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NCT Number: NCT06656936

The PharmFIT Study

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, United States

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About this 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 implementation of a pharmacy-based FIT (PharmFIT) intervention. PharmFIT is a collaborative patient care service intervention that involves primary care clinics identifying active patients who are due for screening and referring them, outside of a medical visit, to community pharmacies to receive their CRC screening via FITs. The program consists of 1) Patient eligibility assessments and endorsement by the Primary Care Provider (PCP); 2) Counseling on FIT use and return by the pharmacists; 3) Reminders to complete screening by the pharmacy staff; 3) Test result communication by the pharmacists/PCPs; and 4) Patient navigation and care coordination for follow-up care by both pharmacists and PCPs.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Service Penetration (Effectiveness)

    Time frame: 6-months post randomization

    Receipt of any USPSTF guideline recommended CRC screening (FIT, FIT-DNA, sigmoidoscopy, colonoscopy, CT colonography, or barium enema), using a yes ["1"] vs. no ["0"] dichotomous outcome in the 6 months following randomization.

  2. Appropriateness of the PharmFIT intervention

    Time frame: 6-months post enrollment

    Perceptions that PharmFIT is agreeable, palatable, or satisfactory.

  3. Acceptability of the PharmFIT intervention

    Time frame: 6-months post enrollment

    Perceptions that PharmFIT is relevant to, fits or is compatible with a given practice site, provider, or patient.

  4. Feasibility of the PharmFIT intervention

    Time frame: 6-months post enrollment

    Extent to which PharmFIT was successfully implemented and used within the clinics and pharmacies, measured by the Implementation Outcomes Questionnaire (IOQ) Feasibility Subscale.

  5. Fidelity to the PharmFIT intervention

    Time frame: Baseline, 6-months post enrollment

    PharmFIT delivered as intended; adherence; integrity; quality of PharmFIT intervention delivery, measured using the study's REDCap tracking database (e.g., patient communications delivered, FIT kits distributed, results reports, etc.).

  6. Cost of the PharmFIT intervention

    Time frame: Through study completion, up to 12 months after PharmFIT intervention implementation

    Incremental cost of each additional patient screened in the intervention arm compared to usual care. Comparison of the programmatic costs incurred, and number of subjects screened in Arm 1(trial PharmFIT) compared to Arm 2 (usual care), measured as cost of intervention minus the cost of usual care, divided by the number screened in Arm 1 minus the number screened in Arm 2.

    Intervention costs will be assessed using periodic episodes of direct observation of PharmFIT outreach activities, time logs maintained by the intervention team, and assembly of administrative data capturing non-personnel/non-labor expenditures, such as costs associated with materials printing, FIT processing, and mailing costs. Usual care costs will be estimated using data collected from collaborative process flow diagramming sessions.

Secondary outcomes

  1. Reach

    Time frame: 6-months post enrollment

    A) The total number of patients who received referrals after being identified for screening, overall and by patient sex, race, ethnicity, age group, insurance category, rurality, previous screening behavior, and clinic/pharmacy cluster. B) The number of patients who received referrals after being identified for screening, overall and by patient sex, race, ethnicity, age group, insurance category, rurality, previous screening behavior, and clinic/pharmacy cluster.

  2. Timely FIT completion

    Time frame: 60 days post FIT receipt

    Proportion of patients randomized to PharmFIT who completed the FIT within 60 days.

  3. Timely follow-up colonoscopy

    Time frame: 6-months post enrollment

    Proportion of patients with positive FIT results completing follow-up colonoscopy within 6 months following positive FIT results.

Study contacts

Contact information is provided by the study sponsor or research team.

Alison T Brenner, PhD MPH

CONTACT

[email protected]

919-914-0979

Parth D Shah, PharmD PhD

CONTACT

[email protected]

206-667-6120

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • Fred Hutchinson Cancer Center
  • National Cancer Institute (NCI)

Registry information

Official study title

Expanding Access to Colorectal Cancer Screening Through Community Pharmacies: The PharmFIT Study

Acronym: PharmFIT

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
Oct 24, 2024
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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