Development of Systems and Education for Cervical Cancer Prevention (DOSE-CC)

NCT07226037 | Not Yet Recruiting

• 2 other identifiers: H-46139R01CA299475
• Study Type: interventional
• Target: 80,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

Cervical cancer disproportionately impacts those who have not accessed screening or follow-up. Universal screening has the potential to decrease the overall burden of cervical cancer. However, more than half of the individuals who develop cervical cancer have not been screened in more than 5 years, and 20% did not follow-up after an abnormal result. To address this problem, the investigators will adapt and test an intervention to improve cervical screening and follow-up in three different settings: Northeastern US urban inner city (Boston), Southeastern US suburban (Florida), and remote west, rural (Hawaii). Our research group previously developed a successful intervention to improve primary cervical cancer prevention, which will be adapted for cervical cancer screening. The intervention combines education and quality improvement methods using a mechanism called Performance Improvement Continuing Medical Education. This type of intervention is attractive to clinicians because they are able to improve their cancer prevention practices while fulfilling requirements for maintaining board certification. When applied to primary prevention, the intervention improved rates by over 10 percentage points, and gains continued for over 4 years after the intervention concluded. The goal of the proposed research is to adapt the intervention to cervical cancer screening, and to evaluate its effectiveness in improving cervical cancer screening and follow-up after abnormal results. The proposed intervention represents an innovative and scalable model for promoting cancer prevention and screening activities by clinicians. Unlike programs that increase administrative burdens on busy clinicians, the proposed intervention allows clinicians to improve cancer prevention practices while simultaneously fulfilling requirements to maintain their board certification and improving the quality of cancer prevention care. It therefore has great potential for widespread dissemination.

Conditions

Cervical Cancer Screening; Cervical Cancer

Keywords

DOSE-CC; cervical cancer; prevention

Outcome Measures

Primary Outcomes (1)

• Number of participants who receive cervical cancer screening

  Defined as a cervical cytology (Pap test) and/or HPV test for those who are due

  1-5 years, depending on prior test and result

Secondary Outcomes (1)

• Number of participants with diagnostic resolution among those with abnormal screening results per 2019 ASCCP guidelines

  18 months

Study Arms (1)

DOSE-CC Intervention: Educational Sessions

EXPERIMENTAL

The primary goals of the DOSE-CC intervention are to 1) use education and training to increase clinician motivation to provide guideline-concordant screening and follow-up and reduce missed opportunities, and 2) support systems changes to improve screening and follow-up processes. Repeated contacts with clinicians will be used to reinforce learned concepts and motivate participants to achieve their goals. The first two sessions will follow a standardized curriculum, while the last three sessions will include development and implementation of tailored activities designed to address systems barriers and meet individual practice needs.

Behavioral: DOSE-CC Intervention: Educational Sessions

Interventions

DOSE-CC Intervention: Educational Sessions BEHAVIORAL

Session 1: Introduction to the project, and feedback/discussion around clinic screening rates. Session 2: Education on cervical cancer, impact of screening on cancer prevention and health equity, different methods of screening, and recent updates to screening and follow-up guidelines. Session 3: Action plan development. Sessions 4 and 5: Quality improvement through plan-do-study-act cycles and assessment of the success of the action plan.

DOSE-CC Intervention: Educational Sessions

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Active patients (defined as having a primary care provider assigned at the clinical site and with an appointment in the past 18 months)
• Eligible for cervical cancer screening (e.g., has a cervix and not up to date with screening)

You may not qualify if:

• None

Sponsors & Collaborators

• Boston Medical Center: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Lunze Karsten, MD, MPH

  Boston Medical Center, General Internal Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Perkins, MD, MSc

CONTACT

617-568-4441; rebecca.perkins1@tuftsmedicine.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Step wedge randomized trial

Study Record Dates

• First Submitted: November 6, 2025
• First Posted: November 10, 2025
• Study Start (Estimated): May 1, 2027
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): January 1, 2030
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share