Breast Cancer ScreeningNCT07592793
Community Gateway to Health Study
A study testing Enhancing Social Capital and Civic Engagement in people with Breast Cancer Screening and Cervical Cancer Screening, run by Harvard School of Public Health (HSPH) at 2 sites in United States.
Trial summary
The goal of this study is to evaluate the impact of a multi-level intervention on cancer prevention and social determinants of health outcomes. This partnership between academic and community-based researchers aims to link community health centers and communities in ways that maximize both civic engagement and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Screening, Cervical Cancer Screening, Colon Cancer Screening
- What is being tested?
- Enhancing Social Capital and Civic Engagement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Jun 2026to Jul 2029
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Community health center staff or community partners
- Age 18 or older
Who cannot join
- Under 18
- Patients will not be individually recruited for the study because the intervention is being offered as part of routine care.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Harvard TH Chan School of Public Health
Boston, Massachusetts, 02115
Caring Health Center
Springfield, Massachusetts, 01103
About this study
The goal of this study is to evaluate the impact of a multi-level intervention on cancer prevention and social determinants of health outcomes. This partnership between academic and community-based researchers aims to link community health centers and communities in ways that maximize both civic engagement and participation in cancer control care. The system-level intervention consists of two components: (1) provision of community health center systems-level tools for cancer screening (breast, cervical, colorectal) and tobacco cessation treatment gaps; and (2) digital access screening and navigation. These interventions will be delivered via usual care.
- Conditions
- Breast Cancer Screening, Cervical Cancer Screening, Colon Cancer Screening, Tobacco Cessation
- Being tested
- Tools and Training for Cancer Control, Enhancing Social Capital and Civic Engagement
- Medical subject headings
- Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tools and Training for Cancer ControlBehavioural
This system level intervention consists of two components: (1) provision of community health center systems-level tools for cancer screening (breast, cervical, colorectal) and tobacco cessation treatment gaps; and (2) digital access screening and navigation.
Enhancing Social Capital and Civic EngagementBehavioural
This community level intervention consists of a patient referral from a community health center to a community organization focused on building social capital and civic engagement to test the impact of connecting clinical and community resources explicitly for patients.
| Study group | Role | What they receive |
|---|---|---|
| Multilevel Intervention | Experimental | Not described Receives: Behavioral: Tools and Training for Cancer Control; Behavioral: Enhancing Social Capital and Civic Engagement |
| Usual Care | No intervention | In this stepped wedge design, all sites have a period of being in usual care. Six sites then have periods of providing the intervention and six sites remain comparison sites (i.e. usual care). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients Screened for Colorectal Cancer
% patients who are up to date on colorectal cancer screening from EMR
Measured: change from baseline to end of intervention period, an average of 1 year
Patients Screened for Breast Cancer
% patients who are up to date on breast cancer screening from EMR
Measured: change from baseline to end of intervention period, an average of 1 year
Patients Screened for Cervical Cancer
% patients who are up to date on cervical cancer screening from EMR
Measured: change from baseline to end of intervention period, an average of 1 year
Patients Offered Pharmacotherapy for Smoking Cessation
% patients offered pharmacotherapy from EMR
Measured: change from baseline to end of intervention period, an average of 1 year
Secondary outcomes (2)
Acceptability of the intervention
Self reported via staff survey
Measured: Post intervention, 1 year follow up
Feasibility of the intervention
Self-reported via staff survey
Measured: Post intervention, 1 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start2 Jun 2026
- Primary completionJun 2028 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer ScreeningStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Sequential
- Model description
- This study uses a cluster-randomized, stepped-wedge design
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Caring Health Center, Massachusetts League of Community Health Centers
- Responsible party
- Principal investigator, Rebekka Lee, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07592793
- Sponsor's protocol ID
- 241740
- Other IDs
- U19CA291431
- Status last verified
- Jul 2026
- First submitted
- 4 May 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data that underlie the results reported here, after de-identification. Individual staff/partner data on implementation will be made publicly available. Patient data can be made available upon request and appropriate approvals (see below).
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Gateway to Health Study
- ClinicalTrials.gov ID
- NCT07592793
- Acronym / sponsor ID
- 241740
- Conditions
- Breast Cancer Screening, Cervical Cancer Screening, Colon Cancer Screening, Tobacco Cessation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Caring Health Center, Massachusetts League of Community Health Centers
- Study start
- 2 Jun 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 18 May 2026 (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.
The goal of this study is to evaluate the impact of a multi-level intervention on cancer prevention and social determinants of health outcomes. This partnership between academic and community-based researchers aims to link community health centers and communities in ways that maximize both civic engagement and participation in cancer control care. The system-level intervention consists of two components: (1) provision of community health center systems-level tools for cancer screening (breast, cervical, colorectal) and tobacco cessation treatment gaps; and (2) digital access screening and navigation. These interventions will be delivered via usual care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study uses a cluster-randomized, stepped-wedge design
| Arm | Type | Receives |
|---|---|---|
| Multilevel Intervention | Experimental | Behavioral: Tools and Training for Cancer Control, Behavioral: Enhancing Social Capital and Civic Engagement |
| Usual Care | No intervention | –In this stepped wedge design, all sites have a period of being in usual care. Six sites then have periods of providing the intervention and six sites remain comparison sites (i.e. usual care). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Community health center staff or community partners
- Age 18 or older
Key exclusion criteria (2 listed)
- Under 18
- Patients will not be individually recruited for the study because the intervention is being offered as part of routine care.
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 |
|---|---|---|
| Tools and Training for Cancer ControlThis system level intervention consists of two components: (1) provision of community health center systems-level tools for cancer screening (breast, cervical, colorectal) and tobacco cessation treatment gaps; and (2) digital access screening and navigation. | Behavioural | Multilevel Intervention |
| Enhancing Social Capital and Civic EngagementThis community level intervention consists of a patient referral from a community health center to a community organization focused on building social capital and civic engagement to test the impact of connecting clinical and community resources explicitly for patients. | Behavioural | Multilevel Intervention |
Primary outcome
Patients Screened for Colorectal Cancer
Time frame: change from baseline to end of intervention period, an average of 1 year
% patients who are up to date on colorectal cancer screening from EMR
Patients Screened for Breast Cancer
Time frame: change from baseline to end of intervention period, an average of 1 year
% patients who are up to date on breast cancer screening from EMR
Patients Screened for Cervical Cancer
Time frame: change from baseline to end of intervention period, an average of 1 year
% patients who are up to date on cervical cancer screening from EMR
Patients Offered Pharmacotherapy for Smoking Cessation
Time frame: change from baseline to end of intervention period, an average of 1 year
% patients offered pharmacotherapy from EMR
2 secondary outcomes
Acceptability of the intervention
Time frame: Post intervention, 1 year follow up
Feasibility of the intervention
Time frame: Post intervention, 1 year follow up
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 6 Jul 2026.
- Individual participant dataSharing planned: Yes. Data that underlie the results reported here, after de-identification. Individual staff/partner data on implementation will be made publicly available. Patient data can be made available upon request and appropriate approvals (see below).
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Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8
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Individuals on Hormone Therapy Breast Cancer Screening Pilot
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RecruitingPhase 2
Detecting Tumor DNA in the Blood of HR+/HER2-low Metastatic Breast Cancer Patients to Find Candidates for T-DXd Therapy
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhancing Social Capital and Civic Engagement in people with Breast Cancer Screening and Cervical Cancer Screening, run by Harvard School of Public Health (HSPH) at 2 sites in United States.
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 2 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: enrolling by invitation, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients Screened for Colorectal Cancer (time frame: change from baseline to end of intervention period, an average of 1 year). The study lists 4 primary outcomes in all. 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 6 Jul 2026.