Hematopoietic and Lymphoid System NeoplasmNCT06314672
Outreach Project to Connect Underrepresented Populations to Clinical Trials at Ohio State University, CUSP2CT Project Trial
A study testing Accrual, Discussion and Educational Activity in people with Hematopoietic and Lymphoid System Neoplasm and Malignant Solid Neoplasm, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This clinical trial tests the impact of the The Ohio State University Connecting Underrepresented Populations to Clinical Trials (CUSP2CT) project on clinical trial referrals and enrollment in racial/ethnic minorities. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Accrual, Discussion and Educational Activity
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2023to 31 Dec 2028
- 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
- Phase I: 9 counties in the OSUCCC catchment area
- Phase II: Patients, providers, and hospital systems/referral centers that directly addresses challenges identified in Phase I
- Phase II: The project will involve the OSUCCC, the OSU James Cancer Network sites and the Columbus and Dayton NCORP sites
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.
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, PhD
About this study
Official title: The Ohio State University Connecting Underrepresented Populations to Clinical Trials (CUSP2CT) Project
This clinical trial tests the impact of the The Ohio State University Connecting Underrepresented Populations to Clinical Trials (CUSP2CT) project on clinical trial referrals and enrollment in racial/ethnic minorities. Progress in cancer prevention, detection and treatment can only be made by identifying and validating new and improved methods, compounds and modalities in clinical trials. Unfortunately, participation in clinical trials is not equal across all racial and ethnic groups, limiting progress against cancer in all population groups and further widening the disparity gap. To change this picture, concerted effort needs to be directed both at the communities at risk for being left out of trials and the systems that cause the disparities at all levels involved in accrual to clinical trials. The CUSP2CT project may have the potential to increase referral and accrual of racial/ethnic minorities to prevention/control and treatment trials.
Read the detailed description
PRIMARY OBJECTIVES:
- Conduct a baseline assessment of referral patterns and accrual of racial and ethnic minorities to clinical trials at Ohio State University Comprehensive Cancer Center (OSUCCC) by cancer disease group (breast, gastrointestinal, genitourinary, thoracic, hematologic,and others) and examine factors at the system (i.e., eligible clinical trial protocol, clinic context and culture), provider (trial discussed with patient) and patient levels (agreed or refused participation) that influence referral and accrual. (Phase I) II. Implement a multi-level intervention in a stepped wedge design in referral in 10 counties in the OSUCCC catchment area using the Accrual to Clinical Trials framework. (Phase II) III. Evaluate the impact of the intervention on referral (primary outcome) and accrual (secondary outcomes) to clinical trials. (Phase III)
OUTLINE: Counties are cluster randomized to 1 of 3 steps in Phase II of the study.
PHASE I (DEVELOPMENT): Community members, clinic staff, and providers undergo in-depth interview for intervention development on study. Researchers review baseline data on referral patterns and accrual of racial and ethnic minorities to clinical trials in each clinic site. Providers, clinical staff, and research team participate in implementation discussion. Accrual enhancement program (AEP) strategies developed and initiated in one OSUCCC/James clinic. Providers and community members participate in educational sessions on study. (Year 1)
PHASE II (IMPLEMENTATION): Participants participate in the AEP in the remaining clinics at OSUCCC/James and community clinics on study. Community members and providers participate in culturally tailored educational activities. Providers, patients, and community members participate in interviews to explore current barriers to referral and participation on study. (Years 2-4)
PHASE III (EVALUATION): Providers, clinic staff, patients, and community members participate in interviews to explore current barriers to referral and participation. (Year 5)
- Being tested
- Accrual, Discussion, Educational Activity, Interview, Review
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AccrualProcedure or surgery
Participate in AEP
DiscussionProcedure or surgery
Also called Discuss
Participate in implementation discussions
Educational ActivityOther
Participate in educational sessions/activities
InterviewOther
Undergo interview
ReviewOther
Undergo data capture review
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Phase I (interview, discussion, review, AEP, education) | Experimental | Community members, clinic staff, and providers undergo in-depth interview for intervention development on study. Researchers review baseline data on referral patterns and accrual of racial and ethnic minorities to clinical trials in each clinic site. Providers, clinical staff, and research team participate in implementation discussion. AEP strategies developed and initiated in one OSUCCC/James clinic. Providers and community members participate in educational sessions on study. (Year 1) Receives: Procedure: Accrual; Procedure: Discussion; Other: Educational Activity; Other: Interview; Other: Review; Other: Survey Administration |
| Phase II (AEP, education, interviews) | Experimental | Participants participate in the AEP in the remaining clinics at OSUCCC/James and community clinics on study. Community members and providers participate in culturally tailored educational activities. Providers, patients, and community members participate in interviews to explore current barriers to referral and participation on study. (Years 2-4) Receives: Procedure: Accrual; Other: Educational Activity; Other: Interview; Other: Survey Administration |
| Phase III (interview) | Experimental | Providers, clinic staff, patients, and community members participate in interviews to explore current barriers to referral and participation. (Year 5) Receives: Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in referral rate to clinical trials (CTs) (short-term outcomes)
Calculate change in clinical trial referrals
Measured: Baseline to 24 months
Change in accrual of minorities to CTs (short-term outcomes)
Calculate the change in clinical trial minority enrollments
Measured: Baseline to 24 months
CT accrual and retention due to patient navigation (short-term outcomes)
Calculate accrual and retention rates
Measured: Baseline to 24 months
Identification of program gaps in trial accrual (long-term outcomes)
Define gaps in trial accrual
Measured: Up to 24 months
Uptake of program in other clinics (long-germ outcomes)
Calculate the number of clinics who adapt program
Measured: Up to 24 months
Secondary outcomes (1)
Probability of trial enrollment and retention
Recent regression models used for stepped wedge designs that flexibly model the effect curve of the intervention over time. Effect estimates and 95% confidence intervals will accompany significance tests, and graphical displays of the final effect curve will aid in understanding the efficacy of the intervention.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start22 Aug 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid System NeoplasmStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- 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
- NCT06314672
- Sponsor's protocol ID
- OSU-22318
- Other IDs
- NCI-2023-02217, U01CA274999
- Status last verified
- Jun 2026
- First submitted
- 31 Oct 2023
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ohio State University Connecting Underrepresented Populations to Clinical Trials (CUSP2CT) Project
- ClinicalTrials.gov ID
- NCT06314672
- Acronym / sponsor ID
- OSU-22318
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 22 Aug 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 18 Mar 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 tests the impact of the The Ohio State University Connecting Underrepresented Populations to Clinical Trials (CUSP2CT) project on clinical trial referrals and enrollment in racial/ethnic minorities. Progress in cancer prevention, detection and treatment can only be made by identifying and validating new and improved methods, compounds and modalities in clinical trials. Unfortunately, participation in clinical trials is not equal across all racial and ethnic groups, limiting progress against cancer in all population groups and further widening the disparity gap. To change this picture, concerted effort needs to be directed both at the communities at risk for being left out of trials and the systems that cause the disparities at all levels involved in accrual to clinical trials. The CUSP2CT project may have the potential to increase referral and accrual of racial/ethnic minorities to prevention/control and treatment trials.
Detailed description
PRIMARY OBJECTIVES:
- Conduct a baseline assessment of referral patterns and accrual of racial and ethnic minorities to clinical trials at Ohio State University Comprehensive Cancer Center (OSUCCC) by cancer disease group (breast, gastrointestinal, genitourinary, thoracic, hematologic,and others) and examine factors at the system (i.e., eligible clinical trial protocol, clinic context and culture), provider (trial discussed with patient) and patient levels (agreed or refused participation) that influence referral and accrual. (Phase I) II. Implement a multi-level intervention in a stepped wedge design in referral in 10 counties in the OSUCCC catchment area using the Accrual to Clinical Trials framework. (Phase II) III. Evaluate the impact of the intervention on referral (primary outcome) and accrual (secondary outcomes) to clinical trials. (Phase III)
OUTLINE: Counties are cluster randomized to 1 of 3 steps in Phase II of the study.
PHASE I (DEVELOPMENT): Community members, clinic staff, and providers undergo in-depth interview for intervention development on study. Researchers review baseline data on referral patterns and accrual of racial and ethnic minorities to clinical trials in each clinic site. Providers, clinical staff, and research team participate in implementation discussion. Accrual enhancement program (AEP) strategies developed and initiated in one OSUCCC/James clinic. Providers and community members participate in educational sessions on study. (Year 1)
PHASE II (IMPLEMENTATION): Participants participate in the AEP in the remaining clinics at OSUCCC/James and community clinics on study. Community members and providers participate in culturally tailored educational activities. Providers, patients, and community members participate in interviews to explore current barriers to referral and participation on study. (Years 2-4)
PHASE III (EVALUATION): Providers, clinic staff, patients, and community members participate in interviews to explore current barriers to referral and participation. (Year 5)
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase I (interview, discussion, review, AEP, education) | Experimental | Procedure: Accrual, Procedure: Discussion, Other: Educational Activity, Other: Interview, Other: Review, Other: Survey AdministrationCommunity members, clinic staff, and providers undergo in-depth interview for intervention development on study. Researchers review baseline data on referral patterns and accrual of racial and ethnic minorities to clinical trials in each clinic site. Providers, clinical staff, and research team participate in implementation discussion. AEP strategies developed and initiated in one OSUCCC/James clinic. Providers and community members participate in educational sessions on study. (Year 1) |
| Phase II (AEP, education, interviews) | Experimental | Procedure: Accrual, Other: Educational Activity, Other: Interview, Other: Survey AdministrationParticipants participate in the AEP in the remaining clinics at OSUCCC/James and community clinics on study. Community members and providers participate in culturally tailored educational activities. Providers, patients, and community members participate in interviews to explore current barriers to referral and participation on study. (Years 2-4) |
| Phase III (interview) | Experimental | Other: InterviewProviders, clinic staff, patients, and community members participate in interviews to explore current barriers to referral and participation. (Year 5) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Phase I: 9 counties in the OSUCCC catchment area
- Phase II: Patients, providers, and hospital systems/referral centers that directly addresses challenges identified in Phase I
- Phase II: The project will involve the OSUCCC, the OSU James Cancer Network sites and the Columbus and Dayton NCORP sites
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 |
|---|---|---|
| AccrualParticipate in AEP | Procedure or surgery | Phase I (interview, discussion, review, AEP, education), Phase II (AEP, education, interviews) |
| DiscussionAlso: DiscussParticipate in implementation discussions | Procedure or surgery | Phase I (interview, discussion, review, AEP, education) |
| Educational ActivityParticipate in educational sessions/activities | Other | Phase I (interview, discussion, review, AEP, education), Phase II (AEP, education, interviews) |
| InterviewUndergo interview | Other | Phase I (interview, discussion, review, AEP, education), Phase II (AEP, education, interviews), Phase III (interview) |
| ReviewUndergo data capture review | Other | Phase I (interview, discussion, review, AEP, education) |
| Survey AdministrationAncillary studies | Other | Phase I (interview, discussion, review, AEP, education), Phase II (AEP, education, interviews) |
Primary outcome
Change in referral rate to clinical trials (CTs) (short-term outcomes)
Time frame: Baseline to 24 months
Calculate change in clinical trial referrals
Change in accrual of minorities to CTs (short-term outcomes)
Time frame: Baseline to 24 months
Calculate the change in clinical trial minority enrollments
CT accrual and retention due to patient navigation (short-term outcomes)
Time frame: Baseline to 24 months
Calculate accrual and retention rates
Identification of program gaps in trial accrual (long-term outcomes)
Time frame: Up to 24 months
Define gaps in trial accrual
Uptake of program in other clinics (long-germ outcomes)
Time frame: Up to 24 months
Calculate the number of clinics who adapt program
1 secondary outcome
Probability of trial enrollment and retention
Time frame: Up to 24 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 9 Jun 2026.
- The JameslineLink provided by the sponsor.
- 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.
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 Accrual, Discussion and Educational Activity in people with Hematopoietic and Lymphoid System Neoplasm and Malignant Solid Neoplasm, 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 3 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 9 Jun 2026. 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 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?
Change in referral rate to clinical trials (CTs) (short-term outcomes) (time frame: Baseline to 24 months). The study lists 5 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 9 Jun 2026.