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The PharmFIT Study

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 99 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

The PharmFIT Study tests whether offering FIT stool tests through pharmacies helps more people get screened for colon and rectal cancer. Patients ages 45–75 who are behind on screening will be assigned by chance to usual care or PharmFIT. Clinic and pharmacy staff can also take part in interviews and surveys.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Patients: Ages 45–75.
  • Patients: Had a medical visit at a participating primary care clinic within the past 18 months.
  • Patients: Live in North Carolina or Washington state.
  • Patients: Are behind on cancer screening. Examples include no colonoscopy in 10 years, no FIT-DNA stool test in 3 years, or no FIT/FOBT stool test in 12 months.
  • Patients: Speak English or Spanish.
  • Patients: Have a computer or smartphone with internet access.
  • Staff: Age 18 or older and work at a participating primary care clinic or pharmacy.
  • Staff: Speak English fluently and have a computer with internet access.

Who can't join

  • Staff: Work as floating or day-by-day staff, or do not agree to audio-recorded interviews or evaluation surveys.
  • Patients: Have had recent screening, including a colonoscopy in 10 years; FIT, FOBT, or FIT-DNA stool test in 12 months; sigmoidoscopy (a lower-colon scope exam) in 5 years; or CT colonography (a colon scan) in 10 years. Other screening tests may also rule you out.
  • Patients: Cannot safely have screening, or have had a positive FIT, FOBT, or FIT-DNA stool test.
  • Patients: Have a colon or rectal tumor or polyp, or an adenoma (a growth found by testing a tissue sample).
  • Patients: Have a family history of colon or rectal cancer, inflammatory bowel disease (long-term bowel swelling), or surgery to remove all or part of the colon.
  • Patients: Have Alzheimer's disease or another form of severe dementia, live in assisted living, or receive hospice care.
  • Patients: Have end-stage kidney disease, when the kidneys no longer work well enough.
  • Patients: Currently have certain cancers, such as colon or rectal, lung, pancreatic, liver or bile duct cancer; mesothelioma (cancer of organ linings); or glioblastoma (a brain cancer).

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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)

Study sites (2)

NC

WA