Patient Navigation for Cervical Cancer Prevention

(PINPOINT Trial)

Not yet recruiting at 1 trial location
RM
DR
Overseen ByDaniela Rivero-Mendoza, MS.
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University of Florida
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a support program called PINPOINT, designed to help individuals at high risk for cervical cancer receive necessary screenings. The program assigns a patient navigator to provide reminders, education, and an opportunity for participants to collect their own sample for screening. The trial seeks women who have not been screened for cervical cancer in over three years, have obesity or Type 2 Diabetes, and reside in specific counties. Participants must also have access to a mobile phone or email. The goal is to determine if this additional support increases screening rates. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance cervical cancer screening support for many.

What prior data suggests that the PINPOINT intervention is safe for cervical cancer prevention?

Research has shown that programs like the PINPOINT intervention are safe and well-received. These programs significantly increase cervical cancer screening rates without major safety issues. For instance, one study found that patient navigation increased screening rates by up to 15.6% in a year, demonstrating the program's effectiveness and safety.

No reports of negative effects from the PINPOINT intervention itself exist. The program includes sending reminders and providing educational support to help patients complete their cervical cancer screenings. Participants generally find this support helpful and not bothersome.

Overall, evidence suggests that the PINPOINT intervention safely boosts cervical cancer screening rates, with no reported negative effects on participants.12345

Why are researchers excited about this trial?

Researchers are excited about the PINPOINT intervention for cervical cancer prevention because it introduces patient navigation as a novel element. Unlike standard procedures that only send reminders, this approach provides personalized assistance, helping patients overcome barriers to screening and educating them about cervical cancer. Additionally, it offers the innovative option for patients to self-collect their screening samples, making the process more accessible and less invasive. This could lead to higher screening rates and earlier detection, which is a significant step forward in cancer prevention.

What evidence suggests that the PINPOINT intervention is effective for cervical cancer prevention?

Research has shown that the PINPOINT program, which participants in this trial may receive, can increase cervical cancer screening rates among women. Studies have found that reminders and support to overcome obstacles boost participation in screening programs. This approach is especially beneficial for high-risk women who don't follow standard screening guidelines. The PINPOINT program also provides a self-sampling option for cervical cancer screening, making the process easier and more comfortable. Early evidence suggests these methods are practical and well-received by patients, potentially leading to better prevention outcomes.16789

Are You a Good Fit for This Trial?

This trial is for women over 25 living in specific Florida counties who haven't had a cervical cancer screening in the last 3 years, are not pregnant, and have no history of cervical cancer or hysterectomy. They must be overweight or have Type 2 diabetes, been to UF Internal Medicine recently, and can receive messages on a mobile phone or via email.

Inclusion Criteria

I am over 25 years old, following ACS screening guidelines.
Have not undergone cancer screening in the past 3 years or more
I have not had a hysterectomy.
See 9 more

Exclusion Criteria

I have had cervical cancer in the past.
I have had my uterus removed.
Pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants are randomized to receive either the PINPOINT intervention or standard care. The intervention includes patient navigation, education on cervical cancer screening, and the option for self-collection of samples.

6 months

Follow-up

Participants are monitored for the acceptability, appropriateness, and feasibility of the intervention, as well as completion of cervical cancer screening.

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • PINPOINT Intervention

Trial Overview

The PINPOINT intervention is being tested to see if it helps high-risk patients get screened for cervical cancer. It involves patient navigation support and self-collection methods instead of traditional clinician-administered Pap smears.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention
Group II: Control ArmActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials
1,428
Recruited
987,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Citations

Improving Cervical Cancer Prevention Among Women ...

27 Outcome: The PINPOINT intervention will have positive outcomes in terms of feasibility and acceptability among patients. Official Title.

Cervical Cancer Screening Cascade: A Framework for ...

It was developed to support global health programs in collecting accurate and timely data for better decision-making in cervical cancer ...

Understanding Cervical Cancer Screening Attendance

The purpose of this study is to investigate the factors limiting Romanian women's participation in cervical cancer screening.

A cross-sectional analysis of factors associated with cervical ...

Despite screening efficacy, the American Cancer Society estimates 13,360 new diagnoses and 4,320 deaths from cervical cancer in the US in 2025 [ ...

Excess Cervical Cancer Mortality: A Marker for Low Access ...

Women living in areas characterized by excess cervical cancer mortality also experience mortality rates above the national average for breast cancer, colon ...

Patient Navigation Improves Rates of Cancer Screening ...

For cervical cancer, the predicted 1-year absolute screening rate was estimated to be 15.6% higher with patient navigation, although this rate ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40489104/

Patient Navigation Services for Breast and Cervical Cancer ...

Predicted 1-year absolute rates following patient navigation were 13.8% higher for breast cancer screening and 15.6% higher for cervical cancer ...

Cervical Cancer Screening: Patient Navigation

Patient navigation interventions increased cervical cancer screening by a median of 22.5 percentage points or 64.5%. Summary of Economic Evidence. The ...

Impact of Patient Navigation Interventions on Timely ...

These results suggest that patient navigation can improve timely diagnostic follow-up among women with low-risk cervical abnormalities.