Health TrialsbyHealthPanel

The Ohio State University (OSU) SCREEN Community Program

ConditionsBreast CarcinomaCervical CarcinomaColorectal Carcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorOhio State University Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Sequential

Treatments tested in this trial

  • Cancer Screening

    Other intervention

    Undergo cancer screening

  • Discussion

    Other intervention

    Participate in discussions

  • Educational Activity

    Other intervention

    Receive coaching calls

  • Educational Intervention

    Other intervention

    Receive educational materials

  • Focus Group

    Behavioral

    Participate in focus group

  • Health Care Delivery

    Other intervention

    Integrate new activities into usual clinic processes

  • Health Promotion

    Other intervention

    Promote screening and wellness visits

  • Health Promotion and Education

    Other intervention

    Participate in educational sessions

  • Health Promotion and Education

    Other intervention

    Participate in early wave MLI

  • Health Promotion and Education

    Other intervention

    Participate in late wave MLI

  • Health Risk Assessment

    Behavioral

    Incorporate risk assessments

  • Implementation

    Procedure/Surgery

    Implement MLI

  • Informational Intervention

    Other intervention

    Review MLI materials

  • Internet-Based Intervention

    Other intervention

    Receive educational online materials

  • Interview

    Other intervention

    Participate in interview

  • Outreach

    Behavioral

    Receive outreach activities

  • Patient Navigation

    Behavioral

    Receive access to CHW

  • Survey Administration

    Other intervention

    Ancillary studies

Treatment groups

2,067 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Phase I, Planning Phase (MLI material, focus group, interview)Other 3 interventions
Group B: Phase II, Arm I (Health Clinics)Active comparator 5 interventions
Group C: Phase II, Arm II (Health Care Providers)Active comparator 5 interventions
Group D: Phase II, Arm III (Patients)Active comparator 4 interventions
Group E: Phase II, Arm IV (Community)Active comparator 4 interventions
Group F: Phase III and IV, Arm V (MLI Early Wave)Experimental treatment 1 intervention
Group G: Phase III and IV, Arm VI (MLI Delayed Wave)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
At baseline and at the end of the Implementation Phase (up to 4 years)
2

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.

Time frame
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.

Time frame
At the end of early intervention (up to 2.5 years)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ohio State University Comprehensive Cancer Center

Lead sponsor

American Cancer Society, Inc.

Collaborator

Source ClinicalTrials.gov
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