An interventional study of Tools and Training for Cancer Control and Enhancing Social Capital and Civic Engagement in Breast Cancer Screening, Cervical Cancer Screening and Colon Cancer Screening, sponsored by Harvard School of Public Health (HSPH). Enrolling by invitation at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by Harvard School of Public Health (HSPH) · Not applicable, Interventional, and Prevention
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.
276 studies on the registry are indexed under Tobacco Use Cessation; 45 are open to participants now.
This study's planned enrollment of 100 is below the median of 226 across 256 interventional studies indexed under Tobacco Use Cessation.
Browse Tobacco Use Cessation studies →Harvard School of Public Health (HSPH) is the lead sponsor of 154 studies on the registry; 10 are open to participants now.
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Study participants include community health center and community partner staff participating in surveys and interviews about the implementation of the intervention.
Inclusion Criteria:
Exclusion Criteria:
Patients will not be individually recruited for the study because the intervention is being offered as part of routine care.
Behavioral: Tools and Training for Cancer Control · Behavioral: Enhancing Social Capital and Civic Engagement
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).
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.
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.
Patients Screened for Colorectal Cancer
% patients who are up to date on colorectal cancer screening from EMR
Time frame: 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
Time frame: 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
Time frame: change from baseline to end of intervention period, an average of 1 year
Patients Offered Pharmacotherapy for Smoking Cessation
% patients offered pharmacotherapy from EMR
Time frame: change from baseline to end of intervention period, an average of 1 year
Acceptability of the intervention
Self reported via staff survey
Time frame: Post intervention, 1 year follow up
Feasibility of the intervention
Self-reported via staff survey
Time frame: Post intervention, 1 year follow up
Plan to share: 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).
Time frame: Data will be stored for 7 years.
Access criteria: Outside investigators will need an approved concept proposal to analyze study data and spend the requisite time with study staff to learn about the data elements needed to conduct the proposed analysis. With the assistance from the study's analytic team, s/he will draft a detailed analysis plan and present to the core group of co-investigators. The discussion at this meeting ensures adequate knowledge of the data, and the presenter gains much insight into how the analysis can be most useful and how it relates to previous analyses. Once the plan is approved by this group, it must also be approved by the CHCs that provide the de-identified data. Following approval by the appropriate IRBs and confirmation that it meets HIPAA requirements, s/he may sign a DUA to use a secure, de-identified dataset to complete only the approved analyses and write the manuscript(s) offsite. A formal data analysis plan application and DUA are available. Requests should be directed to jdaly@hsph.harvard.edu.
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Jun 2028, 24 months after the start.
Of 115 non-industry interventional studies with no phase under Tobacco Use Cessation, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 40. This study's planned 24 months is close to that.
Counting every sponsor, half of 116 studies reached it within 24 months; a quarter within 15 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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