The PharmFIT Study

NCT06656936 | Not Yet Recruiting

• 2 other identifiers: LCCC24301R01CA279010-01A1
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 2

Brief Summary

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

Colorectal Cancer

Keywords

Cancer Screening; Colorectal Cancer; Implementation Science; Rural Health; Minority Health; Community Pharmacies

Outcome Measures

Primary Outcomes (6)

• Service Penetration (Effectiveness)

  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.

  6-months post randomization

• Appropriateness of the PharmFIT intervention

  Perceptions that PharmFIT is agreeable, palatable, or satisfactory.

  6-months post enrollment

• Acceptability of the PharmFIT intervention

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

  6-months post enrollment

• Feasibility of the PharmFIT intervention

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

  6-months post enrollment

• Fidelity to the PharmFIT intervention

  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.).

  Baseline, 6-months post enrollment

• Cost of the PharmFIT intervention

  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.

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

Secondary Outcomes (3)

• Reach

  6-months post enrollment

• Timely FIT completion

  60 days post FIT receipt

• Timely follow-up colonoscopy

  6-months post enrollment

Study Arms (2)

Intervention: PharmFIT

EXPERIMENTAL

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.

Behavioral: PharmFIT

Control: Usual Care

NO INTERVENTION

Subjects randomized to this arm receive usual care.

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.

Intervention: PharmFIT

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Employed at a participating primary care clinic or pharmacy
• Fluent in English
• Has access to a computer with internet

You may not qualify if:

• Floaters/per diem employees
• Those who would object to having their interview audio recorded
• Those who would object to participation in evaluation surveys
• 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
• 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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• Fred Hutchinson Cancer Center: collaborator

Study Sites (2)

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

Chapel Hill, North Carolina, 27599, United States

Location

Fred Hutch Cancer Center

Seattle, Washington, 98109, United States

Location

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Alison T Brenner, PhD MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Parth D Shah, PharmD PhD

  Fred Hutchinson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alison T Brenner, PhD MPH

CONTACT

919-914-0979; alison.brenner@unc.edu

Parth D Shah, PharmD PhD

CONTACT

206-667-6120; pshah@fredhutch.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is a pragmatic trial, so study participants and the investigator team will be unblinded to study procedures, however, the outcomes assessors (biostatistical team) will be blinded to arm assignments.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are assigned to one of two or more groups in parallel for the duration of the study

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: October 24, 2024
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): January 31, 2029
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 months after trial results are published, or otherwise made available, with no end date.
• Access Criteria: Deidentified trial data shared on the UNC Dataverse will be made publicly available without access criteria. Additional data or information may be made available upon request.

Locations

US (2)