Cervical Cancer ScreeningDOSE-CCNCT07226037
Development of Systems and Education for Cervical Cancer Prevention (DOSE-CC)
A study testing DOSE-CC Intervention: Educational Sessions in people with Cervical Cancer Screening and Cervical Cancer, run by Boston Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years, women only
- Conditions the study is for
- Cervical Cancer Screening, Cervical Cancer
- What is being tested?
- DOSE-CC Intervention: Educational Sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80,000 participants
- Where
- No sites listed yet
- Study dates
- May 2027to Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- None
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
Read the detailed description
The research will specifically address the following objectives.
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
- Cervical Cancer Screening, Cervical Cancer
- Being tested
- DOSE-CC Intervention: Educational Sessions
- Keywords
- DOSE-CC, cervical cancer, prevention
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DOSE-CC Intervention: Educational SessionsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: DOSE-CC Intervention: Educational Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who receive cervical cancer screening
Defined as a cervical cytology (Pap test) and/or HPV test for those who are due
Measured: 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
(e.g., receipt of colposcopy, treatment, additional follow-up testing)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study startMay 2027 (estimated)
- Primary completionMay 2029 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Step wedge randomized trial
- Masking
- None (open label)
- Enrolment
- 80,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lunze Karsten, MD, MPH, Principal investigator, Boston Medical Center, General Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07226037
- Sponsor's protocol ID
- H-46139
- Other IDs
- R01CA299475
- Acronym
- DOSE-CC
- Status last verified
- Oct 2026
- First submitted
- 6 Nov 2025
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Systems and Education for Cervical Cancer Prevention (DOSE-CC)
- ClinicalTrials.gov ID
- NCT07226037
- Acronym / sponsor ID
- DOSE-CC / H-46139
- Conditions
- Cervical Cancer Screening, Cervical Cancer
- Keywords
- DOSE-CC, cervical cancer, prevention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80,000 participants (estimated)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2027 (estimated)
- Primary completion
- May 2029 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 10 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The research will specifically address the following objectives.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Step wedge randomized trial
| Arm | Type | Receives |
|---|---|---|
| DOSE-CC Intervention: Educational Sessions | Experimental | Behavioral: DOSE-CC Intervention: Educational SessionsThe 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DOSE-CC Intervention: Educational SessionsSession 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. | Behavioural | DOSE-CC Intervention: Educational Sessions |
Primary outcome
Number of participants who receive cervical cancer screening
Time frame: 1-5 years, depending on prior test and result
Defined as a cervical cytology (Pap test) and/or HPV test for those who are due
1 secondary outcome
Number of participants with diagnostic resolution among those with abnormal screening results per 2019 ASCCP guidelines
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lunze Karsten, MD, MPH principal investigator
Boston Medical Center, General Internal Medicine
Questions about this trial
What is this clinical trial studying?
A study testing DOSE-CC Intervention: Educational Sessions in people with Cervical Cancer Screening and Cervical Cancer, run by Boston Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca Perkins, MD, MSc (617-568-4441, rebecca.perkins1@tuftsmedicine.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who receive cervical cancer screening (time frame: 1-5 years, depending on prior test and result). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.