Clinical trial · Interventional
The PharmFIT Study
Expanding Access to Colorectal Cancer Screening Through Community Pharmacies: The PharmFIT Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PharmFIT | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention: PharmFIT
- description
- 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.
- interventionNames
- Behavioral: PharmFIT
- type
- NO_INTERVENTION
- label
- Control: Usual Care
- description
- Subjects randomized to this arm receive usual care.
Primary outcomes (6)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: Clinic and pharmacy staff (n up to 100) * Age ≥18 years * Employed at a participating primary care clinic or pharmacy * Fluent in English * Has access to a computer with internet Exclusion Criteria: Clinic and pharmacy staff * Floaters/per diem employees * Those who would object to having their interview audio recorded * Those who would object to participation in evaluation surveys Inclusion Criteria: Patients (n=1400) * Age 45-75 years * Patient at a participating primary care facility (medical visit within last 18 months) * Current resident of NC or WA state * Not up to date with recommended screening (e.g., no colonoscopy within 10 years, no FIT-DNA test within 3 years; no FIT/FOBT within 12 months) * English and Spanish speakers * Has access to a computer or smartphone with internet Exclusion Criteria: Patients * Previous USPST CRC screening within recommended screening period: 1) Colonoscopy within the past 10 years, 2) FIT/FOBT/FIT-DNA test within the past 12 months, 3) Previous sigmoidoscopy within the past 5 years, 4) Previous CT colonography within the past 10 years, 5) Other CRC screening tests * CRC screening is contraindicated * Previous positive FIT/FOBT/FIT-DNA * Colorectal neoplasm or colorectal polyp * Adenoma by biopsy * Family history of colorectal cancer * Diagnosed with inflammatory bowel disease * Total or partial colectomy * Diagnosis of Alzheimer's/other forms of severe dementia * Resides in an assisted living facility * Currently receiving hospice care * Diagnosed with end stage renal disease * Current diagnosis of certain cancers (e.g., CRC, mesothelioma, glioblastoma, lung, pancreatic, and liver/bile duct)
References
Publications (1)
- DERIVEDGlascock M, Wangen M, Ferrari RM, O'Leary MC, Schwartz J, Ndugulile M, Unger JM, Li L, Marciniak MW, Reuland DS, Watabayashi K, Brenner AT, Wheeler SB, Shah PD. Expanding access to colorectal cancer screening through community pharmacies: Study protocol for the PharmFIT randomized controlled trial. Contemp Clin Trials. 2026 Aug 22:108443. doi: 10.1016/j.cct.2026.108443. Online ahead of print. PMID 42632449