Colorectal CancerPharmFITNCT06656936
The PharmFIT Study
A study testing PharmFIT in people with Colorectal Cancer, run by UNC Lineberger Comprehensive Cancer Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- PharmFIT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2026to 31 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Employed at a participating primary care clinic or pharmacy
- Fluent in English
- Has access to a computer with internet
- Age 45-75 years
- Patient at a participating primary care facility (medical visit within last 18 months)
Show all 10Show fewer
- 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
Who cannot join
- Floaters/per diem employees
- Those who would object to having their interview audio recorded
- Those who would object to participation in evaluation surveys
- 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
Show all 16Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599
Alison Brenner, alison.brenner@unc.edu
919-843-3392
Fred Hutch Cancer Center
Seattle, Washington, 98109
Parth Shah, 206-667-1111, pshah@fredhutch.org
Parth Shah, PhD
About this study
Official title: Expanding Access to Colorectal Cancer Screening Through Community Pharmacies: 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.
Read the detailed description
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.
- Conditions
- Colorectal Cancer
- Being tested
- PharmFIT
- Keywords
- Cancer Screening, Colorectal Cancer, Implementation Science, Rural Health, Minority Health, Community Pharmacies
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PharmFITBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: PharmFIT |
| Control: Usual Care | No intervention | Subjects randomized to this arm receive usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6-months post randomization
Appropriateness of the PharmFIT intervention
Perceptions that PharmFIT is agreeable, palatable, or satisfactory.
Measured: 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.
Measured: 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.
Measured: 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.).
Measured: 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.
Measured: Through study completion, up to 12 months after PharmFIT intervention implementation
Secondary outcomes (3)
Reach
- 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.
Measured: 6-months post enrollment
Timely FIT completion
Proportion of patients randomized to PharmFIT who completed the FIT within 60 days.
Measured: 60 days post FIT receipt
Timely follow-up colonoscopy
Proportion of patients with positive FIT results completing follow-up colonoscopy within 6 months following positive FIT results.
Measured: 6-months post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start1 Nov 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of two or more groups in parallel for the duration of the study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Fred Hutchinson Cancer Center
- Responsible party
- Sponsor
- Investigators
- Alison T Brenner, PhD MPH, Principal investigator, University of North Carolina, Chapel HillParth D Shah, PharmD PhD, Principal investigator, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06656936
- Sponsor's protocol ID
- LCCC2430
- Other IDs
- 1R01CA279010-01A1
- Acronym
- PharmFIT
- Status last verified
- Oct 2026
- First submitted
- 16 Sep 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All deidentified data generated through this trial, including survey instruments and interview guides, will be made publicly available on the UNC Dataverse (https://dataverse.unc.edu/).
Publications
Glascock 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.
PubMed 42632449
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding Access to Colorectal Cancer Screening Through Community Pharmacies: The PharmFIT Study
- ClinicalTrials.gov ID
- NCT06656936
- Acronym / sponsor ID
- PharmFIT / LCCC2430
- Conditions
- Colorectal Cancer
- Keywords
- Cancer Screening, Colorectal Cancer, Implementation Science, Rural Health, Minority Health, Community Pharmacies
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Fred Hutchinson Cancer Center
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 24 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two or more groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| Intervention: PharmFIT | Experimental | Behavioral: PharmFITSubjects 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. |
| Control: Usual Care | No intervention | –Subjects randomized to this arm receive usual care. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥18 years
- Employed at a participating primary care clinic or pharmacy
- Fluent in English
- Has access to a computer with internet
- Age 45-75 years
Key exclusion criteria (16 listed)
- Floaters/per diem employees
- Those who would object to having their interview audio recorded
- Those who would object to participation in evaluation surveys
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PharmFITThe 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. | Behavioural | Intervention: PharmFIT |
Primary outcome
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.
Appropriateness of the PharmFIT intervention
Time frame: 6-months post enrollment
Perceptions that PharmFIT is agreeable, palatable, or satisfactory.
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.
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.
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.).
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.
3 secondary outcomes
Reach
Time frame: 6-months post enrollment
Timely FIT completion
Time frame: 60 days post FIT receipt
Timely follow-up colonoscopy
Time frame: 6-months post enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Derived from this study: PubMed 42632449Glascock 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.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All deidentified data generated through this trial, including survey instruments and interview guides, will be made publicly available on the UNC Dataverse (https://dataverse.unc.edu/).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alison T Brenner, PhD MPH principal investigator
University of North Carolina, Chapel Hill
Parth D Shah, PharmD PhD principal investigator
Fred Hutchinson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PharmFIT in people with Colorectal Cancer, run by UNC Lineberger Comprehensive Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alison T Brenner, PhD MPH (919-914-0979, alison.brenner@unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Service Penetration (Effectiveness) (time frame: 6-months post randomization). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06656936, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.