Breast CarcinomaNCT06666192
The Ohio State University (OSU) SCREEN Community Program
A study testing Cancer Screening, Discussion and Educational Activity in people with Breast Carcinoma and Cervical Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This clinical trial develops and tests how well a multi-level intervention (MLI), The Ohio State University (OSU) SCREEN Community Program, works to increase screening and follow-up for breast, cervical and colorectal (CRC) cancer among low-income and un/underinsured female residents in three counties in Central Ohio. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Breast Carcinoma, Cervical Carcinoma, Colorectal Carcinoma
- What is being tested?
- Cancer Screening, Discussion and Educational Activity
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,067 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2024to 31 Dec 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Level 1 is the health clinics (Helping Hands [pilot]; 6 Lower Lights clinics). Clinics are eligible if they provide preventive health care to residents of the targeted census tracts.
- Level 2 focuses on health care providers (physicians, nurses, physician assistants [PA]/nurse practitioners [NPs]) and office staff practicing at participating clinics who are involved in the screening and/or screening referral process (determined by individual clinical sites) and can speak, read, and write English
- Patients (Level 3) are the recipients of health care and screening interventional strategies implemented by clinics and providers.
- Level 4 is the community to include residents in targeted census tracts around each clinic.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
The Ohio State University Comprehensive Cancer Center contact
United States1 site, 1 recruiting
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Electra D. Paskett, PhD, 614-293-3917, Electra.Paskett@osumc.edu
Electra D. Paskett
About this study
Official title: A Multi-Level Intervention for Improving Screening Rates of Breast, Cervical and Colorectal Cancer in Women in Low-Income Communities
This clinical trial develops and tests how well a multi-level intervention (MLI), The Ohio State University (OSU) SCREEN Community Program, works to increase screening and follow-up for breast, cervical and colorectal (CRC) cancer among low-income and un/underinsured female residents in three counties in Central Ohio. In Ohio, incidence and mortality rates for breast, cervical and CRC are higher than or similar to the national average; in addition, underserved populations - minority, rural and low-income women - have higher rates of these cancers. Screening can detect precancerous colorectal and cervical lesions and other early-stage cancers when treatment is less intensive and more successful and is known to reduce mortality rates for breast, cervical, and CRC, however many of these women lack access to health care and screenings. This MLI includes clinic-based components, such as patient education, as well as community-based strategies, such as media programs and training health workers, that can increase rates of guideline-recommended breast, cervical and CRC screening and follow-ups in underserved populations. The OSU SCREEN Community Program may be an effective way to improve breast, cervical and CRC screenings among underserved women in Ohio.
Read the detailed description
PRIMARY OBJECTIVES:
- Understand local factors and context relevant to breast, cervical and CRC screening and follow-up (including referral-to-care) and develop an MLI planning and implementation pathway for use by partner health centers and communities (Year 1).
II. Pilot test and further refine the MLI planning and implementation process in one clinic (Years 1 \& 2).
III. Test the final MLI planning and implementation process in a group randomized, delayed intervention trial to assess the impact of the customized MLI on increasing rates of guideline recommended breast, cervical and CRC screening and follow-up for abnormal tests (Years 2, 3 and 4).
IV. Assess sustainability of the MLI (Years 4 and 5).
OUTLINE:
PHASE I (PLANNING): Providers and community members review MLI materials and participate in focus groups and interviews to discuss challenges to being screened, what community members know about cancer and screening and what should be included in a program to increase screening over 30-60 minutes on study. A clinic champion will be identified during the interview to lead, advise, and oversee the implementation of the MLI at their clinic location.
PHASE II (PILOT): Participants are assigned to 1 of 4 arms.
ARM I (HEALTH CLINICS): The clinic champion coordinates planning sessions, staff training, and overall implementation and planning for the MLI within each health clinic. Health clinics may integrate new activities into usual clinic processes such as the use of the electronic health record (EHR) to identify age-eligible patients in need of breast, cervical and/or CRC screening, reminder systems built into the EHR that can be sent to both providers and patients for screening and follow-up, and EHR information alerts for providers about patients who have positive fecal immunochemical test (FITs) or a positive Pap test or mammogram on study. Additionally, health clinics may incorporate risk assessments (via paper or within the EHR) for all patients eligible for breast, cervical and/or CRC screening, promote screening via web-based or health portal messaging, promote annual wellness visits (during which screening should be discussed), and offer incentives for completing needed cancer screening on study.
ARM II (HEALTH CARE PROVIDERS): Providers participate in educational sessions that include self-administered pre-test surveys and discussions that assess screening knowledge, beliefs, attitudes, and practices, over one hour on study. Providers may also undergo coaching calls and one-on-one discussions to help tailor information and its delivery to the needs of providers and practices and are taught how to use clinic-based scheduling and reminder systems to help facilitate screening and follow-up actions.
ARM III (PATIENTS): Patients receive educational materials about screening and screening recommendations via mail and during in-person visits, and a web link for the developed small media website on study. Patients participate in discussions about screening and are offered any test for which they are not up to date and appropriate follow-up is conducted by designated staff on study. Patients who choose to undergo testing and receive a positive result receive a letter from the clinic and a call from the designated clinic staff member on study.
ARM IV (COMMUNITY): Communities receive educational materials (e.g., posters) and outreach activities to promote screening (e.g., health fairs, farmers' markets, inflatable colon tours, community seminars) and receive access to a community health worker (CHW) for one-on-one education about screening on study.
PHASE III and IV: Participating clinics and surrounding communities are randomized to 1 of 2 arms.
ARM V (EARLY INTERVENTION WAVE): Participating clinics and communities participate in the MLI early (years 2-3) for up to 30 months.
ARM VI (DELAYED INTERVENTION WAVE): Participating clinics and communities participate in the MLI 12 months later (years 3-4) for at least 12 months.
- Conditions
- Breast Carcinoma, Cervical Carcinoma, Colorectal Carcinoma
- Being tested
- Cancer Screening, Discussion, Educational Activity, Educational Intervention, Focus Group
- Medical subject headings
- Breast Neoplasms, Uterine Cervical Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cancer ScreeningOther
Also called Cancer Screening for Patients, Early Cancer Detection, Screening, Screening of Cancer
Undergo cancer screening
DiscussionOther
Also called Discuss
Participate in discussions
Educational ActivityOther
Receive coaching calls
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive educational materials
Focus GroupBehavioural
Participate in focus group
Health Care DeliveryOther
Also called Care Delivery, Health Services Delivery, Other, Healthcare Delivery
Integrate new activities into usual clinic processes
Health PromotionOther
Also called Health Promotion (Salutogenesis), Health Promotion and Wellness, Mindfulness Health Promotion, Salutogenesis
Promote screening and wellness visits
Health Promotion and EducationOther
Participate in educational sessions
Health Promotion and EducationOther
Participate in early wave MLI
Health Promotion and EducationOther
Participate in late wave MLI
Health Risk AssessmentBehavioural
Also called Risk Assessment
Incorporate risk assessments
ImplementationProcedure or surgery
Implement MLI
Informational InterventionOther
Review MLI materials
Internet-Based InterventionOther
Receive educational online materials
InterviewOther
Participate in interview
OutreachBehavioural
Also called Outreach Strategy
Receive outreach activities
Patient NavigationBehavioural
Also called Patient Navigator Program
Receive access to CHW
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Phase I, Planning Phase (MLI material, focus group, interview) | Other | Providers and community members review MLI materials and participate in focus groups and interviews to discuss challenges to being screened, what community members know about cancer and screening and what should be included in a program to increase screening over 30-60 minutes on study. A clinic champion will be identified during the interview to lead, advise, and oversee the implementation of the MLI at their clinic location. Receives: Behavioral: Focus Group; Other: Informational Intervention; Other: Interview |
| Phase II, Arm I (Health Clinics) | Active comparator | The clinic champion coordinates planning sessions, staff training, and overall implementation and planning for the MLI within each health clinic. Health clinics may integrate new activities into usual clinic processes such as the use of the EHR to identify age-eligible patients in need of breast, cervical and/or CRC screening, reminder systems built into the EHR that can be sent to both providers and patients for screening and follow-up, and EHR information alerts for providers about patients who have positive FITs or a positive Pap test or mammogram on study. Additionally, health clinics may incorporate risk assessments (via paper or within the EHR) for all patients eligible for breast, cervical and/or CRC screening, promote screening via web-based or health portal messaging, promote annual wellness visits (during which screening should be discussed), and offer incentives for completing needed cancer screening on study. Receives: Other: Health Care Delivery; Other: Health Promotion; Behavioral: Health Risk Assessment; Procedure: Implementation; Behavioral: Patient Navigation |
| Phase II, Arm II (Health Care Providers) | Active comparator | Providers participate in educational sessions that include self-administered pre-test surveys and discussions that assess screening knowledge, beliefs, attitudes, and practices, over one hour on study. Providers may also undergo coaching calls and one-on-one discussions to help tailor information and its delivery to the needs of providers and practices and are taught how to use clinic-based scheduling and reminder systems to help facilitate screening and follow-up actions. Receives: Other: Discussion; Other: Educational Activity; Other: Health Care Delivery; Other: Health Promotion and Education; Other: Survey Administration |
| Phase II, Arm III (Patients) | Active comparator | Patients receive educational materials about screening and screening recommendations via mail and during in-person visits, and a web link for the developed small media website on study. Patients participate in discussions about screening and are offered any test for which they are not up to date and appropriate follow-up is conducted by designated staff on study. Patients who choose to undergo testing and receive a positive result receive a letter from the clinic and a call from the designated clinic staff member on study. Receives: Other: Cancer Screening; Other: Discussion; Other: Educational Intervention; Other: Internet-Based Intervention |
| Phase II, Arm IV (Community) | Active comparator | Community receive educational materials (e.g., posters) and outreach activities to promote screening (e.g., health fairs, farmers' markets, inflatable colon tours, community seminars) and receive access to a CHW for one-on-one education about screening on study. Receives: Other: Discussion; Other: Educational Intervention; Behavioral: Outreach; Behavioral: Patient Navigation |
| Phase III and IV, Arm V (MLI Early Wave) | Experimental | Participating clinics and communities participate in the MLI early (years 2-3) for up to 30 months. Receives: Other: Health Promotion and Education |
| Phase III and IV, Arm VI (MLI Delayed Wave) | Experimental | Participating clinics and communities participate in the MLI 12 months later (years 3-4) for at least 12 months. Receives: Other: Health Promotion and Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Up to date (UTD) status for all three screenings (Early Intervention Wave)
Will be assessed by the difference in proportions of being UTD with all age-appropriate screening tests using electronic health record (EHR) data. Rates will be examined by age, race/ethnicity, residence, payer status, provider, time since last visit, and rates of other cancer screening. Repeated measure Generalized Estimating Equations (GEE) models with compound symmetry correlation structure and robust variance will be used to compare change between the early and delayed intervention groups adjusting for baseline UTD screening rates of the targeted communities. Adjustment for baseline UTD screening rates and rates of follow up for abnormal test will control for any differences by intervention group due to chance and will increase power by decreasing the standard error of the treatment effect. To account for differences in number of respondents across targeted communities, GEE models will be weighted using an approach described by Johnson et al.
Measured: At baseline and at the end of the Implementation Phase (up to 4 years)
Status of follow-up for abnormal tests (Early Intervention Wave)
Will be assessed by the difference in follow-up rates for abnormal tests using EHR data. GEE models with compound symmetry correlation structure and robust variance will be used to compare change between the early and delayed intervention groups adjusting for baseline UTD screening rates of the targeted communities. Adjustment for baseline UTD screening rates and rates of follow up for abnormal test will control for any differences by intervention group due to chance and will increase power by decreasing the standard error of the treatment effect. To account for differences in number of respondents across targeted communities, GEE models will be weighted using an approach described by Johnson et al.
Measured: At baseline and at the end of the Implementation Phase (up to 4 years)
Secondary outcomes (1)
UTD screening status for all three cancers and follow up rates for abnormal tests
Will be assessed among age-appropriate residents of targeted census tracts. The individual-level UTD status pre- and post-intervention will be obtained from cross-sectional surveys, and it will be defined based on the age-specific United States Preventive Services Task Force Cancer Screening Guidelines screening recommendations for each cancer. A two-level hierarchical mixed-effects logistic regression model will be used to compare the UTD odds between the early and delayed intervention groups. In this two-level design, participants are the level one unit while the clinic areas are the level two unit of analysis, with all subjects in each cluster receiving either the early or delayed intervention. This design will allow to examine the effectiveness of the multi-level intervention at the individual- and cluster levels.
Measured: At the end of early intervention (up to 2.5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start12 Mar 2024
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 2,067 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Principal investigator, Electra Paskett, Ohio State University Comprehensive Cancer Center
- Investigators
- Electra D Paskett, PhD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06666192
- Sponsor's protocol ID
- OSU-23400
- Other IDs
- NCI-2024-07400
- Status last verified
- Dec 2025
- First submitted
- 29 Oct 2024
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Level Intervention for Improving Screening Rates of Breast, Cervical and Colorectal Cancer in Women in Low-Income Communities
- ClinicalTrials.gov ID
- NCT06666192
- Acronym / sponsor ID
- OSU-23400
- Conditions
- Breast Carcinoma, Cervical Carcinoma, Colorectal Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,067 participants (estimated)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 30 Oct 2024 (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.
This clinical trial develops and tests how well a multi-level intervention (MLI), The Ohio State University (OSU) SCREEN Community Program, works to increase screening and follow-up for breast, cervical and colorectal (CRC) cancer among low-income and un/underinsured female residents in three counties in Central Ohio. In Ohio, incidence and mortality rates for breast, cervical and CRC are higher than or similar to the national average; in addition, underserved populations - minority, rural and low-income women - have higher rates of these cancers. Screening can detect precancerous colorectal and cervical lesions and other early-stage cancers when treatment is less intensive and more successful and is known to reduce mortality rates for breast, cervical, and CRC, however many of these women lack access to health care and screenings. This MLI includes clinic-based components, such as patient education, as well as community-based strategies, such as media programs and training health workers, that can increase rates of guideline-recommended breast, cervical and CRC screening and follow-ups in underserved populations. The OSU SCREEN Community Program may be an effective way to improve breast, cervical and CRC screenings among underserved women in Ohio.
Detailed description
PRIMARY OBJECTIVES:
- Understand local factors and context relevant to breast, cervical and CRC screening and follow-up (including referral-to-care) and develop an MLI planning and implementation pathway for use by partner health centers and communities (Year 1).
II. Pilot test and further refine the MLI planning and implementation process in one clinic (Years 1 \& 2).
III. Test the final MLI planning and implementation process in a group randomized, delayed intervention trial to assess the impact of the customized MLI on increasing rates of guideline recommended breast, cervical and CRC screening and follow-up for abnormal tests (Years 2, 3 and 4).
IV. Assess sustainability of the MLI (Years 4 and 5).
OUTLINE:
PHASE I (PLANNING): Providers and community members review MLI materials and participate in focus groups and interviews to discuss challenges to being screened, what community members know about cancer and screening and what should be included in a program to increase screening over 30-60 minutes on study. A clinic champion will be identified during the interview to lead, advise, and oversee the implementation of the MLI at their clinic location.
PHASE II (PILOT): Participants are assigned to 1 of 4 arms.
ARM I (HEALTH CLINICS): The clinic champion coordinates planning sessions, staff training, and overall implementation and planning for the MLI within each health clinic. Health clinics may integrate new activities into usual clinic processes such as the use of the electronic health record (EHR) to identify age-eligible patients in need of breast, cervical and/or CRC screening, reminder systems built into the EHR that can be sent to both providers and patients for screening and follow-up, and EHR information alerts for providers about patients who have positive fecal immunochemical test (FITs) or a positive Pap test or mammogram on study. Additionally, health clinics may incorporate risk assessments (via paper or within the EHR) for all patients eligible for breast, cervical and/or CRC screening, promote screening via web-based or health portal messaging, promote annual wellness visits (during which screening should be discussed), and offer incentives for completing needed cancer screening on study.
ARM II (HEALTH CARE PROVIDERS): Providers participate in educational sessions that include self-administered pre-test surveys and discussions that assess screening knowledge, beliefs, attitudes, and practices, over one hour on study. Providers may also undergo coaching calls and one-on-one discussions to help tailor information and its delivery to the needs of providers and practices and are taught how to use clinic-based scheduling and reminder systems to help facilitate screening and follow-up actions.
ARM III (PATIENTS): Patients receive educational materials about screening and screening recommendations via mail and during in-person visits, and a web link for the developed small media website on study. Patients participate in discussions about screening and are offered any test for which they are not up to date and appropriate follow-up is conducted by designated staff on study. Patients who choose to undergo testing and receive a positive result receive a letter from the clinic and a call from the designated clinic staff member on study.
ARM IV (COMMUNITY): Communities receive educational materials (e.g., posters) and outreach activities to promote screening (e.g., health fairs, farmers' markets, inflatable colon tours, community seminars) and receive access to a community health worker (CHW) for one-on-one education about screening on study.
PHASE III and IV: Participating clinics and surrounding communities are randomized to 1 of 2 arms.
ARM V (EARLY INTERVENTION WAVE): Participating clinics and communities participate in the MLI early (years 2-3) for up to 30 months.
ARM VI (DELAYED INTERVENTION WAVE): Participating clinics and communities participate in the MLI 12 months later (years 3-4) for at least 12 months.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Phase I, Planning Phase (MLI material, focus group, interview) | Other | Behavioral: Focus Group, Other: Informational Intervention, Other: InterviewProviders and community members review MLI materials and participate in focus groups and interviews to discuss challenges to being screened, what community members know about cancer and screening and what should be included in a program to increase screening over 30-60 minutes on study. A clinic champion will be identified during the interview to lead, advise, and oversee the implementation of the MLI at their clinic location. |
| Phase II, Arm I (Health Clinics) | Active comparator | Other: Health Care Delivery, Other: Health Promotion, Behavioral: Health Risk Assessment, Procedure: Implementation, Behavioral: Patient NavigationThe clinic champion coordinates planning sessions, staff training, and overall implementation and planning for the MLI within each health clinic. Health clinics may integrate new activities into usual clinic processes such as the use of the EHR to identify age-eligible patients in need of breast, cervical and/or CRC screening, reminder systems built into the EHR that can be sent to both providers and patients for screening and follow-up, and EHR information alerts for providers about patients who have positive FITs or a positive Pap test or mammogram on study. Additionally, health clinics may incorporate risk assessments (via paper or within the EHR) for all patients eligible for breast, cervical and/or CRC screening, promote screening via web-based or health portal messaging, promote annual wellness visits (during which screening should be discussed), and offer incentives for completing needed cancer screening on study. |
| Phase II, Arm II (Health Care Providers) | Active comparator | Other: Discussion, Other: Educational Activity, Other: Health Care Delivery, Other: Health Promotion and Education, Other: Survey AdministrationProviders participate in educational sessions that include self-administered pre-test surveys and discussions that assess screening knowledge, beliefs, attitudes, and practices, over one hour on study. Providers may also undergo coaching calls and one-on-one discussions to help tailor information and its delivery to the needs of providers and practices and are taught how to use clinic-based scheduling and reminder systems to help facilitate screening and follow-up actions. |
| Phase II, Arm III (Patients) | Active comparator | Other: Cancer Screening, Other: Discussion, Other: Educational Intervention, Other: Internet-Based InterventionPatients receive educational materials about screening and screening recommendations via mail and during in-person visits, and a web link for the developed small media website on study. Patients participate in discussions about screening and are offered any test for which they are not up to date and appropriate follow-up is conducted by designated staff on study. Patients who choose to undergo testing and receive a positive result receive a letter from the clinic and a call from the designated clinic staff member on study. |
| Phase II, Arm IV (Community) | Active comparator | Other: Discussion, Other: Educational Intervention, Behavioral: Outreach, Behavioral: Patient NavigationCommunity receive educational materials (e.g., posters) and outreach activities to promote screening (e.g., health fairs, farmers' markets, inflatable colon tours, community seminars) and receive access to a CHW for one-on-one education about screening on study. |
| Phase III and IV, Arm V (MLI Early Wave) | Experimental | Other: Health Promotion and EducationParticipating clinics and communities participate in the MLI early (years 2-3) for up to 30 months. |
| Phase III and IV, Arm VI (MLI Delayed Wave) | Experimental | Other: Health Promotion and EducationParticipating clinics and communities participate in the MLI 12 months later (years 3-4) for at least 12 months. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Level 1 is the health clinics (Helping Hands [pilot]; 6 Lower Lights clinics). Clinics are eligible if they provide preventive health care to residents of the targeted census tracts.
- Level 2 focuses on health care providers (physicians, nurses, physician assistants [PA]/nurse practitioners [NPs]) and office staff practicing at participating clinics who are involved in the screening and/or screening referral process (determined by individual clinical sites) and can speak, read, and write English
- Patients (Level 3) are the recipients of health care and screening interventional strategies implemented by clinics and providers.
- Level 4 is the community to include residents in targeted census tracts around each clinic.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Cancer ScreeningAlso: Cancer Screening for Patients, Early Cancer Detection, Screening, Screening of CancerUndergo cancer screening | Other | Phase II, Arm III (Patients) |
| DiscussionAlso: DiscussParticipate in discussions | Other | Phase II, Arm II (Health Care Providers), Phase II, Arm III (Patients), Phase II, Arm IV (Community) |
| Educational ActivityReceive coaching calls | Other | Phase II, Arm II (Health Care Providers) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive educational materials | Other | Phase II, Arm III (Patients), Phase II, Arm IV (Community) |
| Focus GroupParticipate in focus group | Behavioural | Phase I, Planning Phase (MLI material, focus group, interview) |
| Health Care DeliveryAlso: Care Delivery, Health Services Delivery, Other, Healthcare DeliveryIntegrate new activities into usual clinic processes | Other | Phase II, Arm I (Health Clinics), Phase II, Arm II (Health Care Providers) |
| Health PromotionAlso: Health Promotion (Salutogenesis), Health Promotion and Wellness, Mindfulness Health Promotion, SalutogenesisPromote screening and wellness visits | Other | Phase II, Arm I (Health Clinics) |
| Health Promotion and EducationParticipate in educational sessions | Other | Phase II, Arm II (Health Care Providers) |
| Health Promotion and EducationParticipate in early wave MLI | Other | Phase III and IV, Arm V (MLI Early Wave) |
| Health Promotion and EducationParticipate in late wave MLI | Other | Phase III and IV, Arm VI (MLI Delayed Wave) |
| Health Risk AssessmentAlso: Risk AssessmentIncorporate risk assessments | Behavioural | Phase II, Arm I (Health Clinics) |
| ImplementationImplement MLI | Procedure or surgery | Phase II, Arm I (Health Clinics) |
| Informational InterventionReview MLI materials | Other | Phase I, Planning Phase (MLI material, focus group, interview) |
| Internet-Based InterventionReceive educational online materials | Other | Phase II, Arm III (Patients) |
| InterviewParticipate in interview | Other | Phase I, Planning Phase (MLI material, focus group, interview) |
| OutreachAlso: Outreach StrategyReceive outreach activities | Behavioural | Phase II, Arm IV (Community) |
| Patient NavigationAlso: Patient Navigator ProgramReceive access to CHW | Behavioural | Phase II, Arm I (Health Clinics), Phase II, Arm IV (Community) |
| Survey AdministrationAncillary studies | Other | Phase II, Arm II (Health Care Providers) |
Primary outcome
Up to date (UTD) status for all three screenings (Early Intervention Wave)
Time frame: At baseline and at the end of the Implementation Phase (up to 4 years)
Will be assessed by the difference in proportions of being UTD with all age-appropriate screening tests using electronic health record (EHR) data. Rates will be examined by age, race/ethnicity, residence, payer status, provider, time since last visit, and rates of other cancer screening. Repeated measure Generalized Estimating Equations (GEE) models with compound symmetry correlation structure and robust variance will be used to compare change between the early and delayed intervention groups adjusting for baseline UTD screening rates of the targeted communities. Adjustment for baseline UTD screening rates and rates of follow up for abnormal test will control for any differences by intervention group due to chance and will increase power by decreasing the standard error of the treatment effect. To account for differences in number of respondents across targeted communities, GEE models will be weighted using an approach described by Johnson et al.
Status of follow-up for abnormal tests (Early Intervention Wave)
Time frame: At baseline and at the end of the Implementation Phase (up to 4 years)
Will be assessed by the difference in follow-up rates for abnormal tests using EHR data. GEE models with compound symmetry correlation structure and robust variance will be used to compare change between the early and delayed intervention groups adjusting for baseline UTD screening rates of the targeted communities. Adjustment for baseline UTD screening rates and rates of follow up for abnormal test will control for any differences by intervention group due to chance and will increase power by decreasing the standard error of the treatment effect. To account for differences in number of respondents across targeted communities, GEE models will be weighted using an approach described by Johnson et al.
1 secondary outcome
UTD screening status for all three cancers and follow up rates for abnormal tests
Time frame: At the end of early intervention (up to 2.5 years)
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 24 Dec 2025.
- The JameslineLink provided by the sponsor.
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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 Ohio State University Comprehensive Cancer Center contact
Electra D Paskett, PhD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cancer Screening, Discussion and Educational Activity in people with Breast Carcinoma and Cervical Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site 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 4 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact The Ohio State University Comprehensive Cancer Center (800-293-5066, OSUCCCClinicaltrials@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Up to date (UTD) status for all three screenings (Early Intervention Wave) (time frame: At baseline and at the end of the Implementation Phase (up to 4 years)). The study lists 2 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 24 Dec 2025.