional training and support. This trial may suit patients due for CRC screening who receive regular primary care. As an unphased trial, it offers patients the chance to contribute to innovative strategies that could enhance CRC screening rates.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on colorectal cancer screening tools, so it's best to consult with the trial coordinators or your doctor for guidance.

What prior data suggests that this screening tool implementation is safe for colorectal cancer screening?

Research has shown that the NPT-PLA method is being tested to improve colorectal cancer screening in primary care. Specific safety data from clinical trials for NPT-PLA is not yet available. However, since this study involves using a screening tool rather than a new drug or invasive procedure, the focus is on integrating it into regular care. This typically results in fewer safety concerns compared to trials involving new medications or treatments. Participants will primarily experience changes in how they receive information and reminders about screenings, which are unlikely to cause harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to improve colorectal cancer (CRC) screening processes in clinics. Unlike the standard approach, which often follows a rigid protocol, the NPT-PLA method empowers clinic teams to customize the implementation of screening tools. By using Normalization Process Theory (NPT), this method encourages active participation and problem-solving, helping clinics identify and overcome barriers to effective screening. This tailored approach aims to enhance the adoption and completion of CRC screenings, potentially leading to earlier detection and better patient outcomes.

What evidence suggests that this trial's methods could be effective for improving colorectal cancer screening uptake?

Research has shown that tools like the I2 can increase colorectal cancer screening rates. For instance, one study found that sending an electronic reminder raised screening completion from 32.1% to 37.6%. Another study highlighted that educating people about screening significantly improves outcomes, as early detection offers a 90% survival rate when the cancer is localized. In this trial, the NPT-PLA approach tests the integration of these tools into clinic visits, encouraging collaboration between staff and patients to boost screening rates. This method includes training and support to tailor the tool to each clinic's needs, enhancing its effectiveness. Meanwhile, the Usual QI arm will implement a pre-set protocol without additional training or support. ^{6 7 8 9 10}

Who Is on the Research Team?

Christina Hester, PhD

Principal Investigator

DARTNet Institute

Joseph W LeMaster, MD MPH

Principal Investigator

University of Kansas

Keith A Greiner, MD MPH

Principal Investigator

University of Kansas

Are You a Good Fit for This Trial?

This trial is for patients eligible for colorectal cancer screening at clinics participating in the American Academy of Family Physicians National Research Network. It aims to include individuals with limited English proficiency and will enroll at least 100 patients per clinic.

Inclusion Criteria

I am a patient at the clinic, prefer Spanish, but can also speak English.

I am between 45 and 75 years old and due for a colon cancer screening but haven't had one recently.

Patients will be followed for 6 months after their initial invitation to complete I2

Exclusion Criteria

I have been found to have decision-making difficulties after a cognitive test.

I or my close family do not have a history of colorectal cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Active Intervention

Implementation of the I2 tool in clinics, with monthly meetings to plan and adapt workflows for CRC screening

6 months

Monthly meetings

Follow-up

Participants are monitored for CRC screening completion and tool usage

6 months

Summative Evaluation

Conduct qualitative focus group discussions to evaluate the implementation process

1 month

Focus group discussions

What Are the Treatments Tested in This Trial?

Interventions

• NPT-PLA
• Usual Quality Improvement

Trial Overview The study compares two methods of implementing a colorectal cancer screening tool: Normalization Process Theory-Participatory Learning in Action (NPT-PLA) versus usual quality improvement strategies across different clinics. The effectiveness, staff comprehension, workflow integration, and sustainability are evaluated.

How Is the Trial Designed?

Group I: NPT-PLA Experimental Treatment 1 Intervention

Clinics randomized to NPT-PLA will also define their CRC screening workflow via a checklist and preset I2 implementation protocol but will be trained initially then receive monthly support to facilitate a "Participatory Learning in Action" (PLA) session. NPT-PLA i-teams will identify barriers and supports to I2 implementation, and use Normalization Process Theory (NPT) constructs to guide identification, selection and ordering of action steps to progress implementation e.g. "(before taking the step) does everyone understand the step to be taken, does everyone who needs to act 'buy in', (during implementation of the step) is everyone who needs to act actually taking action to complete the step, (after the step is taken) did taking the step have the intended impact, if not what happened?" . NPT-PLA I-teams can adapt the I2 implementation protocol to fit their context, including when and how patients are presented with I2, to maximize I2 implementation and CRC screening completion.

Group II: Usual QI Active Control 1 Intervention

I-teams in each Usual QI clinic will be provided a pre-set protocol to implement the I2 tool into routine clinic CRC screening workflow (which they will define via a provided checklist). The protocol instructs the clinic to provide access to I2 zero to two weeks before a clinic visit, review the patient's I2 screening intentions with the patient in the clinic visit, at which time staff will order and schedule CRC screening in the visit. I2 may be completed on-line or via a paper form. I-teams will meet monthly to make progress on their implementation of I2, and complete a report/meet a study staff member monthly (separately) to report on their meetings and progress but will not receive coaching or skill training.

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

DARTNet Institute

Collaborator

Trials

5

Recruited

13,700+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A controlled trial involving 443 participants tested a combined intervention of a patient decision aid and practice-level support to increase colorectal cancer (CRC) screening rates, showing a modest increase in screening from 32.2% in usual care to 39% in the intervention group.

The intervention was particularly more effective for participants with higher incomes, suggesting that socioeconomic factors may influence the success of CRC screening interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a patient and practice-level colorectal cancer screening intervention in health plan members: the CHOICE trial. Pignone, M., Winquist, A., Schild, LA., et al.[2021]

In a study analyzing 130,831 colonoscopies, the overall bleeding rate was found to be 0.65%, with a very low rate of bleeding requiring transfusion (0.04%) and perforation (0.06%), indicating that the NHS bowel cancer screening program is relatively safe.

The study identified that larger polyp size and cecal location significantly increase the risk of adverse events, with cecal polypectomy showing a 13.5-fold increased risk of bleeding requiring transfusion and a 12.2-fold increased risk of perforation compared to distal colon procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors for adverse events related to polypectomy in the English Bowel Cancer Screening Programme. Rutter, MD., Nickerson, C., Rees, CJ., et al.[2022]

An electronic primer message sent through a patient portal significantly increased colorectal cancer (CRC) screening completion rates from 32.1% to 37.6% in a study of 2339 average-risk patients aged 50 to 75 years.

Patients who opened the electronic primer message had a 7.3% higher screening completion rate, and the time to complete screening was also shorter in the intervention group, indicating that digital reminders can effectively enhance participation in CRC screening programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Patient Portal Messaging Before Mailing Fecal Immunochemical Test Kit on Colorectal Cancer Screening Rates: A Randomized Clinical Trial. Goshgarian, G., Sorourdi, C., May, FP., et al.[2022]

The implementation of organized colorectal cancer (CRC) screening significantly increased screening participation from 38.9% in 2000 to 82.7% in 2015, demonstrating effective outreach in a community-based population.

This increase in screening was associated with a 25.5% reduction in CRC incidence and a 52.4% reduction in cancer mortality, highlighting the program's effectiveness in early detection and prevention of advanced-stage cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Organized Colorectal Cancer Screening on Cancer Incidence and Mortality in a Large Community-Based Population. Levin, TR., Corley, DA., Jensen, CD., et al.[2022]

In a study involving over 12,000 average-risk individuals undergoing colorectal cancer screening, total colonoscopy (TC) was associated with significantly higher levels of pain and serious reactions compared to flexible sigmoidoscopy (FS), indicating a greater discomfort for patients during TC procedures.

The bowel preparation for TC was poorly tolerated, leading to increased reports of severe pain and discomfort, which were predictive of post-procedural issues, highlighting the need for improved patient management strategies during this screening method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability and side-effects of colonoscopy and sigmoidoscopy in a screening setting. Senore, C., Ederle, A., Fantin, A., et al.[2022]

Offering a community laboratory drop-off (CLD) option for returning bowel screening test kits led to a 26% uptake among invitees, with significant increases in participation among males, individuals under 60, and Māori and Pacific populations.

The CLD option resulted in small but significant increases in screening participation at little or no additional cost, suggesting it could be beneficial for other bowel screening programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A community laboratory drop-off option for bowel screening test kits increases participation rates: results from an interrupted time series analysis. Sandiford, P., Buckley, A., Robinson, T., et al.[2021]

In a study involving 60,332 Vietnam-era veterans, various delivery methods for colorectal cancer screening (CRCS) interventions showed a combined increase in screening rates by 7% compared to controls, indicating that stepped interventions can be effective overall.

While individual interventions (like letters and phone calls) did not show statistically significant differences in CRCS rates, the cumulative effect of the interventions demonstrated a significant improvement in screening participation, highlighting the potential of multi-faceted approaches in increasing CRCS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A stepped randomized trial to promote colorectal cancer screening in a nationwide sample of U.S. Veterans. Vernon, SW., Del Junco, DJ., Coan, SP., et al.[2022]

The International Colorectal Cancer Screening Network evaluated 35 organized colorectal cancer screening programs across 24 countries, finding that most programs primarily used fecal occult blood tests, with significant variation in their ability to report screening measures.

Programs utilizing endoscopy for screening had much higher detection rates for polyps and neoplasia compared to those using fecal occult blood tests, highlighting the importance of screening method in identifying colorectal cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward standardizing and reporting colorectal cancer screening indicators on an international level: The International Colorectal Cancer Screening Network. Benson, VS., Atkin, WS., Green, J., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06682650

Implementation of a ColoRectal Cancer Screening Tool in ... NPT-PLA. Clinics randomized to NPT-PLA will also define their CRC screening workflow via a checklist and preset I2 implementation protocol but will be ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/16216030/

Results of a Randomized Controlled Trial to Increase ... Results: Thirty-two of the 36 POs were evaluable for outcome assessment. During the 2-year intervention period, only 26% of the eligible patients received any ...

3. withpower.com withpower.com/trial/phase-colorectal-neoplasms-10-2024-3c209

Screening Tool Implementation for Colorectal Cancer An electronic primer message sent through a patient portal significantly increased colorectal cancer (CRC) screening completion rates from 32.1% to 37.6% in a ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1555415521001215

Increasing Awareness of Screening Methods for Colorectal ... The 5-year survival rate with localized CRC is 90%, compared with metastasized at 14%. If health care providers do not adequately educate patients about ...

5. cghjournal.org cghjournal.org/article/S1542-3565(25)00525-7/fulltext

Cost-effectiveness of Novel Noninvasive Screening Tests ... At real-world adherence of 60%, mt-sRNA reduced CRC cases and deaths by 1% and 14% compared with FIT; by 21% and 19% compared with mt-sDNA; by ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10728768/

Incidence of Colorectal Cancer in Patients Diagnosed With ... In this patient-level matched retrospective cohort study, a significantly higher incidence of CRC was observed up to 3 years from PLA diagnosis.

7. the-hospitalist.org the-hospitalist.org/hospitalist/article/37994/critical-care/incidence-of-colorectal-cancer-in-patients-diagnosed-with-pla/

Incidence of Colorectal Cancer in Patients Diagnosed with ... Data from Southeast Asia suggests that patients with PLA have higher rates of asymptomatic CRC (seven-fold higher compared with patients without PLA).

8. nccrt.org nccrt.org/our-impact/data-and-progress/

Data and Progress - American Cancer Society ... We're tracking all major measures to assess our progress in reaching the goal of 80% of adults ages 45 or older screened for colorectal cancer.

9. cancer.gov cancer.gov/types/colorectal/hp/colorectal-screening-pdq

Colorectal Cancer Screening (PDQ®) - NCI The sensitivity for CRC was 93.9% (92/98) for the mt-sDNA test and 67.3% for FIT. According to the study, sensitivity did not vary substantially ...

10. clinicaltrials.gov clinicaltrials.gov/study/NCT05630794

NCT05630794 | Testing for Safety and Colorectal Cancer ... This phase I trial tests the safety, side effects, and best dose of ONC201 in preventing colorectal cancer in patients with familial adenomatous polyposis ...