PharmFIT for Colorectal Cancer Screening

(PharmFIT Trial)

Not yet recruiting at 1 trial location

Overseen By Parth D Shah, PharmD PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: UNC Lineberger Comprehensive Cancer Center

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will conduct a randomized controlled trial to assess the impact of a pharmacy-based FIT intervention, Pharmacy-based FIT (PharmFIT), on colorectal cancer screening (CRC) screening rates in primary care patients who are not up to date on CRC screening. Through collaboration with community partners in North Carolina and the Pacific Northwest region, 1) the impact will be evaluated, 2) the implementation will be assessed, and 3) the costs of the PharmFIT intervention cost will be estimated. Patients (n=1,200) will be individually randomized to a usual care arm or a PharmFIT arm and we will determine whether there are statistically significant differences in CRC screening rates. Concurrently, a mixed methods approach will be used to assess a range of preliminary implementation outcomes, identify outcome barriers and facilitators, and identify implementation strategies to support future research. Also, the cost of PharmFIT will be calculated, using collaborative process flow diagramming (PFD) to inform micro-costing and budget impact analysis. Supported by preliminary work from the investigators, demonstrating widespread acceptability, feasibility, and preliminary effectiveness of PharmFIT, the rationale to conduct this hybrid 1 effectiveness-implementation trial1 is to generate new knowledge about pharmacy-based interventions to effectively increase CRC screening uptake and implementation. The central hypothesis is that the PharmFIT intervention will increase screening uptake by improving access to, and opportunities for, this preventive service through the involvement of a multidisciplinary, multisite, team-based care approach to CRC screening.

Who Is on the Research Team?

Alison T Brenner, PhD MPH

Principal Investigator

University of North Carolina, Chapel Hill

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

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?

Group I: Intervention: PharmFIT Experimental Treatment 1 Intervention

Subjects enrolled in the PharmFIT intervention will receive a referral notice from their primary care facility to pick up a FIT and receive support for screening from their pharmacist. After receiving the FIT and completing the FIT subject will receive their FIT results. Those with positive results will also be provided patient navigation support. This support will be provided by the pharmacist, in collaboration with the subject's PCP, and will include a) Discussing barriers to colonoscopy (e.g., fear, lack of transportation, inability to pay); b) Support for and confirmation of colonoscopy appointment scheduling; c) Review and support prep procedures; e) Post-procedure, discuss results and answer questions.

Group II: Control: Usual Care Active Control 1 Intervention

Subjects randomized to this arm receive usual care.

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+