Development of Systems and Education for Cervical Cancer Prevention (DOSE-CC)
NCT ID: NCT07226037
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
80000 participants
INTERVENTIONAL
2027-05-31
2030-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
First, the investigators' successful primary prevention intervention will be adapted to address cervical cancer screening (DOSE-CC \[Development of Systems and Education for Cervical Cancer Prevention\]). Key stakeholders will be interviewed to explore facilitators and barriers to screening and follow-up at the patient, clinician, and healthcare setting levels and use these findings and Advisory Board input to develop the DOSE-CC intervention.
Second, the investigators will validate DOSE-CC using a Hybrid Type 1 effectiveness-implementation, stepped wedge randomized controlled trial design of the 6-month intervention, reaching over 40,000 patients.
Third, guided by the RE-AIM QuEST (Reach, Effectiveness, Adoption, Implementation Qualitative Evaluation for Systemic Translation) framework, the investigators will conduct semi-structured interviews of key stakeholders to examine intervention reach, adoption, implementation, maintenance and sustainability, and barriers and facilitators of intervention success.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
DOSE-CC Intervention: Educational Sessions
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.
DOSE-CC Intervention: Educational Sessions
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
DOSE-CC Intervention: Educational Sessions
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Eligible for cervical cancer screening (e.g., has a cervix and not up to date with screening)
Exclusion Criteria
21 Years
65 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Boston Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lunze Karsten, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Boston Medical Center, General Internal Medicine
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H-46139
Identifier Type: -
Identifier Source: org_study_id