PharmFIT for Colorectal Cancer Screening

(PharmFIT Trial)

Not yet recruiting at 1 trial location
AT
PD
Overseen ByParth D Shah, PharmD PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: UNC Lineberger Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to increase colorectal cancer screening by using pharmacies to distribute and support the use of a simple test called FIT (Fecal Immunochemical Test). The goal is to determine if this approach helps more people complete their screenings compared to those receiving usual care. Individuals who haven't had their recommended screenings for colorectal cancer, live in North Carolina or Washington state, and have internet access might be suitable for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance cancer screening accessibility and effectiveness.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the PharmFIT intervention is safe for colorectal cancer screening?

Research shows that the PharmFIT program is easy for patients to use. Previous studies have found that people feel comfortable using pharmacies for colorectal cancer screening. The PharmFIT program involves picking up a stool test kit from a pharmacy, providing a simple and non-invasive way to check for signs of cancer.

Importantly, no serious side effects have been reported from using the FIT (fecal immunochemical test), the main tool in this program. The goal is to make screening more accessible, with assistance from pharmacists.

The trial is labeled "Not Applicable" for phases, indicating that no new drugs or procedures are being tested for safety. Instead, it focuses on improving access to an existing screening method. Given this context, the PharmFIT approach is expected to be safe for participants.12345

Why are researchers excited about this trial?

Researchers are excited about PharmFIT for colorectal cancer screening because it integrates pharmacists into the process, offering personalized support that standard care often lacks. While typical screening methods involve patients navigating the process largely on their own, PharmFIT facilitates pharmacist-led support to address barriers like fear, transportation, and financial issues. This means patients receive help scheduling colonoscopies, understanding procedure prep, and discussing results, potentially increasing screening rates and early detection.

What evidence suggests that the PharmFIT intervention is effective for increasing colorectal cancer screening rates?

Research shows that PharmFIT, the intervention being tested in this trial, could greatly enhance colorectal cancer screening. Studies have found that using the FIT (Fecal Immunochemical Test) in pharmacies can help detect cancer early, especially in communities with limited healthcare access. Early results suggest that participants find PharmFIT more convenient and preferable compared to other screening methods. This approach not only simplifies the screening process but also supports better follow-up care. By making tests available at local pharmacies, more individuals might complete their screenings, potentially catching cancer early when treatment is more effective.23467

Who Is on the Research Team?

AT

Alison T Brenner, PhD MPH

Principal Investigator

University of North Carolina, Chapel Hill

PD

Parth D Shah, PharmD PhD

Principal Investigator

Fred Hutchinson Cancer Center

Are You a Good Fit for This Trial?

The PharmFIT Study is for primary care patients who are behind on their colorectal cancer (CRC) screenings. It's also for clinic and pharmacy staff employed at participating clinics or pharmacies, fluent in English, and with computer access.

Inclusion Criteria

Inclusion Criteria: Clinic and pharmacy staff (n up to 100)
* Fluent in English
* Employed at a participating primary care clinic or pharmacy
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the PharmFIT intervention, including referral to pharmacies for CRC screening via FITs, counseling, and support for screening completion.

6 months
Multiple interactions with pharmacy staff and primary care providers

Follow-up

Participants are monitored for completion of CRC screening and follow-up colonoscopy if needed.

6 months

Cost Analysis

Assessment of the incremental cost of the PharmFIT intervention compared to usual care.

Up to 12 months

What Are the Treatments Tested in This Trial?

Interventions

  • PharmFIT

Trial Overview

This study tests a pharmacy-based intervention called PharmFIT to see if it increases CRC screening rates. Patients will be randomly placed into two groups: one receiving usual care and the other getting the PharmFIT program.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Intervention: PharmFITExperimental Treatment1 Intervention
Group II: Control: Usual CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials
377
Recruited
95,900+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Fred Hutchinson Cancer Center

Collaborator

Trials
583
Recruited
1,341,000+

Citations

Patient willingness to use a pharmacy-based colorectal ...

Respondents who completed a recent CRC screening appraised higher relative advantage of PharmFIT™ over other ways to get screened compared to ...

Study Details | NCT06656936 | The PharmFIT Study

The long-term goal of this study is to reduce CRC mortality by increasing access to CRC screening. The overall objective is to evaluate the effectiveness and ...

Pharmacy-Based FIT Screening Could Boost Colorectal ...

Pharmacy-based CRC screening programs using FIT can improve early detection, especially in underserved communities, with effective follow-up ...

HPDP researchers receive a $3 million grant to study ...

This study will then assess whether PharmFIT™ is effective in not only distributing preventative cancer screening but also increasing use of ...

The PharmFIT Study | MedPath

The long-term goal of this study is to reduce CRC mortality by increasing access to CRC screening. The overall objective is to evaluate the effectiveness and ...

Colorectal cancer screening knowledge among community ...

We assessed community pharmacists' knowledge about CRC screening to identify education and training needs for a pharmacy-based CRC screening program.

It's a good idea, but are they willing? Assessing pharmacist ...

We assessed willingness to provide a pharmacy-based CRC screening program (PharmFIT™). We used multiple linear regression to identify correlates ...