The PharmFIT Study

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT06656936
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Accepted

Interventions

  • PharmFIT — BEHAVIORAL
    The PharmFIT intervention involves the following components: referral notice to patient, FIT ready notification, FIT ready reminders, FIT distribution, FIT completion reminders, negative and positive results notification, patient navigation support.

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
Dec 2025
Primary completion
Dec 31, 2027
Completion
Jan 31, 2029

Study Design

Enrollment
1,500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Intervention: PharmFIT
    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.
  • No Intervention: Control: Usual Care
    Subjects randomized to this arm receive usual care.

Primary Outcome Measure

Service Penetration (Effectiveness) [ Time Frame: 6-months post randomization ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel HillNorth Carolina27599
Alison Brenner
[email protected]
919-843-3392
Alison Brenner, PhD (PRINCIPAL_INVESTIGATOR)
Fred Hutch Cancer CenterSeattleWashington98109
Parth Shah
[email protected]
206-667-1111
Parth Shah, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chapel Hill, NC

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill· Chapel Hill, NCFred Hutch Cancer Center· Seattle, WA

Related Studies