Improving Cervical Cancer Prevention Among Women Living With Chronic Conditions. (PINPOINT)

University of Florida

Status: Begins enrollment in 1 month

Conditions: Cervical Cancer (Early Detection); Diabetes; Obesity & Overweight

Treatments: Behavioral: patient navigation and self-collection

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07351110

IRB202500780

1K01CA292583-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Our overarching goal is to adapt and test the PINPOINT intervention -PatIent Navigation for the Prevention of CervIcal CaNcer inTervention. We will test the PINPOINT intervention among patients with high-risk profiles for cervical cancer who do not meet the recommended screening for cervical cancer.

Full description

We will test the PINPOINT intervention among patients with high-risk profiles for cervical cancer who do not meet the recommended screening for cervical cancer. We will use the six steps of the Intervention Mapping approach to guide the process of testing the intervention. This project aligns with the current efforts at the University of Florida Health Cancer Institute (UFHCI) and UF Health Internal Medicine to improve cervical cancer screening rates among under-screened women. We will partner with these efforts to test the PINPOINT intervention. Project CONTINUITY (Connecting You to Care in the Community) at UFHCI, Office of Community Outreach and Engagement (COE), is working to increase adherence to cervical screening and follow-up by; (1) providing personalized approaches to improve adherence through the combined use of patient choice for the initial screening method, community clinical navigators (CCN) and community health workers (CHWs), customized messages and support for patient portal access for test results, and (2) implementing strategies to address non-medical drivers that may influence an individual's ability to adhere to the screening, with an initial focus on removing transportation barriers through the use of a mobile outreach clinic (MOC).

Currently, a patient navigator supervised by Dr. Dianne Goede identifies patients who have an upcoming office visit and are due for cervical cancer screening at UF Health Internal Medicine. The patient navigator outreaches the patient, reminds them of their overdue status for cervical cancer screening and the importance of cervical cancer screening, and inquires if they are agreeable to complete screening at the scheduled office visit. We will reach out to patients who remain unscreened for cervical cancer 2 months after their scheduled visit with UF Health Internal Medicine. We will obtain a list of patients from the UF Health Consent2Share database. Patients who agree to participate in our study will be randomized to either receive the PINPOINT intervention (self-collection test with patient navigation) or standard of care (reminder to screen from UF Health Internal Medicine). We will use the sealed envelope randomization method to assign participants to either treatment or control groups right after intake.

We will pilot the PINPOINT intervention at UF Internal Medicine clinics and use Proctor's Framework for Implementation Outcomes to evaluate the intervention. Changes will be made to the intervention protocol and tested in a future randomized trial with a larger sample. Hypothesis: PINPOINT will meet the needs of women living with socioeconomic challenges, T2D, and obesity, and will align with the clinical workflow. PINPOINT will be appropriate, feasible and acceptable.27 Outcome: The PINPOINT intervention will have positive outcomes in terms of feasibility and acceptability among patients.

Enrollment: 20 estimated patients

Sex: Female

Ages: 25+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

The following eligibility criteria will be used to determine inclusion into the study:

1. Using the American Cancer Society (ACS) screening recommendations, adults aged over the age of 25 will be eligible
2. Active UF Internal Medicine patient and has had an appointment in the last 2 months.
3. Assigned sex at birth is female
4. Have Obesity or Type 2 Diabetes
5. Not currently pregnant (self-report)
6. Have not given birth in the prior 12 weeks
7. No previous history of cervical cancer
8. No previous history of a hysterectomy
9. Have not undergone cancer screening in the past 3 years or more
10. Reside in the UFHCI Catchment Area (Alachua, Baker, Bradford, Citrus, Clay, Columbia, Dixie, Gadsden, Gilchrist, Hamilton, Jefferson, Lafayette, Lake, Leon, Levy, Madison, Marion, Putnam, Sumter, Suwannee, Taylor, UnioF1n, or Wakulla County).
11. Have a mobile phone or access to a mobile phone that can be used to receive messages, or a valid email address.
12. Are not currently scheduled to receive cervical cancer screening via clinician sampling (pap smear).

Exclusion criteria

• Previous history of cervical cancer
• Total hysterectomy
• Pregnant

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Intervention

Experimental group

Description:

PINPOINT intervention arm will entail assigning patients to a patient navigator to assist them with screening reminders and address any barriers they have to screening, education on cervical cancer screening, and patients will also be offered the opportunity to self-collect their sample for cervical cancer screening.

Treatment:

Behavioral: patient navigation and self-collection

Control Arm

No Intervention group

Description:

No intervention arm, patients will receive reminders for screening according to current clinical practice